Motivations for participation in a spinal cord epidural stimulation study: Perspectives of individuals with spinal cord injury and their caregivers

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OBJECTIVES: Spinal cord epidural stimulation (scES) has shown promise for improving autonomic and motor function in individuals with spinal cord injury (SCI). Participation on translational studies often requires relocation, uprooting the individual and caregivers from their community. This study aimed to explore the motivations and expectations driving the decision to participate in a scES study. SETTING: Interviews were conducted at enrollment in a randomized trial evaluating scES efficacy at the Kentucky Spinal Cord Injury Research Center, University of Louisville, USA. METHODS: 23 interviews were conducted with 18 individuals with SCI (40 + 10 years old, 12 + 10 years since injury, 44% males, all cervical, ASIA Impairment Scale: 39% A, 39% B, 22% C) and 5 caregivers. Interviews were audio recorded, transcribed, and analyzed with a thematic approach. RESULTS: Four main themes emerged: gaining independence, improving function, benevolence, and other. Participants and caregivers hoped that improved function would lead to more independence—described as “a little more freedom,” “experience the world,” and to “not rely on someone.” Any change was expressed as improving the quality of life. Many managed their expectations by recognizing the impact of individual characteristics on outcomes. Even if no improvement occurred, participation felt meaningful—motivated by benevolence and a desire to advance SCI research and help others. CONCLUSIONS: People with SCI and their caregivers participate in scES research with cautious hope to gain freedom and improve quality of life through improved function. They also aim to help others through advancing science. SPONSORHIP : This work was funded by DoD (W81XWH-19-1-0734). The parent study was funded by Christopher and Dana Reeve Foundation, Leona M. & Harry B. Helmsley Charitable Trust, and Medtronic Plc for spinal cord epidural stimulation implants. Health sciences/Medical research Health sciences/Medical research/Clinical trial design/Randomized controlled trials Spinal cord injury epidural stimulation motivation perspective translational trials Figures Figure 1 Figure 2 Figure 3 Introduction The most recent estimate of Spinal Cord Injury (SCI) in 2024, is an annual incidence of approximately 18,000 new cases each year in the United States (US), with a total prevalence around 305,000 individuals living with this injury( 1 ). SCI directly impacts the normal physiology of the body, causing dysfunction of the neurologic, cardiovascular, respiratory, digestive, and genital-urinary systems. Secondary to these physiological changes, the quality of life and psychosocial areas are also impacted on these individuals and their close relationships. Individuals with SCI are frequently cared for by family members. The assistance required can range from physical tasks – such as bowel and bladder management- to support with activities of daily living, financial management, decision-making and coordination of care( 2 , 3 ). The daily time commitment and emotional stress of providing long-term care for a loved one have consistently shown in literature to negatively impact caregiver’s health and quality of life, primarily due to increased physical, emotional, and financial burden( 3 ). Spinal cord epidural stimulation (scES), FDA-approved for pain management, has been investigated and shown promise for improving cardiovascular( 4 ), motor( 4 , 5 ), bowel and bladder( 6 – 8 ) function and improving quality of life in SCI. Although scES requires surgical implantation of a device into the spinal cord, ongoing research continues to investigate its therapeutic potential for SCI. Currently, only a limited number of research centers perform translational studies, and participation often requires relocation, uprooting the individual and, their caregivers from their community, and a commitment to an intense daily rehabilitation program regimen. Individuals who consent to participate in clinical trials often misunderstand the purpose of research interventions that include a clinical care component. This confusion, known as “therapeutic misconception”( 9 ) was first identified decades ago and refers to the mistaken belief that the primary goal of clinical research is to provide therapeutic benefit to participants, rather than to generate generalizable knowledge. While both clinical care and clinical research can positively impact specific populations, their goals are fundamentally different, while the goal of clinical care is to offer an individualized approach for patients, considering their specific needs and prioritizing their well-being. In contrast, clinical research is focused on discovering new knowledge that may benefit a population with the same condition. The effects of therapeutic misconception could be perceived as something positive to enrollment rates; however, it could have a negative impact by not meeting the participant’s expectations, resulting in increased study dropout and overall resentment with the research process( 10 ). Moreover, participants and their caregivers often agree to participate in research for conditional altruism( 11 ), referring to the willingness to help others, but that is unlikely to lead to trial participation unless there is a personal gain( 12 ). The high hopes for the possibility of neurological benefits and recovery could also lead to higher tolerance of risks related to participating in experimental studies( 13 ). Furthermore, hopes on improving function could be translated into less caregiver reliance( 14 ), potentially adding to the willingness of both, individuals with SCI and their caregivers, to participate in clinical research. Clinical trials, such as the scES study, are the based on finding treatment alternatives for SCI. Despite the advances offered on scientific and medical knowledge, trials often suffer from poor enrollment which yields limited useful knowledge for patients( 15 ). Although some studies have investigated motivators of research participation, many rely on structured methods and are designed to describe the likelihood of participation( 16 , 17 ) with results varying depending on country( 18 ), type of study( 19 ), and disease related population. Even though studies evaluating participation among individuals with SCI are insightful, they are primarily based on structured surveys with predefined response options, limiting the ability to investigate deeper perceptions and experiences. Currently, the motivation for individuals with SCI to participate in a study involving an invasive procedure remains understudied. The aim of this study was to explore the motivations and expectations driving the decision of people with SCI to participate in a scES study and to understand caregiver perception. This knowledge could help address expectations during the consent process, and create engagement strategies and tools for future studies, prioritizing the most important needs and interests in the population living with SCI. Methods Participants This study assessed pre-intervention data from 18 individuals with chronic cervical spinal cord injury. Participants were enrolled in the study “T argeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury ”, hereafter referred to as “Bowel function study”. The Bowel function study was an ancillary or “piggy-back” study, recruiting participants who were already enrolled in an on-going study, sponsored by the Christopher and Dana Reeve Foundation and The Leona M. and Harry B. Helmsley Charitable Trust, within the epidural SCI research program at our research institution (“ Task and physiological specific stimulation for recovery of autonomic function, voluntary movement and standing using epidural stimulation and training after severe spinal cord injury ,” TS-EPI, short name). TS-EPI, the parent study Participants received a spinal cord epidural stimulator implantation over the lumbosacral cord. After implantation, they were randomized into four groups. All groups received two training interventions of 80 sessions each; at least one training intervention that included spinal cord epidural stimulation targeted for standing with activity-based recovery training (Stand-ABRT). All groups received targeted cardiovascular spinal cord epidural stimulation (CV-scES) or targeted voluntary movement of spinal cord epidural stimulation (Vol-scES), (Fig. 1 ). The study included five timepoint assessments; ( 1 ) pre-training, ( 2 ) after 80 sessions of training, ( 3 ) after 160 sessions of training, and at the ( 4 ) 6- and ( 5 ) 12-month follow-up time points. Clinical trial results will be published in a subsequent publication. The Bowel Function study Assessed bowel-related outcomes to evaluate the potential neuromodulatory effects of scES. The study assessed whether scES, targeted for regulating blood pressure, could improve bowel motility and decrease episodes of autonomic dysreflexia during a bowel program. Additionally, assessed whether scES used for activating the trunk and core could improve bowel evacuation by enhancing awareness of rectal fullness and improving the coordination of internal and external sphincter dynamics. Lastly, through qualitative methods, it assessed if alterations in bowel function were associated with quality-of-life improvements. The Current Project This study is a secondary analysis of the qualitative portion of the Bowel Function study. Data were collected through semi-structured telephone interviews with participants and caregivers at enrollment in the TS-EPI study. The interview guides were designed to elicit participants and their caregivers' perspectives of changes associated with scES. Two different guides were created, one specific for participants and a second for caregivers’ experience. For this study, we included domains related to how participants enrolled in the program; what motivated them to enroll, if they encountered barriers or challenges to seeking the program, if they had tried other therapies, and what they expected the program to provide that they didn’t have found so far. Domains included in the caregiver’s guide included what they knew about the participants' motives to enroll and what they were expecting this program would provide to the participants. Caregiver and participant interviews were conducted separately to encourage candid and independent responses. The interviews were led by personnel with experience conducting open-ended, semi-structured interviews and who were not involved in study operations or data collection. Interviews were evaluated until no new insights were emerging ( 20 , 21 ). Discussion guides are included as Supplementary Material Appendix 1 and 2 . Audio recordings were transcribed from voice to text by two independent researchers. A third member of the research team reviewed the transcribed text to make sure it was accurate. Data analysis Qualitative analysis was conducted with a thematic analysis approach( 22 ) to evaluate participant and caregiver experiences and perspectives of improvement in bowel function. Dedoose, qualitative software, was used to organize and analyze data. Qualitative coding was characterized by a combination of deductive and inductive approaches and proceeded in two rounds. In the first round, three different researchers generated a codebook individually from the domains utilized in the discussion guide. Additional codes were added inductively through an iterative process of initial coding. The team discussed the proposed codes, and two rounds of coding were made to ensure the revised coding scheme was applied uniformly. Every transcript was coded by one member of the team and reviewed for accuracy and completeness by a second member. All inconsistencies were then discussed to clarify the coding scheme and resolve inconsistencies. For this study, we extracted excerpts coded under “Motivation for Enrolling in the study”. This included those coded under subthemes “Gain independence,” “Gain improvement in function,” “Benevolence” and “Other.” For dissemination purposes, excerpts were edited to remove identifying information, and for clarity if this could be accomplished without removing meaning. For example, some filler words and phrases were removed.” The full excerpts are included in Supplementary Appendix 3. Ethical considerations Participants were enrolled in the TS-EPI study, IRB #16.0179, at the Kentucky Spinal Cord Injury Research Center (KSCIRC) at the University of Louisville (UofL) and were required to sign an additional informed consent for participation in the bowel function study, IRB #19.0435. Results Participant Characteristics : A total of 18 individuals with SCI and 5 caregivers (Table 1 ) were enrolled (40 ± 10 years old, 12 ± 10 years since injury, 44.4% males, all cervical, ASIA Impairment Scale (AIS): 39% A, 39% B, 22% C). Most caregivers were participants’ mothers (60%), followed by fathers (20%) and partner/spouses (20%) (Table 2 ). Table 1 Demographic and clinical characteristics Pub ID Age (yrs) Gender Level of Injury AIS Time since injury (yrs) A64 58 Male C4 A 41 B42 60 Male C4 C 9 A97 40 Male C4 A 16 B38 24 Male C4 B 5 A102 31 Female C4 A 7 B45 37 Male C5 B 11 B40 37 Male C4 B 5 B52 54 Female C6 B 10 A119 28 Female C5 A 13 A128 40 Male C4 A 10 A127 42 Female C4 A 14 A133 36 Male C4 A 14 B194 39 Female C4 C 20 B192 43 Female C5 B 29 C193 42 Female C4 C 9 B212 48 Female C4 B 30 B213 25 Female C4 B 6 C237 42 Female C4 C 25 Pub ID : Publication ID; AIS : American Spinal Injury Association Impairment Scale. Table 2 Demographics of caregivers CG : Caregiver. Pub ID Relationship Age Race/Ethnicity B38 CG Mother 49 Non-Hispanic/Latino A102 CG Mother 59 White A127 CG Mother 60 Hispanic/Latino B42 CG Spouse 56 White B40 CG Father 65 Caucasian/White Motivations for enrolling in the epidural stimulation study We conducted 23 semi-structured interviews with participants and their caregivers at the time of enrollment. 94% of participants (N = 17) mentioned a motivator to enroll. 85 excerpts themed under “Motivation for Enrollment in the Study” were extracted and analyzed (Fig. 2 ). Most of the excerpts were coded with more than one code ( Supplemental Table 1 ). Emergent themes showed that 78% enrolled in the study hoping to have improvements in function, 72% to gain independence, 28% for benevolence, and 44% mentioned other reasons. All caregivers expressed hopes for function improvements; 60% were hoping for more independence, and 40% for benevolence (Fig. 3 ). Interview Findings (Table 3 ) Table 3 Examples of excerpts extracted from Dedoose Software under “Motivation for Enrolling in Study”. Theme Excerpt Examples Improvements in Function “I look at this research as potentially life extending and if it can improve my autonomic functions such as normalizing blood pressure or improving the bowel or bladder activity, that would be an unbelievable success” ( Pub ID A64 ). “The idea of being able to regulate my blood pressure was a big thing (...) having a device that works to regulate my blood pressure, depending on what activity is going on, that’s what really interested me” ( Pub ID A97 ). “If I could regain control over my bowel and bladder, that would be fantastic” ( Pub ID C237 ). “You want it all, but you are going to be happy wherever you get. (...) as far as bowel and bladder; it would be amazing to not have to use enema” ( Pub ID B192 ). “I'm going to see what happens and hope for the best but also be cautious with my optimism (...) anything I gain is going to be something that I wasn't going to get back home ( Pub ID C237 ). “I thought that if it could improve anything, why not go for it? I have everything to gain but nothing to lose” (Pub ID B192). Gain Independence “I would like to be able to stand. I don’t need to run a marathon. If I could stand up and adjust myself in the chair” (Pub ID B42). “I would love to be able to pee when I want to, from how it should be not from having this tube” (Pub ID B213). “Even if I can stand without having necessarily a standing wheelchair would be huge, just to be able to reach things, instead I have to spend 15–20 minutes looking for somebody to help me reach something (…) to be able to cook, or do different things around the house, or make it easier to go shopping” ( Pub ID C237 ). I want to better my life, become more independent and be healthier (...) I want to improve every function, if that includes bowels, then I want to do it ( Pub ID B194 ). “We are hoping that it will give a little bit more freedom. I’m not saying to go jump up and run the Boston Marathon, but if this program could help to get bowel and bladder function back, even just stand up enough to adjust so he’s comfortable and doesn’t have to rely on someone to do it” (Pub ID B42 CG). mentioned “I wish my bowels would start working again to where I could do more of it on my own (...) I could save her a whole lot of wear and tear on her knees” ( Pub ID B42 ). “For the study, the goal (...): however, I can find ways to regain function to limit the needs I have with caregiving” (Pub ID A133). Benevolence “I want to try and help advance the research. If you thought about the polio community, they came up with a vaccine for polio, they eradicated polio, but they forgot about those who were already paralyzed by polio (...) I don’t want that to happen to this field (Pub ID A64). “She has to do this now to reach the end goal, not only for her, but for everyone else in the community. If she doesn’t do it and the next person doesn’t want to do it- you’re not going to move forward as a whole” ( Pub ID A102 ). Other “Seeing proof of the benefit” though previous participants, was very compelling ( Pub ID A64 ). “I’ve spoken to a lot of people who’ve gone through it; most people have had improvements one way or the other, but they’re not all walking out of the lab. But I do look at and define a “cure” as any degree of improvement” ( Pub ID A64 ). “Better overall health, anything that can improve your longevity or improve your quality of life whatever that may be to you as an individual” ( Pub ID B192 ). “That it was sponsored, paid for, or whatever by the Christopher Reeve Foundation. I figured anything they have been involved in was probably pretty legit” ( Pub ID B212 ). Improvements in Function To gain improvement in function was the most prevalent theme. Most of the participants who enrolled into the epidural stimulation study were hoping to have improvements in function, with most citing functions such as bowel, bladder, sexual, cardiovascular, and thermoregulation, but also motor functions such as hands and fingers control, trunk and leg muscle strength, voluntary movement, and standing. Although most participants expressed hope for functional improvements, they remained cautious with their hopes and optimism. Still, they believed that participating in the study offered a better chance of improvement than staying home. Overall, the potential for personal benefit related to function was more perceived as beneficial rather than a risk. Gain Independence Hopes for more independence were expressed as “ a little bit more freedom” to “experience the world a little bit more.” Consistently, the hopes to gain more function such as standing, walking, bowel and bladder function, and transfer, were related to being more independent and being able to perform activities of daily living on their own and reduce the amount of time invested. They expressed wishes to adjust themselves in the wheelchair and to urinate without the support of a urinary catheter. Improvements in bowel and bladder function were mentioned as gaining independence; “I would like to do it on my own,” “when I want to,” and “ how it is supposed to be ”. Caregivers mentioned they were hoping this study would give them a “little bit of freedom” by improving participant’s bowel and bladder function. Participants expressed hopes that improved function and greater independence would lessen caregiver burden and enhance their relationship -particularly when caregivers were close personal relationships. Even small functional gains were expected to reduce the time caregivers needed to provide support. Benevolence Even if there was no change at the end of the study, participants and caregivers believed that it was important to participate for “Benevolence”, to researchers learn from them to contribute to the advancement of research in the field of SCI and potentially help people in the future. Contributing knowledge for the community with SCI, was described as the “end goal”. One of their concerns was that the research field forgot about those who have chronic SCI, and there were no advancements. Participants were also aware this study was experimental and the reason they participated was to help other individuals. Additionally, caregivers were motivated to participate in clinical trials to “reach the end goal”, not for personal benefit but to help the SCI community “to move forward as a whole”. Other reasons to enroll Experiences from other participants motivated some individuals with SCI to enroll, regardless of being integrated in the community, having a job and their own business. “ Seeing proof of the benefit ” though previous participants, was very compelling. They mentioned being aware that “ walking out of the lab ” was not the experience of other participants, but “ cure ” was any degree of improvement. Additionally, they enrolled hoping to improve their quality of life by improving function, overall health, longevity, and independence. Lastly, they relied on the sponsors reputation to enroll. Discussion Our findings suggest that the main motivator for an individual with SCI to enroll in a scES study is to improve function (78%) and gain independence (72%) to ease caregivers’ burden. Those who mentioned enrolling for benevolence (23%), were hoping for researchers to learn from them to help the community with SCI. Almost a half of the participants (44%) mentioned other reasons such as: improving quality of life and overall health, as well as being motivated by previous participants experiences. Function improvements, mentioned by 78% of the participants, was the main motivator for individuals with SCI to enroll into a clinical study. Improvements in motor, cardiovascular, bowel and bladder function, and core strength were repeatedly cited. Cardiovascular function was mentioned as hope to control blood pressure. Regarding bowel and bladder function, they were hoping for full recovery someday, but an increase in sensation was a goal for the TS-EPI study. They were wishing for improved core strength, to be able to be seated straight in their chair or not be scared to falling during transfers. Some of them defined the cure as “whatever improvement they could have.” Individuals with SCI expressed they were not hoping to walk again or run a marathon out of the study; but whatever improvement they had was worthwhile recovery. This finding is consistent with a multi-national survey study( 16 ), which found that “improvement in functionality” was the number one facilitator for individuals with SCI to participate in a clinical study. Another study investigating functional priorities in persons with SCI, 44–76% of participants with cervical injuries were more likely to choose arm/hand function over other functions such as walking, bladder/bowel control, sexual function, and relief of pain( 23 ). While priority in improving function was expected based on previous literature( 24 ), our findings offer a deeper insight into the perspectives and functional concerns of individuals with SCI. Functional improvements were frequently related to gaining independence; 72% of participants were hoping to be more independent out of the study to reduce the workload on their caregivers, to be able to do more things at home, and to experience life more. They expressed that by improving their bladder and bowel functions and muscle strength, they would be able to do more things on their own. Core strength was continually mentioned to be able to sit up on their own, and to have more balance for better use of their wheelchair. Independence was mentioned as doing activities of daily living; reaching things without help and being able to transfer. Improvements in care and rehabilitation have resulted in an increased population living with SCI. Secondary to this increase, individuals with chronic disabilities and researchers have shifted focus to independence, participation, and autonomy( 25 ). Our findings shed light on the meaning of regaining function and independence for individuals with SCI; since many of them mentioned they would like to be more independent to reduce the work on their caregivers. Whereas social support has been previously related to better health, functioning, and well-being( 26 ), reciprocity -where the individual with SCI can help the caregiver in other aspects- is a crucial factor for healthy support between family or marital relationships with an individual with SCI( 27 ). Continuing research on function improvements that can help individuals with chronic SCI have an independent life should be the focus of current and future investigations. Additionally, including caregiver education in clinical trials could be beneficial for both individuals to reduce the strain in the relationship, particularly in long-term studies where caregiving demands tend to be higher. Furthermore, participants enrolled hoping to improve their quality of life; they expected that by improving function, independence, and overall health, they could reach this goal. A recent study by Roth et al.( 28 ), showed that, in individuals with chronic SCI, perspectives of quality of life vary depending on the time since injury; recovery is most important for those with 1–5 years of injury, navigating the community and handing difficult situations for those with 5–15 years of injury, and self-reflection and handling challenges positively for those with more than 15 years of injury. In our study, two of the participants hoped to improve quality of life by improving function and independence, both with 9 years since injury. However, another participant with 29 years since injury who enrolled to improve quality of life was hoping to have better health and longevity. Several studies have shown that quality of life is not strongly influenced by physical variables( 29 – 31 ). In contrast, personal characteristics such as positive emotions( 32 ), optimism( 33 ), hope( 32 – 34 ), coherence( 35 ), and psychological dynamics, as coping strategies( 36 ), can improve and predict quality of life over time. Providing psychological and educational support during long clinical trials may enhance participants’ quality of life, improve their overall experience, and help align outcomes with study expectations. Those who enrolled in the study for benevolence (28%), mentioned that being part of scientific research breakthroughs was important to them, regardless of having function back. This is different from other populations( 12 ), where benevolence was conditioned into having function back or an economic gain. The difference in their response may be attributed to individuals with chronic SCI having been told repeatedly that recovery is not possible. They have learned to “manage their expectations” and consider being part of research for the greater good. However, the hopes for improvement were expressed most of the time. Individuals' participation in research has been acknowledged for some time now( 37 ) whereas there are recent survey studies regarding facilitators, barriers( 16 ) and priorities( 24 , 38 ) of individuals with SCI, the overall response to participate in clinical trials remains low, especially when it involves a procedure, and the risks are explained. This study gives us an insight into what was meaningful to individuals with SCI who were enrolled in a clinical study that included an invasive procedure. The knowledge obtained from this study could help future researchers design clinical trials in a way that cover the main concerns of the population with SCI. Additionally, this knowledge should encourage researchers to continue studying questions that improve function of individuals with SCI focused on gaining independence, with the premise that “cure or recovery is whatever improvement they can have”, whereas we continue working towards recovering total function, having an improvement in bowel, urinary, cardiovascular or motor function, could be highly meaningful to them working as a motivator to participate in clinical trials and contribute to scientific breakthroughs. Strength and Limitations This study's strength is based on the focus of integrating the participant and caregiver’s insight into a quantitative study. Qualitative studies provide detailed insight about a specific topic; with semi-structured interviews, it is more likely to garner detailed responses; they provide the flexibility to ask clarifying questions and probe deeper into responses. While providing rich detail in participants and caregiver experiences could help inform future developments, there were a few limitations. This study may not be representative of the SCI population and may be limited due to the likelihood that a certain type of participant with a particular viewpoint, elected to take part in this study. Another limitation is that this study is only evaluating the enrollment period and does not cover post-training interviews and met expectations after the study were not assessed. However, this is planned as part of a future study. Despite limitations, semi-structured interviews help us to listen to participants’ perspectives and thoughts which should always be considered at the time of planning clinical trials. Considering their needs is crucial to enhance research practice. Conclusion People with SCI and their caregivers participate in scES research studies with a sense of cautious hope to improve function. Their wishes to recover function was tightly related to gain independence and reduce work to family and caregivers. Most importantly, regardless of not gaining anything back, they want to at least play a part in scientific breakthroughs aimed at helping the next person with injury live an easier life and with better quality. This knowledge can help to create future research questions that are meaningful to individuals with SCI and to optimize future clinical trials considering what is important for this population. Declarations Acknowledgments: We are indebted to our research participants for their courage, dedication, motivation, and perseverance that made these research findings possible. Drs. Jonathan Hodes and Maxwell Boakye performed surgical implantation and provided medical oversight. Drs. Douglas Stevens, Glen Hirsch, Darryl Kaelin, and Sarah Wagers provided medical oversight. Yukishia Austin, Lynn Robbins, and Kristen Johnson provided medical management. We would like to thank Dr. Yangsheng Chen for engineering leadership, Taylor Blades, and Christie Ferreira for project management. Rebekah Morton, Matthew Green, Paul Criscola, Justin Vogt, Katie Pfost, Katelyn Brockman, Brittany Logdson, Ricky Seither, Kristin Benton, Dylan Pfost, and Joseph Carrico led research interventions and provided support for research participants. We would also like to thank Riley Wilkinson, Ashley Ezzo, Dengzhi Wang, and Erin Wyles for voice to text transcription. Author contributions : Conceptualization : BU, AH. Planning: AH, BU, CH, SH. Investigation: AH, BU, EA, CR. Methodology: AH, BU, KY, CR. Project Administration: EA. Writing Original Draft: EA, BU. Validation: EA, BU, AH, SH, CH. Visualization: EA, BU. Writing – Review and Editing: EA, AH, CR, KB, SH, CH, BU. Funding : This work was funded by DoD (W81XWH-19-1-0734). The parent study was funded by Christopher and Dana Reeve Foundation, Leona M. & Harry B. 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Journal of neurotrauma. 2016;33(21):1958–68. Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004;21(10):1371–83. Lili L, Sunnerhagen KS, Rekand T, Alt Murphy M. Participation and autonomy, independence in activities of daily living and upper extremity functioning in individuals with spinal cord injury. Scientific Reports. 2024;14(1):9120. Müller R, Peter C, Cieza A, Geyh S. The role of social support and social skills in people with spinal cord injury—a systematic review of the literature. Spinal cord. 2012;50(2):94–106. Le Fort M, Lefèvre C, Kieny P, Perrouin-Verbe B, Ravaud J-F. The functioning of social support in long-term prevention after spinal cord injury. A qualitative study. Annals of physical and rehabilitation medicine. 2021;64(4):101454. Roth EJ, Lovell L, Barry A. Perspectives on factors influencing quality of life in persons with long-term spinal cord injury: a qualitative study. Spinal Cord. 2024:1–5. Middleton J, Tran Y, Craig A. Relationship between quality of life and self-efficacy in persons with spinal cord injuries. Archives of physical medicine and rehabilitation. 2007;88(12):1643–8. Lidal IB, Veenstra M, Hjeltnes N, Biering-Sørensen F. Health-related quality of life in persons with long-standing spinal cord injury. Spinal cord. 2008;46(11):710–5. Cardile D, Calderone A, De Luca R, Corallo F, Quartarone A, Calabrò RS. The Quality of Life in Patients with Spinal Cord Injury: Assessment and Rehabilitation. Journal of clinical medicine. 2024;13(6):1820. Kortte KB, Gilbert M, Gorman P, Wegener ST. Positive psychological variables in the prediction of life satisfaction after spinal cord injury. Rehabilitation Psychology. 2010;55(1):40. Mortenson W, Noreau L, Miller W. The relationship between and predictors of quality of life after spinal cord injury at 3 and 15 months after discharge. Spinal cord. 2010;48(1):73–9. Van Leeuwen CM, Post MW, Van Asbeck FW, Bongers-Janssen HM, Van Der Woude LH, De Groot S, et al. Life satisfaction in people with spinal cord injury during the first five years after discharge from inpatient rehabilitation. Disability and rehabilitation. 2012;34(1):76–83. Kennedy P, Lude P, Elfström M, Smithson E. Sense of coherence and psychological outcomes in people with spinal cord injury: Appraisals and behavioural responses. British Journal of Health Psychology. 2010;15(3):611–21. Kennedy P, Lude P, Elfström M, Smithson E. Appraisals, coping and adjustment pre and post SCI rehabilitation: a 2-year follow-up study. Spinal cord. 2012;50(2):112–8. Zerhouni E. The NIH roadmap. American Association for the Advancement of Science; 2003. p. 63–72. Estores IM. The consumer's perspective and the professional literature: what do persons with spinal cord injury want? Journal of Rehabilitation Research & Development. 2003;40(4). Additional Declarations There is no duality of interest Supplementary Files SupplementaryMaterial.pdf Supplementary Material Cite Share Download PDF Status: Published Journal Publication published 09 Apr, 2026 Read the published version in Spinal Cord → Version 1 posted Editorial decision: revise 30 Sep, 2025 Review # 2 received at journal 27 Sep, 2025 Reviewer # 2 agreed at journal 05 Sep, 2025 Review # 1 received at journal 28 Jul, 2025 Reviewer # 1 agreed at journal 23 Jul, 2025 Reviewers invited by journal 22 Jul, 2025 Editor assigned by journal 18 Jul, 2025 Submission checks completed at journal 16 Jul, 2025 First submitted to journal 15 Jul, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7132035","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":489204013,"identity":"a710f029-d2fb-47e4-b359-1613083348c4","order_by":0,"name":"Beatrice Ugiliweneza","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABS0lEQVRIie2QMWuDQBTHXwjoIrheCTVf4YlDKkj6VU4EszjYLVsMQrJIu7ZTv4If4YqQLC7dhA5JEJolg6FLoIH0Lo0lEbsX6m843v3f+/G4A2ho+IPg2QlseSqg8AGkY+KLK60oreBHoaei9Ygn5TupUUrKVlsp19UoPTlc50O/rwEZvDLqJ1pPnq4+LLTsezXV+RYLVNnDM8WMZvo4RccA4vl8IDHMiDkdD117QjzkiQtX0eZcwYzq4wCZHRCP8oE3O84o40rCFUkkCZ+52IKL9VYoo1IZxYtV+HkjFHUmkgPcVpRMOW6h/C1MKBSzttQBoYAjEgZIKm/x7p4CdPSJshFfetDj1JXMCF1jQo6Ko5D03b/4sXm8Dfb9rioP8qLYu12cz/NsN7Sunx9ewqIY9jV16sRQgwQK1uUASn0skJe/9xoaGhr+NV+SmoaGzoHdJAAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0000-0001-7334-6924","institution":"University of Louisville","correspondingAuthor":true,"prefix":"","firstName":"Beatrice","middleName":"","lastName":"Ugiliweneza","suffix":""},{"id":489204014,"identity":"c8b92efd-07cc-40e2-98f0-028694873107","order_by":1,"name":"Elsa Alvarez-Madrid","email":"","orcid":"https://orcid.org/0000-0002-1051-6794","institution":"University of Louisville","correspondingAuthor":false,"prefix":"","firstName":"Elsa","middleName":"","lastName":"Alvarez-Madrid","suffix":""},{"id":489204015,"identity":"8e37c4b4-b0dd-4d25-8d2f-c3a47db58f1a","order_by":2,"name":"April Herrity","email":"","orcid":"","institution":"University of Louisville","correspondingAuthor":false,"prefix":"","firstName":"April","middleName":"","lastName":"Herrity","suffix":""},{"id":489204016,"identity":"e7569375-01d8-4ea8-85ff-b638e309c17d","order_by":3,"name":"Carla Rich","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Carla","middleName":"","lastName":"Rich","suffix":""},{"id":489204017,"identity":"c8230b7c-f73b-4a05-9f16-de7874b2feba","order_by":4,"name":"Kyle Brothers","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Kyle","middleName":"","lastName":"Brothers","suffix":""},{"id":489204018,"identity":"47775044-69c4-4d2a-8998-69250d433132","order_by":5,"name":"Susan Harkema","email":"","orcid":"","institution":"Kessler Rehabilitation","correspondingAuthor":false,"prefix":"","firstName":"Susan","middleName":"","lastName":"Harkema","suffix":""},{"id":489204019,"identity":"ca216441-12d8-4a42-8df5-42ced670c068","order_by":6,"name":"Charles Hubscher","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Charles","middleName":"","lastName":"Hubscher","suffix":""}],"badges":[],"createdAt":"2025-07-15 15:15:56","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7132035/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7132035/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41393-026-01197-y","type":"published","date":"2026-04-09T04:00:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":87720552,"identity":"c723f723-668b-460f-a8fe-5642ac568ae5","added_by":"auto","created_at":"2025-07-28 09:48:18","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":534198,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eClinical Trial Design\u003c/strong\u003e.\u003cstrong\u003e \u003c/strong\u003eFollowing enrollment, individuals and their caregivers completed the first semi-structured interview. After implantation, individuals were randomized into one of four groups. All completed two training timepoints of 80 sessions each. CV-scES: targeted cardiovascular spinal cord epidural stimulation; Vol-scES: targeted voluntary movement spinal cord epidural stimulation; Stand-scES: targeted standing spinal cord epidural stimulation; Stand ABRT: Standing activity-based recovery training.\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-7132035/v1/32816f5a1fc3b64690aa129a.png"},{"id":87721943,"identity":"8f0aef74-c706-4152-8c6d-0fe39ccc03ee","added_by":"auto","created_at":"2025-07-28 09:56:18","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":131641,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eMotivation for Enrolling in Study. \u003c/strong\u003eDedoose Software was used to extract the total number of excerpts to be analyzed. Four major themes were identified and extracted. n: number of excerpts.\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-7132035/v1/756e9a39b20006dfc206bd99.png"},{"id":87720562,"identity":"c1b35d34-5309-4720-85e4-cde6c323cebc","added_by":"auto","created_at":"2025-07-28 09:48:18","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":151128,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eRates of identified themes. \u003c/strong\u003eThe graph presents the percentages for each of the identified themes that were mentioned by participants during the semi-structured interview.\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-7132035/v1/bd036269813faf9ee9e78638.png"},{"id":106490082,"identity":"30ae5f6f-11f3-457e-9b35-65669e0b36f7","added_by":"auto","created_at":"2026-04-09 07:16:34","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1650023,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7132035/v1/6e3506bd-15cc-4e35-b7b8-214d021a4eb0.pdf"},{"id":87721946,"identity":"7126cd60-9b76-4cec-b936-ae5ad72a3298","added_by":"auto","created_at":"2025-07-28 09:56:18","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":444889,"visible":true,"origin":"","legend":"Supplementary Material","description":"","filename":"SupplementaryMaterial.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7132035/v1/f3b08e680e8c48aefc91bc03.pdf"}],"financialInterests":"There is no duality of interest","formattedTitle":"Motivations for participation in a spinal cord epidural stimulation study: Perspectives of individuals with spinal cord injury and their caregivers","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe most recent estimate of Spinal Cord Injury (SCI) in 2024, is an annual incidence of approximately 18,000 new cases each year in the United States (US), with a total prevalence around 305,000 individuals living with this injury(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). SCI directly impacts the normal physiology of the body, causing dysfunction of the neurologic, cardiovascular, respiratory, digestive, and genital-urinary systems. Secondary to these physiological changes, the quality of life and psychosocial areas are also impacted on these individuals and their close relationships. Individuals with SCI are frequently cared for by family members. The assistance required can range from physical tasks – such as bowel and bladder management- to support with activities of daily living, financial management, decision-making and coordination of care(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). The daily time commitment and emotional stress of providing long-term care for a loved one have consistently shown in literature to negatively impact caregiver’s health and quality of life, primarily due to increased physical, emotional, and financial burden(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eSpinal cord epidural stimulation (scES), FDA-approved for pain management, has been investigated and shown promise for improving cardiovascular(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e), motor(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e), bowel and bladder(\u003cspan additionalcitationids=\"CR7\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e–\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) function and improving quality of life in SCI. Although scES requires surgical implantation of a device into the spinal cord, ongoing research continues to investigate its therapeutic potential for SCI. Currently, only a limited number of research centers perform translational studies, and participation often requires relocation, uprooting the individual and, their caregivers from their community, and a commitment to an intense daily rehabilitation program regimen. Individuals who consent to participate in clinical trials often misunderstand the purpose of research interventions that include a clinical care component. This confusion, known as “therapeutic misconception”(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) was first identified decades ago and refers to the mistaken belief that the primary goal of clinical research is to provide therapeutic benefit to participants, rather than to generate generalizable knowledge. While both clinical care and clinical research can positively impact specific populations, their goals are fundamentally different, while the goal of clinical care is to offer an individualized approach for patients, considering their specific needs and prioritizing their well-being. In contrast, clinical research is focused on discovering new knowledge that may benefit a population with the same condition. The effects of therapeutic misconception could be perceived as something positive to enrollment rates; however, it could have a negative impact by not meeting the participant’s expectations, resulting in increased study dropout and overall resentment with the research process(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Moreover, participants and their caregivers often agree to participate in research for conditional altruism(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e), referring to the willingness to help others, but that is unlikely to lead to trial participation unless there is a personal gain(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). The high hopes for the possibility of neurological benefits and recovery could also lead to higher tolerance of risks related to participating in experimental studies(\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Furthermore, hopes on improving function could be translated into less caregiver reliance(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e), potentially adding to the willingness of both, individuals with SCI and their caregivers, to participate in clinical research.\u003c/p\u003e\u003cp\u003eClinical trials, such as the scES study, are the based on finding treatment alternatives for SCI. Despite the advances offered on scientific and medical knowledge, trials often suffer from poor enrollment which yields limited useful knowledge for patients(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). Although some studies have investigated motivators of research participation, many rely on structured methods and are designed to describe the likelihood of participation(\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) with results varying depending on country(\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e), type of study(\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e), and disease related population. Even though studies evaluating participation among individuals with SCI are insightful, they are primarily based on structured surveys with predefined response options, limiting the ability to investigate deeper perceptions and experiences. Currently, the motivation for individuals with SCI to participate in a study involving an invasive procedure remains understudied. The aim of this study was to explore the motivations and expectations driving the decision of people with SCI to participate in a scES study and to understand caregiver perception. This knowledge could help address expectations during the consent process, and create engagement strategies and tools for future studies, prioritizing the most important needs and interests in the population living with SCI.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eThis study assessed pre-intervention data from 18 individuals with chronic cervical spinal cord injury. Participants were enrolled in the study “T\u003cem\u003eargeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury\u003c/em\u003e”, hereafter referred to as “Bowel function study”. The Bowel function study was an ancillary or “piggy-back” study, recruiting participants who were already enrolled in an on-going study, sponsored by the Christopher and Dana Reeve Foundation and The Leona M. and Harry B. Helmsley Charitable Trust, within the epidural SCI research program at our research institution (“\u003cem\u003eTask and physiological specific stimulation for recovery of autonomic function, voluntary movement and standing using epidural stimulation and training after severe spinal cord injury\u003c/em\u003e,” TS-EPI, short name).\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eTS-EPI, the parent study\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eParticipants received a spinal cord epidural stimulator implantation over the lumbosacral cord. After implantation, they were randomized into four groups. All groups received two training interventions of 80 sessions each; at least one training intervention that included spinal cord epidural stimulation targeted for standing with activity-based recovery training (Stand-ABRT). All groups received targeted cardiovascular spinal cord epidural stimulation (CV-scES) or targeted voluntary movement of spinal cord epidural stimulation (Vol-scES), (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The study included five timepoint assessments; (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) pre-training, (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) after 80 sessions of training, (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) after 160 sessions of training, and at the (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) 6- and (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) 12-month follow-up time points. Clinical trial results will be published in a subsequent publication.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eThe Bowel Function study\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eAssessed bowel-related outcomes to evaluate the potential neuromodulatory effects of scES. The study assessed whether scES, targeted for regulating blood pressure, could improve bowel motility and decrease episodes of autonomic dysreflexia during a bowel program. Additionally, assessed whether scES used for activating the trunk and core could improve bowel evacuation by enhancing awareness of rectal fullness and improving the coordination of internal and external sphincter dynamics. Lastly, through qualitative methods, it assessed if alterations in bowel function were associated with quality-of-life improvements.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eThe Current Project\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eThis study is a secondary analysis of the qualitative portion of the Bowel Function study. Data were collected through semi-structured telephone interviews with participants and caregivers at enrollment in the TS-EPI study. The interview guides were designed to elicit participants and their caregivers' perspectives of changes associated with scES. Two different guides were created, one specific for participants and a second for caregivers’ experience. For this study, we included domains related to how participants enrolled in the program; what motivated them to enroll, if they encountered barriers or challenges to seeking the program, if they had tried other therapies, and what they expected the program to provide that they didn’t have found so far. Domains included in the caregiver’s guide included what they knew about the participants' motives to enroll and what they were expecting this program would provide to the participants. Caregiver and participant interviews were conducted separately to encourage candid and independent responses. The interviews were led by personnel with experience conducting open-ended, semi-structured interviews and who were not involved in study operations or data collection. Interviews were evaluated until no new insights were emerging (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). Discussion guides are included as \u003cb\u003eSupplementary Material Appendix 1 and 2\u003c/b\u003e. Audio recordings were transcribed from voice to text by two independent researchers. A third member of the research team reviewed the transcribed text to make sure it was accurate.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eData analysis\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eQualitative analysis was conducted with a thematic analysis approach(\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e) to evaluate participant and caregiver experiences and perspectives of improvement in bowel function. Dedoose, qualitative software, was used to organize and analyze data. Qualitative coding was characterized by a combination of deductive and inductive approaches and proceeded in two rounds. In the first round, three different researchers generated a codebook individually from the domains utilized in the discussion guide. Additional codes were added inductively through an iterative process of initial coding. The team discussed the proposed codes, and two rounds of coding were made to ensure the revised coding scheme was applied uniformly. Every transcript was coded by one member of the team and reviewed for accuracy and completeness by a second member. All inconsistencies were then discussed to clarify the coding scheme and resolve inconsistencies. For this study, we extracted excerpts coded under “Motivation for Enrolling in the study”. This included those coded under subthemes “Gain independence,” “Gain improvement in function,” “Benevolence” and “Other.” For dissemination purposes, excerpts were edited to remove identifying information, and for clarity if this could be accomplished without removing meaning. For example, some filler words and phrases were removed.” The full excerpts are included in \u003cb\u003eSupplementary Appendix 3.\u003c/b\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eEthical considerations\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eParticipants were enrolled in the TS-EPI study, IRB #16.0179, at the Kentucky Spinal Cord Injury Research Center (KSCIRC) at the University of Louisville (UofL) and were required to sign an additional informed consent for participation in the bowel function study, IRB #19.0435.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cb\u003eParticipant Characteristics\u003c/b\u003e: A total of 18 individuals with SCI and 5 caregivers (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) were enrolled (40\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;10 years old, 12\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;10 years since injury, 44.4% males, all cervical, ASIA Impairment Scale (AIS): 39% A, 39% B, 22% C). Most caregivers were participants\u0026rsquo; mothers (60%), followed by fathers (20%) and partner/spouses (20%) (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eDemographic and clinical characteristics\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePub ID\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAge (yrs)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eGender\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eLevel of Injury\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eAIS\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eTime\u003c/p\u003e\u003cp\u003esince\u003c/p\u003e\u003cp\u003einjury\u003c/p\u003e\u003cp\u003e (yrs)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eA64\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e58\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e41\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eB42\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e60\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eC\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e9\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eA97\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e40\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e16\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eB38\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e24\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eB\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eA102\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e31\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e7\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eB45\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e37\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eB\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e11\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eB40\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e37\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eB\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eB52\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e54\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eB\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e10\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eA119\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e28\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e13\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eA128\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e40\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e10\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eA127\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e42\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e14\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eA133\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e36\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e14\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eB194\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e39\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eC\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e20\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eB192\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e43\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eB\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e29\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eC193\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e42\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eC\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e9\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eB212\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e48\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eB\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e30\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eB213\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eB\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e6\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eC237\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e42\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eC4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eC\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"6\"\u003e\u003cb\u003ePub ID\u003c/b\u003e: Publication ID; \u003cb\u003eAIS\u003c/b\u003e: American Spinal Injury Association Impairment Scale.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eDemographics of caregivers \u003cb\u003eCG\u003c/b\u003e: Caregiver.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePub ID\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRelationship\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAge\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eRace/Ethnicity\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eB38 CG\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMother\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e49\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNon-Hispanic/Latino\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eA102 CG\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMother\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e59\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eWhite\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eA127 CG\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMother\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e60\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eHispanic/Latino\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eB42 CG\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSpouse\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e56\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eWhite\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eB40 CG\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eFather\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e65\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eCaucasian/White\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMotivations for enrolling in the epidural stimulation study\u003c/strong\u003e\u003cp\u003eWe conducted 23 semi-structured interviews with participants and their caregivers at the time of enrollment. 94% of participants (N\u0026thinsp;=\u0026thinsp;17) mentioned a motivator to enroll. 85 excerpts themed under \u0026ldquo;Motivation for Enrollment in the Study\u0026rdquo; were extracted and analyzed (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Most of the excerpts were coded with more than one code (\u003cb\u003eSupplemental Table\u0026nbsp;1\u003c/b\u003e). Emergent themes showed that 78% enrolled in the study hoping to have improvements in function, 72% to gain independence, 28% for benevolence, and 44% mentioned other reasons. All caregivers expressed hopes for function improvements; 60% were hoping for more independence, and 40% for benevolence (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eInterview Findings\u003c/b\u003e (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eExamples of excerpts extracted from Dedoose Software under \u0026ldquo;Motivation for Enrolling in Study\u0026rdquo;.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTheme\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eExcerpt Examples\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"5\" rowspan=\"6\"\u003e\u003cp\u003eImprovements in Function\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;I look at this research as potentially life extending and if it can improve my autonomic functions such as normalizing blood pressure or improving the bowel or bladder activity, that would be an unbelievable success\u0026rdquo; (\u003cem\u003ePub ID A64\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;The idea of being able to regulate my blood pressure was a big thing (...) having a device that works to regulate my blood pressure, depending on what activity is going on, that\u0026rsquo;s what really interested me\u0026rdquo; (\u003cem\u003ePub ID A97\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;If I could regain control over my bowel and bladder, that would be fantastic\u0026rdquo; (\u003cem\u003ePub ID C237\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;You want it all, but you are going to be happy wherever you get. (...) as far as bowel and bladder; it would be amazing to not have to use enema\u0026rdquo; (\u003cem\u003ePub ID B192\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;I'm going to see what happens and hope for the best but also be cautious with my optimism (...)\u0026nbsp;anything I gain is going to be something that I wasn't going to get back home (\u003cem\u003ePub ID C237\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;I thought that if it could improve anything,\u0026nbsp;why not go for it?\u0026nbsp;I have everything to gain but nothing to lose\u0026rdquo; (Pub ID B192).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"6\" rowspan=\"7\"\u003e\u003cp\u003eGain Independence\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;I would like to be able to stand. I don\u0026rsquo;t need to run a marathon. If I could stand up and adjust myself in the chair\u0026rdquo; (Pub ID B42).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;I would love to be able to pee when I want to, from how it should be not from having this tube\u0026rdquo; (Pub ID B213).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;Even if I can stand without having necessarily a standing wheelchair would be huge, just to be able to reach things, instead I have to spend 15\u0026ndash;20 minutes looking for somebody to help me reach something (\u0026hellip;) to be able to cook, or do different things around the house, or make it easier to go shopping\u0026rdquo; (\u003cem\u003ePub ID C237\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eI want to better my life, become more independent and be healthier (...) I want to improve every function, if that includes bowels, then I want to do it (\u003cem\u003ePub ID B194\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;We are hoping that it will give a little bit more freedom. I\u0026rsquo;m not saying to go jump up and run the Boston Marathon, but if this program could help to get bowel and bladder function back, even just stand up enough to adjust so he\u0026rsquo;s comfortable and doesn\u0026rsquo;t have to rely on someone to do it\u0026rdquo; (Pub ID B42 CG).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ementioned \u0026ldquo;I wish my bowels would start working again to where I could do more of it on my own (...) I could save her a whole lot of wear and tear on her knees\u0026rdquo; (\u003cem\u003ePub ID B42\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;For the study, the goal (...): however, I can find ways to regain function to limit the needs I have with caregiving\u0026rdquo; (Pub ID A133).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eBenevolence\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;I want to try and help advance the research. If you thought about the polio community, they came up with a vaccine for polio, they eradicated polio, but they forgot about those who were already paralyzed by polio (...) I don\u0026rsquo;t want that to happen to this field (Pub ID A64).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;She has to do this now to reach the end goal, not only for her, but for everyone else in the community. If she doesn\u0026rsquo;t do it and the next person doesn\u0026rsquo;t want to do it- you\u0026rsquo;re not going to move forward as a whole\u0026rdquo; (\u003cem\u003ePub ID A102\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e\u003cp\u003eOther\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;Seeing proof of the benefit\u0026rdquo; though previous participants, was very compelling (\u003cem\u003ePub ID A64\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;I\u0026rsquo;ve spoken to a lot of people who\u0026rsquo;ve gone through it; most people have had improvements one way or the other, but they\u0026rsquo;re not all walking out of the lab. But I do look at and define a \u0026ldquo;cure\u0026rdquo; as any degree of improvement\u0026rdquo; (\u003cem\u003ePub ID A64\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;Better overall health, anything that can improve your longevity or improve your quality of life whatever that may be to you as an individual\u0026rdquo; (\u003cem\u003ePub ID B192\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ldquo;That it was sponsored, paid for, or whatever by the Christopher Reeve Foundation. I figured anything they have been involved in was probably pretty legit\u0026rdquo; (\u003cem\u003ePub ID B212\u003c/em\u003e).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eImprovements in Function\u003c/b\u003e\u003c/p\u003e\u003cp\u003eTo gain improvement in function was the most prevalent theme. Most of the participants who enrolled into the epidural stimulation study were hoping to have improvements in function, with most citing functions such as bowel, bladder, sexual, cardiovascular, and thermoregulation, but also motor functions such as hands and fingers control, trunk and leg muscle strength, voluntary movement, and standing. Although most participants expressed hope for functional improvements, they remained cautious with their hopes and optimism. Still, they believed that participating in the study offered a better chance of improvement than staying home. Overall, the potential for personal benefit related to function was more perceived as beneficial rather than a risk.\u003c/p\u003e\u003cp\u003e\u003cb\u003eGain Independence\u003c/b\u003e\u003c/p\u003e\u003cp\u003eHopes for more independence were expressed as \u0026ldquo;\u003cem\u003ea little bit more freedom\u0026rdquo;\u003c/em\u003e to \u003cem\u003e\u0026ldquo;experience the world a little bit more.\u0026rdquo;\u003c/em\u003e Consistently, the hopes to gain more function such as standing, walking, bowel and bladder function, and transfer, were related to being more independent and being able to perform activities of daily living on their own and reduce the amount of time invested. They expressed wishes to adjust themselves in the wheelchair and to urinate without the support of a urinary catheter. Improvements in bowel and bladder function were mentioned as gaining independence; \u0026ldquo;I would like to do it on my own,\u0026rdquo; \u0026ldquo;when I want to,\u0026rdquo; and \u0026ldquo;\u003cem\u003ehow it is supposed to be\u003c/em\u003e\u0026rdquo;. Caregivers mentioned they were hoping this study would give them a \u0026ldquo;little bit of freedom\u0026rdquo; by improving participant\u0026rsquo;s bowel and bladder function. Participants expressed hopes that improved function and greater independence would lessen caregiver burden and enhance their relationship -particularly when caregivers were close personal relationships. Even small functional gains were expected to reduce the time caregivers needed to provide support.\u003c/p\u003e\u003cp\u003e\u003cb\u003eBenevolence\u003c/b\u003e\u003c/p\u003e\u003cp\u003eEven if there was no change at the end of the study, participants and caregivers believed that it was important to participate for \u0026ldquo;Benevolence\u0026rdquo;, to researchers learn from them to contribute to the advancement of research in the field of SCI and potentially help people in the future. Contributing knowledge for the community with SCI, was described as the \u0026ldquo;end goal\u0026rdquo;. One of their concerns was that the research field forgot about those who have chronic SCI, and there were no advancements. Participants were also aware this study was experimental and the reason they participated was to help other individuals. Additionally, caregivers were motivated to participate in clinical trials to \u0026ldquo;reach the end goal\u0026rdquo;, not for personal benefit but to help the SCI community \u0026ldquo;to move forward as a whole\u0026rdquo;.\u003c/p\u003e\u003cp\u003e\u003cb\u003eOther reasons to enroll\u003c/b\u003e\u003c/p\u003e\u003cp\u003eExperiences from other participants motivated some individuals with SCI to enroll, regardless of being integrated in the community, having a job and their own business. \u0026ldquo;\u003cem\u003eSeeing proof of the benefit\u003c/em\u003e\u0026rdquo; though previous participants, was very compelling. They mentioned being aware that \u0026ldquo;\u003cem\u003ewalking out of the lab\u003c/em\u003e\u0026rdquo; was not the experience of other participants, but \u0026ldquo;\u003cem\u003ecure\u003c/em\u003e\u0026rdquo; was any degree of improvement. Additionally, they enrolled hoping to improve their quality of life by improving function, overall health, longevity, and independence. Lastly, they relied on the sponsors reputation to enroll.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOur findings suggest that the main motivator for an individual with SCI to enroll in a scES study is to improve function (78%) and gain independence (72%) to ease caregivers\u0026rsquo; burden. Those who mentioned enrolling for benevolence (23%), were hoping for researchers to learn from them to help the community with SCI. Almost a half of the participants (44%) mentioned other reasons such as: improving quality of life and overall health, as well as being motivated by previous participants experiences.\u003c/p\u003e\u003cp\u003eFunction improvements, mentioned by 78% of the participants, was the main motivator for individuals with SCI to enroll into a clinical study. Improvements in motor, cardiovascular, bowel and bladder function, and core strength were repeatedly cited. Cardiovascular function was mentioned as hope to control blood pressure. Regarding bowel and bladder function, they were hoping for full recovery someday, but an increase in sensation was a goal for the TS-EPI study. They were wishing for improved core strength, to be able to be seated straight in their chair or not be scared to falling during transfers. Some of them defined \u003cem\u003ethe cure\u003c/em\u003e as \u0026ldquo;whatever improvement they could have.\u0026rdquo; Individuals with SCI expressed they were not hoping to walk again or run a marathon out of the study; but whatever improvement they had was worthwhile recovery. This finding is consistent with a multi-national survey study(\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e), which found that \u0026ldquo;improvement in functionality\u0026rdquo; was the number one facilitator for individuals with SCI to participate in a clinical study. Another study investigating functional priorities in persons with SCI, 44\u0026ndash;76% of participants with cervical injuries were more likely to choose arm/hand function over other functions such as walking, bladder/bowel control, sexual function, and relief of pain(\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). While priority in improving function was expected based on previous literature(\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e), our findings offer a deeper insight into the perspectives and functional concerns of individuals with SCI.\u003c/p\u003e\u003cp\u003eFunctional improvements were frequently related to gaining independence; 72% of participants were hoping to be more independent out of the study to reduce the workload on their caregivers, to be able to do more things at home, and to experience life more. They expressed that by improving their bladder and bowel functions and muscle strength, they would be able to do more things on their own. Core strength was continually mentioned to be able to sit up on their own, and to have more balance for better use of their wheelchair. Independence was mentioned as doing activities of daily living; reaching things without help and being able to transfer. Improvements in care and rehabilitation have resulted in an increased population living with SCI. Secondary to this increase, individuals with chronic disabilities and researchers have shifted focus to independence, participation, and autonomy(\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). Our findings shed light on the meaning of regaining function and independence for individuals with SCI; since many of them mentioned they would like to be more independent to reduce the work on their caregivers. Whereas social support has been previously related to better health, functioning, and well-being(\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e), reciprocity -where the individual with SCI can help the caregiver in other aspects- is a crucial factor for healthy support between family or marital relationships with an individual with SCI(\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). Continuing research on function improvements that can help individuals with chronic SCI have an independent life should be the focus of current and future investigations. Additionally, including caregiver education in clinical trials could be beneficial for both individuals to reduce the strain in the relationship, particularly in long-term studies where caregiving demands tend to be higher.\u003c/p\u003e\u003cp\u003eFurthermore, participants enrolled hoping to improve their quality of life; they expected that by improving function, independence, and overall health, they could reach this goal. A recent study by Roth et al.(\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e), showed that, in individuals with chronic SCI, perspectives of quality of life vary depending on the time since injury; recovery is most important for those with 1\u0026ndash;5 years of injury, navigating the community and handing difficult situations for those with 5\u0026ndash;15 years of injury, and self-reflection and handling challenges positively for those with more than 15 years of injury. In our study, two of the participants hoped to improve quality of life by improving function and independence, both with 9 years since injury. However, another participant with 29 years since injury who enrolled to improve quality of life was hoping to have better health and longevity. Several studies have shown that quality of life is not strongly influenced by physical variables(\u003cspan additionalcitationids=\"CR30\" citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). In contrast, personal characteristics such as positive emotions(\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e), optimism(\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e), hope(\u003cspan additionalcitationids=\"CR33\" citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e), coherence(\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e), and psychological dynamics, as coping strategies(\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e), can improve and predict quality of life over time. Providing psychological and educational support during long clinical trials may enhance participants\u0026rsquo; quality of life, improve their overall experience, and help align outcomes with study expectations.\u003c/p\u003e\u003cp\u003eThose who enrolled in the study for benevolence (28%), mentioned that being part of scientific research breakthroughs was important to them, regardless of having function back. This is different from other populations(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e), where benevolence was conditioned into having function back or an economic gain. The difference in their response may be attributed to individuals with chronic SCI having been told repeatedly that recovery is not possible. They have learned to \u0026ldquo;manage their expectations\u0026rdquo; and consider being part of research for the greater good. However, the hopes for improvement were expressed most of the time.\u003c/p\u003e\u003cp\u003eIndividuals' participation in research has been acknowledged for some time now(\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e) whereas there are recent survey studies regarding facilitators, barriers(\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) and priorities(\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e) of individuals with SCI, the overall response to participate in clinical trials remains low, especially when it involves a procedure, and the risks are explained. This study gives us an insight into what was meaningful to individuals with SCI who were enrolled in a clinical study that included an invasive procedure. The knowledge obtained from this study could help future researchers design clinical trials in a way that cover the main concerns of the population with SCI. Additionally, this knowledge should encourage researchers to continue studying questions that improve function of individuals with SCI focused on gaining independence, with the premise that \u0026ldquo;cure or recovery is whatever improvement they can have\u0026rdquo;, whereas we continue working towards recovering total function, having an improvement in bowel, urinary, cardiovascular or motor function, could be highly meaningful to them working as a motivator to participate in clinical trials and contribute to scientific breakthroughs.\u003c/p\u003e\u003cp\u003e\u003cb\u003eStrength and Limitations\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis study's strength is based on the focus of integrating the participant and caregiver\u0026rsquo;s insight into a quantitative study. Qualitative studies provide detailed insight about a specific topic; with semi-structured interviews, it is more likely to garner detailed responses; they provide the flexibility to ask clarifying questions and probe deeper into responses. While providing rich detail in participants and caregiver experiences could help inform future developments, there were a few limitations. This study may not be representative of the SCI population and may be limited due to the likelihood that a certain type of participant with a particular viewpoint, elected to take part in this study. Another limitation is that this study is only evaluating the enrollment period and does not cover post-training interviews and met expectations after the study were not assessed. However, this is planned as part of a future study. Despite limitations, semi-structured interviews help us to listen to participants\u0026rsquo; perspectives and thoughts which should always be considered at the time of planning clinical trials. Considering their needs is crucial to enhance research practice.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003ePeople with SCI and their caregivers participate in scES research studies with a sense of cautious hope to improve function. Their wishes to recover function was tightly related to gain independence and reduce work to family and caregivers. Most importantly, regardless of not gaining anything back, they want to at least play a part in scientific breakthroughs aimed at helping the next person with injury live an easier life and with better quality. This knowledge can help to create future research questions that are meaningful to individuals with SCI and to optimize future clinical trials considering what is important for this population.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgments:\u003c/strong\u003e We are indebted to our research participants for their courage, dedication, motivation, and perseverance that made these research findings possible. Drs. Jonathan Hodes and Maxwell Boakye performed surgical implantation and provided medical oversight. Drs. Douglas Stevens, Glen Hirsch, Darryl Kaelin, and Sarah Wagers provided medical oversight. Yukishia Austin, Lynn Robbins, and Kristen Johnson provided medical management. We would like to thank Dr. Yangsheng Chen for engineering leadership, Taylor Blades, and Christie Ferreira for project management. Rebekah Morton, Matthew Green, Paul Criscola, Justin Vogt, Katie Pfost, Katelyn Brockman, Brittany Logdson, Ricky Seither, Kristin Benton, Dylan Pfost, and Joseph Carrico led research interventions and provided support for research participants. We would also like to thank Riley Wilkinson, Ashley Ezzo, Dengzhi Wang, and Erin Wyles for voice to text transcription.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e: \u003cstrong\u003eConceptualization\u003c/strong\u003e: BU, AH. \u003cstrong\u003ePlanning:\u003c/strong\u003e AH, BU, CH, SH. \u003cstrong\u003eInvestigation:\u003c/strong\u003e AH, BU, EA, CR. \u003cstrong\u003eMethodology:\u0026nbsp;\u003c/strong\u003eAH, BU, KY, CR. \u003cstrong\u003eProject Administration:\u0026nbsp;\u003c/strong\u003eEA. \u003cstrong\u003eWriting Original Draft:\u003c/strong\u003e EA, BU.\u003cstrong\u003e\u0026nbsp;Validation:\u0026nbsp;\u003c/strong\u003eEA, BU, AH, SH, CH. \u003cstrong\u003eVisualization:\u003c/strong\u003e EA, BU. \u003cstrong\u003eWriting \u0026ndash; Review and Editing:\u003c/strong\u003e EA, AH, CR, KB, SH, CH, BU.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e: This work was funded by DoD (W81XWH-19-1-0734). The parent study was funded by Christopher and Dana Reeve Foundation, Leona M. \u0026amp; Harry B. Helmsley Charitable Trust, and Medtronic Plc for spinal cord epidural stimulation implants. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests:\u003c/strong\u003e The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability statement\u003c/strong\u003e: Data available within the published study and its supplementary files. Additional data are available from the corresponding author on reasonable request.\u003cstrong\u003e\u003cbr\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eCenter NSCIS. Traumatic Spinal Cord Injury Facts and Figures at a Glance. 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Trials 2010 11:1. 2010;11(1).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKwon BK, Ghag A, Dvorak MF, Tetzlaff W, Illes J. Expectations of benefit and tolerance to risk of individuals with spinal cord injury regarding potential participation in clinical trials. Journal of neurotrauma. 2012;29(18):2727\u0026ndash;37.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eThorogood NP, Waheed Z, Chernesky J, Burkhart I, Smith J, Sweeney S, et al. Spinal cord injury community personal opinions and perspectives on spinal cord stimulation. Topics in Spinal Cord Injury Rehabilitation. 2023;29(2):1\u0026ndash;11.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHefele B, Langan SM, Pollins K, Gelfand JM. Engaging the Patient\u0026rsquo;s Perspective in Clinical Trials Research. The Journal of Investigative Dermatology. 2019;139(6).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAnderson KD, Cowan RE, Horsewell J. Facilitators and barriers to spinal cord injury clinical trial participation: multi-national perspective of people living with spinal cord injury. Journal of neurotrauma. 2016;33(5):493\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBahsoun S, Kuiper J-H, Hulme CH, Twigg AJA, El Masri W, Glass C, et al. Evaluating patient perspectives on participating in scientific research and clinical trials for the treatment of spinal cord injury. Scientific Reports. 2021;11(1):4361.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNappo SA, Iafrate GB, Sanchez ZM, Nappo SA, Iafrate GB, Sanchez ZM. Motives for participating in a clinical research trial: a pilot study in Brazil. BMC Public Health 2013 13:1. 2013;13(1).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSoule MC, Beale EE, Suarez L, Beach SR, Mastromauro CA, Celano CM, et al. Understanding motivations to participate in an observational research study: Why do patients enroll? Social Work in Health Care. 2016;55(3).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eStarks H, Brown Trinidad S. Choose your method: A comparison of phenomenology, discourse analysis, and grounded theory. Qualitative health research. 2007;17(10):1372\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSaunders B, Sim J, Kingstone T, Baker S, Waterfield J, Bartlam B, et al. Saturation in qualitative research: exploring its conceptualization and operationalization. Quality \u0026amp; quantity. 2018;52:1893\u0026ndash;907.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMiles MB, \u0026amp; Huberman, A. M. Qualitative data analysis: An expanded sourcebook (2nd ed.): Sage Publications, Inc.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLo C, Tran Y, Anderson K, Craig A, Middleton J. Functional priorities in persons with spinal cord injury: using discrete choice experiments to determine preferences. Journal of neurotrauma. 2016;33(21):1958\u0026ndash;68.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAnderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004;21(10):1371\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLili L, Sunnerhagen KS, Rekand T, Alt Murphy M. Participation and autonomy, independence in activities of daily living and upper extremity functioning in individuals with spinal cord injury. Scientific Reports. 2024;14(1):9120.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eM\u0026uuml;ller R, Peter C, Cieza A, Geyh S. The role of social support and social skills in people with spinal cord injury\u0026mdash;a systematic review of the literature. Spinal cord. 2012;50(2):94\u0026ndash;106.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLe Fort M, Lef\u0026egrave;vre C, Kieny P, Perrouin-Verbe B, Ravaud J-F. The functioning of social support in long-term prevention after spinal cord injury. A qualitative study. Annals of physical and rehabilitation medicine. 2021;64(4):101454.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRoth EJ, Lovell L, Barry A. Perspectives on factors influencing quality of life in persons with long-term spinal cord injury: a qualitative study. Spinal Cord. 2024:1\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMiddleton J, Tran Y, Craig A. Relationship between quality of life and self-efficacy in persons with spinal cord injuries. Archives of physical medicine and rehabilitation. 2007;88(12):1643\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLidal IB, Veenstra M, Hjeltnes N, Biering-S\u0026oslash;rensen F. Health-related quality of life in persons with long-standing spinal cord injury. Spinal cord. 2008;46(11):710\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCardile D, Calderone A, De Luca R, Corallo F, Quartarone A, Calabr\u0026ograve; RS. The Quality of Life in Patients with Spinal Cord Injury: Assessment and Rehabilitation. Journal of clinical medicine. 2024;13(6):1820.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKortte KB, Gilbert M, Gorman P, Wegener ST. Positive psychological variables in the prediction of life satisfaction after spinal cord injury. Rehabilitation Psychology. 2010;55(1):40.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMortenson W, Noreau L, Miller W. The relationship between and predictors of quality of life after spinal cord injury at 3 and 15 months after discharge. Spinal cord. 2010;48(1):73\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eVan Leeuwen CM, Post MW, Van Asbeck FW, Bongers-Janssen HM, Van Der Woude LH, De Groot S, et al. Life satisfaction in people with spinal cord injury during the first five years after discharge from inpatient rehabilitation. Disability and rehabilitation. 2012;34(1):76\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKennedy P, Lude P, Elfstr\u0026ouml;m M, Smithson E. Sense of coherence and psychological outcomes in people with spinal cord injury: Appraisals and behavioural responses. British Journal of Health Psychology. 2010;15(3):611\u0026ndash;21.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKennedy P, Lude P, Elfstr\u0026ouml;m M, Smithson E. Appraisals, coping and adjustment pre and post SCI rehabilitation: a 2-year follow-up study. Spinal cord. 2012;50(2):112\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eZerhouni E. The NIH roadmap. American Association for the Advancement of Science; 2003. p. 63\u0026ndash;72.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eEstores IM. The consumer's perspective and the professional literature: what do persons with spinal cord injury want? Journal of Rehabilitation Research \u0026amp; Development. 2003;40(4).\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"spinal-cord","isNatureJournal":false,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"sc","sideBox":"Learn more about [Spinal Cord](http://www.nature.com/sc/)","snPcode":"41393","submissionUrl":"https://mts-sc.nature.com/cgi-bin/main.plex","title":"Spinal Cord","twitterHandle":"@journalsci","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Spinal cord injury, epidural stimulation, motivation, perspective, translational trials","lastPublishedDoi":"10.21203/rs.3.rs-7132035/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7132035/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eSTUDY DESIGN: \u003c/strong\u003eQualitative, semi structured interviews.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOBJECTIVES:\u003c/strong\u003e Spinal cord epidural stimulation (scES) has shown promise for improving autonomic and motor function in individuals with spinal cord injury (SCI). Participation on translational studies often requires relocation, uprooting the individual and caregivers from their community. This study aimed to explore the motivations and expectations driving the decision to participate in a scES study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSETTING: \u003c/strong\u003eInterviews were conducted at enrollment in a randomized trial evaluating scES efficacy at the Kentucky Spinal Cord Injury Research Center, University of Louisville, USA.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMETHODS:\u003c/strong\u003e 23 interviews were conducted with 18 individuals with SCI (40\u003cu\u003e+\u003c/u\u003e10 years old, 12\u003cu\u003e+\u003c/u\u003e10 years since injury, 44% males, all cervical, ASIA Impairment Scale: 39% A, 39% B, 22% C) and 5 caregivers. Interviews were audio recorded, transcribed, and analyzed with a thematic approach.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRESULTS:\u003c/strong\u003e Four main themes emerged: gaining independence, improving function, benevolence, and other. Participants and caregivers hoped that improved function would lead to more independence—described as “a little more freedom,” “experience the world,” and to “not rely on someone.” Any change was expressed as improving the quality of life. Many managed their expectations by recognizing the impact of individual characteristics on outcomes. Even if no improvement occurred, participation felt meaningful—motivated by benevolence and a desire to advance SCI research and help others.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONCLUSIONS:\u003c/strong\u003e People with SCI and their caregivers participate in scES research with cautious hope to gain freedom and improve quality of life through improved function. They also aim to help others through advancing science.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSPONSORHIP\u003c/strong\u003e: This work was funded by DoD (W81XWH-19-1-0734). The parent study was funded by Christopher and Dana Reeve Foundation, Leona M. \u0026amp; Harry B. Helmsley Charitable Trust, and Medtronic Plc for spinal cord epidural stimulation implants.\u003c/p\u003e","manuscriptTitle":"Motivations for participation in a spinal cord epidural stimulation study: Perspectives of individuals with spinal cord injury and their caregivers","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-07-28 09:48:13","doi":"10.21203/rs.3.rs-7132035/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"revise","date":"2025-09-30T15:03:41+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"This content is not available.","date":"2025-09-27T20:27:30+00:00","index":2,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2025-09-05T15:44:04+00:00","index":2,"fulltext":"This content is not available."},{"type":"editorInvitedReview","content":"This content is not available.","date":"2025-07-28T15:47:05+00:00","index":1,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2025-07-23T15:15:10+00:00","index":1,"fulltext":"This content is not available."},{"type":"reviewersInvited","content":"","date":"2025-07-22T13:15:29+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-07-18T12:56:19+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-07-16T11:15:42+00:00","index":"","fulltext":""},{"type":"submitted","content":"Spinal Cord","date":"2025-07-15T15:05:32+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"spinal-cord","isNatureJournal":false,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"sc","sideBox":"Learn more about [Spinal Cord](http://www.nature.com/sc/)","snPcode":"41393","submissionUrl":"https://mts-sc.nature.com/cgi-bin/main.plex","title":"Spinal Cord","twitterHandle":"@journalsci","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"78bf435d-3095-49f5-9009-a77460949c22","owner":[],"postedDate":"July 28th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":51936003,"name":"Health sciences/Medical research"},{"id":51936004,"name":"Health sciences/Medical research/Clinical trial design/Randomized controlled trials"}],"tags":[],"updatedAt":"2026-04-09T07:16:25+00:00","versionOfRecord":{"articleIdentity":"rs-7132035","link":"https://doi.org/10.1038/s41393-026-01197-y","journal":{"identity":"spinal-cord","isVorOnly":false,"title":"Spinal Cord"},"publishedOn":"2026-04-09 04:00:00","publishedOnDateReadable":"April 9th, 2026"},"versionCreatedAt":"2025-07-28 09:48:13","video":"","vorDoi":"10.1038/s41393-026-01197-y","vorDoiUrl":"https://doi.org/10.1038/s41393-026-01197-y","workflowStages":[]},"version":"v1","identity":"rs-7132035","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7132035","identity":"rs-7132035","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}