Effectiveness of Sensory Electrical Stimulation Augmented Virtual Reality Training on Sitting Balance and Quality of Life in individuals with Incomplete Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial

Effectiveness of Sensory Electrical Stimulation Augmented Virtual Reality Training on Sitting Balance and Quality of Life in individuals with Incomplete Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Effectiveness of Sensory Electrical Stimulation Augmented Virtual Reality Training on Sitting Balance and Quality of Life in individuals with Incomplete Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial Nikhil Chowdhary, Stuti Khanna, Garima Wadhwa, Shefali Walia This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6213083/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 6 You are reading this latest preprint version Abstract Background : Individuals with incomplete Spinal Cord Injury (iSCI) often face significant impairments in sitting balance and mobility due to trunk instability. These challenges can severely impact functional abilities, participation in daily activities and overall Quality of Life (QoL). Studies have highlighted the potential of virtual reality (VR) training to improve sitting balance in individuals with iSCI. Furthermore, Sensory Electrical Stimulation (SES) has shown positive effects on sitting balance in various neurological populations. However, research exploring the combined effectiveness of VR and SES on sitting balance and QoL specifically within the iSCI human population remains limited. Methodology : This study will be a double-blind parallel, two-group, randomized controlled trial that aims to evaluate the effectiveness of SES augmented VR training on sitting balance and QoL in individuals with iSCI. A total of 22 participants with iSCI, with a neurological level of injury between T6 and T12 will be recruited from the rehabilitation department at the Indian Spinal Injuries Centre, adhering to inclusion criteria. Participants will be randomly assigned to one of two groups using a 1:1 allocation ratio. The intervention group will engage in VR-based balance training along with SES application, while the control group will solely engage in VR-based balance training. Both groups will undergo interventions consisting of 30-minute sessions, five times a week for a duration of 4 weeks. Outcome measures : The assessment of sitting balance will be done using the Modified Functional Reach Test (mFRT) and the Star Test using the Tecnobody Prokin 252 Trunk Sensor. Additionally, the International Spinal Cord Society Quality of Life Basic Data Set (ISCoS QoL BDS) Version 1.0 will be used to measure QoL. Discussion : The effectiveness of the SES augmented VR based balance training program will be evaluated based on the changes in the mFRT, Star Test (Prokin 252 Trunk Sensor) and ISCoS Quality of Life Basic Data Set Version 1.0 following four weeks of intervention. This trial aims to enhance understanding of how SES augmented VR training can improve sitting balance and QoL in individuals with iSCI. Trial Registration : The trial is registered with the Clinical Trials Registry – India on 18 th April 2024 with registration number CTRI/2024/04/065897. Spinal cord injury Sitting balance Quality of life Virtual reality Sensory electrical stimulation Rehabilitation Figures Figure 1 Background Spinal cord injury (SCI) is a debilitating neurological condition which is characterized by sensory, motor, autonomic or bowel dysfunction caused by damage to neuronal elements of the spinal cord. It's incidence ranges from 8 to 246 cases per million worldwide whereas the prevalence ranges from 236 to 1298 per million [ 1 ] with approximately 20,000 new cases documented annually in India [ 2 ]. Notably, countries like India are at high risk with an average age group ranging from 26.8 to 56.6 years with a male-to-female ratio of 4:1 [ 1 ]. It often leads to profound disability that negatively impacts physiological, physical or psychological well-being and restricts employment opportunities even after the individual has reintegrated into community. Following SCI, maintaining sitting balance is essential for performing activities of daily living (ADLs). Approximately 70–80% of individuals with SCI experience impaired or no trunk control, which adversely affects their ability to maintain sitting balance and overall QoL [ 3 ]. Trunk instability is a significant concern for individuals with SCI [ 4 ], as it impacts their ability to perform everyday tasks such as bed movements, unsupported sitting and self-care activities [ 5 ][ 6 ]. Additionally, it can also lead to secondary complications such as pressure sores [ 7 ], spinal deformities [ 8 ] and pulmonary dysfunction [ 5 ]. Furthermore, individuals with SCI are also at a higher risk of falls even during stationary sitting, leading to fall-related pain, bone fractures [ 9 ]. Consequently, QoL in individuals with SCI is closely linked to their dynamic sitting balance and ability to sit unsupported [ 10 ] a relationship that becomes increasingly important over time post-injury [ 8 ]. Given these challenges, recovery of trunk control is essential for those experiencing difficulties with sitting balance [ 11 ]. However, research investigating sitting balance in individuals with iSCI remains limited [ 10 ]. Conventional methods for maintaining sitting stability often involve belts, straps and customized seating adaptations designed to stabilize the trunk and prevent falls while facilitating upper limb function [ 12 ]. Unfortunately, these techniques can restrict dynamic mobility and hinder the ability to reach for objects [ 13 ]. The recovery of sitting balance is a primary objective in rehabilitation programs for individuals with iSCI. While research on effective balance training protocols for individuals with iSCI is scarce, recent advancements and existence of many strategies like Electrical stimulation [ 14 ], Non-Invasive Spinal Stimulation [ 9 ], Community exercise Programme [ 15 ], Functional Electrical Stimulation [ 16 ] and VR [ 17 , 18 ] demonstrates improvement in mobility along with postural control. Methods utilizing VR have demonstrated positive results for training balance across various neurological populations. VR offers the advantage of creating multiple sensory inputs visual, sensory, and auditory feedback through task-specific approaches in a virtual environment that mimics real-world scenarios. This technology provides a user-computer interface that facilitates real-time simulation of activities or environments, allowing user interaction through various sensory modalities and enhancing engagement and motivation during rehabilitation. Previous studies utilizing game-based exercises within VR have shown improvements in dynamic sitting balance among individuals with SCI [ 19 , 20 , 21 ]. SES involves use of low-intensity currents (below, at or only just above the sensory threshold), which do not induce any visible muscle contraction and provides only sensory information. The beneficial effects of SES are thought to occur at the peripheral (sensory receptors sensitivity), spinal (spinal motoneural excitability) and supra-spinal (cortex reorganisation or adaptation) levels. SES appears to be particularly useful to reinforce or restore the postural function in the immediate/ concurrent, acute or chronic application in pathological populations. Studies have already shown that SES is effective at improving postural balance in various neurological conditions such as stroke, cerebral palsy [ 22 , 23 ]. Therefore, this study aims to investigate the effectiveness of SES augmented VR training on sitting balance and QoL in individuals with incomplete SCI. It is hypothesized that significant improvement in sitting balance and QoL will be noticeable after 4 weeks of SES augmented VR training when compared with participants receiving VR training alone. Materials and methods A clinical trial is designed to evaluate the effectiveness of the SES augmented VR based balance Training on sitting balance and QoL in individuals with iSCI. Patient and study design: A double-blind, parallel, two-group, randomized controlled trial with equal subject allocation (1:1) will be undertaken. A purposive sample of 22 participants with iSCI will be recruited from the inpatient and outpatient rehabilitation departments of the Indian Spinal Injuries Centre, New Delhi, India. All participants will be provided with information sheets and written consent will be obtained by the principal investigator before recruitment. The demographic details will be obtained and the participants will be selected based on the eligibility criteria after neurological examination (Table 1). (Enter Table 1) The participants will be randomly assigned to any of the two groups: virtual reality-based balance training + sensory electrical stimulation (VR-SES) group and virtual reality-based balance training (VR) group for five times a week for four weeks. DRRC and RRC of the research department of the Indian Spinal Injuries Centre hold the legal liability and keep the check and record of all potential recruits and monitor the data collection throughout the intervention. The members of DRRC along with the consultants and physiotherapists in the hospital provide day-to-day support to all aspects of the local organization of the trial. The trial is supervised by the guides and co-guides twice a week. This research protocol is consistent with the current Consolidated Standards of Reporting Trials (CONSORT) guidelines (Fig. 1 ) and follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT schedule) (Table 2) [ 24 ] and is developed based on the SPIRIT checklist (Additional document). A visual description of the study regarding enrollment, assessments and interventions is shown in Table 2. Baseline assessments (T 0 ) will be done before group allocation. Post-intervention assessments of both the groups (T 1 ) will be done after 4 weeks of intervention to detect potential long-term effects. (Enter Table 2) (Enter Fig. 1 ) Ethical considerations: The enrolled participants will be informed orally and in writing about the purpose of this trial, its potential risks, benefits of participation and the right to withdraw from the trial at any point during the study. A written informed consent signed by the participants will be taken from those who are willing to participate in the study. The data of the participants will be collected, documented, and managed confidentially using the paper-based entry data sets. Only all the authors related to the trial will have access to the final trial dataset. The masked datasets analyzed during the current study and statistical code will be available from the corresponding author upon reasonable request. The study protocol has been approved by the Institutional ethical committee of the Indian Spinal Injuries Centre and is registered with the Clinical Trials Registry India Randomization: Eligible individuals will be assigned randomly to either the Intervention or Control group. Randomization will be performed using computer-generated randomization sequence generated by the Random Allocation Software, using a 1:1 allocation ratio. To ensure concealment, the allocation sequence will be marked sequentially and sealed in opaque envelopes. An individual not associated with the study will sequentially open the numbered envelopes to reveal the participant’s group allocation. Based upon this, participants will be allocated to group A or group B. Blinding: The trial will be a double-blinded study where the outcome assessor who will be a physiotherapist and participants will be blinded to group allocation. The principal investigator will be informed of the group allocation given the nature of the interventions. Also, the statistician who will perform data analysis would be unaware of the existence of treatment groups. Intervention: VR based balance training will be provided by the Nintendo Wii Sports Resort (Nintendo Co. Ltd., Kyoto, Japan). It uses a central game console connected to a 127-cm (50-inch) screen wall-mounted television. Navigation is via the handheld remote control in the gaming environment. The choice of games was based on the similarity between the training and real-life conditions and based on previous research using the Nintendo Wii in training sitting balance in various neurological populations. During the first session, the therapist shall demonstrate the game controls and instructions to ensure that the participants understand how to control the system. Furthermore, the therapist shall offer verbal and manual guidance to all participants to help them learn the best strategies to reach the highest scores in each game. An equal number of rounds for each exercise shall be presented to the participants during each training session. Rest would be allowed and training would be resumed afterward if the subject declares fatigue. Participants in the VR-SES group shall receive SES while performing virtual reality-based balance training. SES shall be delivered using a TENS machine (HMS DigitensII) that uses surface self-adhesive stimulation electrodes placed on the subject’s skin corresponding to the muscles targeted. The key muscles that shall be targeted are the Erector Spinae. The pulse width will be 200 µs and the pulse frequency will be 100 Hz. The current levels shall be separately selected such that the participant felt the stimulation at the level (Suprasensory threshold) without having the stimulated muscles contract due to the stimulation [ 25 ]. Adverse events will be monitored and reported if any. (Enter Table 3) Progression and feedback: The initial difficulty of the exercises shall be adjusted for each participant based on their performance during the familiarization session, the difficulty level of the game will be gradually increased. The participants will receive a concomitant visual and auditory knowledge of the results of the success of the task when movements are accurately made within a specified time because learning is also affected by performance-related feedback. On the other hand, participants will also receive negative knowledge of the performance of the use of compensatory strategies while performing games using the Nintendo Wii Sports Resort. Termination criteria: The intervention will be terminated if any kind of unusual uneasiness is reported by the participants. Protocol modification, if required will be done only after proposing the changes to the Research Review Committee and Institutional Ethical Committee and after approval, the same will be notified to CTRI and the Journal. Any deviations from the protocol will be fully documented using a breach report form. Adherence: The adherence of the participants recruited in the study will be monitored by documenting the details of sessions attended. Participants in all groups shall receive VR-based balance training exercises which may positively influence adherence and reduce attrition rates because all groups are likely to feel engaged in an active intervention. The participants will be permitted to increase the training duration by 1 week keeping in mind the “intention-to-treat” analysis principle if the participants are unable to complete the total number of sessions within the stipulated 4 weeks. Also, the type, extent and pattern of missing data throughout the study will be fully reported by the authors. Outcome variables: Modified Functional Reach Test (mFRT) - The participant sits in a standard wheelchair, hips, knees and ankles positioned at approximately 90° and feet supported. Initial reach is measured against a yardstick mounted on the wall and then the maximum forward reach is measured using ulnar styloid process as landmark. The difference between is the measure of functional reach in sitting position. Each participant performs three trials and the average of these measurements is used for analysis. It has been reported to have good to excellent reliability, with ICC values ranging from 0.78 to 0.99 [ 26 ]. Star test - ProKin trunk sensor platform (ProKin PK252; TechnoBody Inc., Dalmine, Italy) will be used. Participant sits on the Prokin 252 multi axial platform with back straight and hip & knee flexed at 90*. During the star test, a target appears in different directions on the screen. The patient has to reach the target on a given path by shifting his weight towards that direction. The shifting of weight is done by moving the multi axial platform in different directions. After a series of such movements, the Tecnobody software gives a final report in terms of total area covered during the test. I t has been found that the Prokin device is reliable and valid for assessing standing balance in individuals with incomplete SCI, Test- retest reliability was found to be moderate to excellent (ICC = 0.64–0.93) [ 27 ]. International SCI Quality of Life Data Set- Version 1.0 It was developed as a brief QoL measure for use in clinical practice and research. It consists of 3 items for an individual to rate their satisfaction with life, physical health and psychological health. Each domain is ranked on a 0–10 scale, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. The tool has been reported to be both valid and reliable. The three items exhibited strong inter-correlations, ranging from 0.48 to 0.71. Furthermore, the scale demonstrated good internal consistency with a Cronbach's alpha of 0.81, and item-rest correlations fell between 0.57 and 0.74 [ 28 ]. Statistics - Sample size: A priori sample size estimation was done using the G*Power 3 software ( 3.1.9.6 , Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany) by considering modified functional reach test as the primary outcome measure. The total sample size was calculated at 20 by using an α level of 0.05, a power of 80%. The potential loss to attrition was estimated at 10%. Hence the total sample size was 22. Statistical Analysis: To check for selection bias, we will apply Pearson’s chi-square test for categorical variables and Student t-test for numerical variables. This will be performed to know if the randomization process generated between each group of participants has homogenous clinical and demographic characteristics before the intervention. Continuous variables will be summarized as mean ± standard deviation for normal distribution and median ± interquartile range for non-normal distribution. The Shapiro-Wilk test will be used to know the normality of data. In the case of normal distribution of data, we will analyze the intergroup comparison by applying a two-sample t-test. In case of skewed data, we will use the Mann- Whitney U test for the intergroup comparison. The intragroup comparison will be analyzed by Repeated measure ANOVA or Friedman’s test (if data is not normally distributed). The final statistical analysis will be performed using IBM SPSS Ver. 29.0 (IBM Corp., Armonk, NY, USA). This will be done based on the modified intention-to-treat principle, whereby each participant must complete > 75% (18 of 24 sessions) of planned exercise sessions. The principle of the “last observation carried forward” shall be applied in case of missing data of dropped-out individuals. The level of statistical significance is assumed at p-value < 0.05. Discussion The recovery of sitting balance is one of the primary and essential aims of rehabilitative programs in individuals with iSCI. Retraining sitting balance is challenging for healthcare professionals dealing with iSCI. The trial will provide information about the effectiveness of SES augmented VR based balance training in improving sitting balance and QoL in persons with iSCI. It is believed that the results of this training will help to improve sitting balance and QOL in persons with iSCI. To the best of our knowledge, no study till now has examined the effectiveness of SES augmented VR based training on sitting balance and QoL in the human iSCI population. This trial is designed to meet the methodological demand for adequate randomization, allocation concealment, blinding of outcome assessors and statisticians. The trial will be reported according to the CONSORT guidelines. The limitation of this trial is that the therapist administering the treatment will not be blinded. The recruitment of the participants shall be done through a purposive sample from one rehabilitation center in New Delhi. Trial Status: The second version of the original protocol after amendments was finalized on 02nd March 2024. The first participant in the trial was recruited in August 2024 and the expected duration of the participant's recruitment to complete the study is approximately in April 2025. Abbreviations SCI Spinal Cord Injury iSCI Incomplete Spinal Cord Injury QoL Quality of Life VR Virtual Reality SES Sensory Electrical Stimulation mFRT Modified functional reach test ISCoS QoL BDS International Spinal Cord Society Quality of life Basic Data Set Declarations Ethics approval and consent to participate: The trial is approved by the Institutional Ethical Committee of Indian Spinal Injuries Centre REGD NO: ECR/96/Inst/DL/2013/RR-19 with reference number ISIC/RP/2024/002. Written, informed consent to participants will be obtained from all participants. Consent for publication: Not Applicable- no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are attached. Availability of data and materials: Any data required to support the protocol can be provided on request by keeping the participant's details confidential. Competing interests: No potential conflict of interest relevant to this study protocol is reported among the authors. Funding: There is no funding involved with this trial. This is an investigator-initiated RCT. Authors' contributions: All authors were involved in the conception and design of this study. The leading author prepared the protocol manuscript, all authors contributed to the review and approval of the final manuscript. Acknowledgments: Not applicable. Dissemination policy- Trial results : The results of the study will be shared through scientific research publications, databases, the trial register, data-sharing arrangements, social media and conferences. There are no publication restrictions. Also, a layman's summary of the results of this study can be provided to all the participants. References Furlan JC, Sakakibara BM, Miller WC, Krassioukov AV. Global incidence and prevalence of traumatic spinal cord injury. Can J Neurol Sci. 2013;40:456–64. 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Effects of sit-to-stand training combined with transcutaneous electrical stimulation on spasticity, muscle strength and balance ability in patients with stroke: a randomized controlled study. Gait Posture. 2017;54:183–7. Arsh A, Darain H, Ullah I, Shakil-ur-Rehman S. Diagnostic tests to assess balance in patients with spinal cord injury: a systematic review of their validity and reliability. Asian Biomed. 2021;15(3):111–8. Validity and Reliability of Prokin 252N (Tecnobody.) Balance System for Assessment of Standing Balance in Individuals with Incomplete Spinal Cord Injury, IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455–2631, Vol.8, Issue 1, page no.1084–1093, January-2023. Post MW, Adriaansen JJ, Charlifue S, Biering-Sørensen F, Van Asbeck FW. Good validity of the international spinal cord injury quality of life basic data set. Spinal Cord. 2016;54(4):314–8. Tables Tables 1 to 3 are available in the Supplementary Files section. Supplementary Files tablestrials.pdf Additionalfile.docx Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Minor revision 27 Apr, 2026 Reviewers agreed at journal 28 Jul, 2025 Reviewers invited by journal 11 Jun, 2025 Editor invited by journal 29 Apr, 2025 Editor assigned by journal 17 Mar, 2025 First submitted to journal 16 Mar, 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. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-6213083","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":469783518,"identity":"edaf613a-735a-46dd-9b36-e3773ff440d5","order_by":0,"name":"Nikhil Chowdhary","email":"data:image/png;base64,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","orcid":"https://orcid.org/0009-0007-0099-6476","institution":"Indian Spinal Injuries Centre","correspondingAuthor":true,"prefix":"","firstName":"Nikhil","middleName":"","lastName":"Chowdhary","suffix":""},{"id":469783519,"identity":"f3057526-2210-4db4-9b5b-35ac186292e4","order_by":1,"name":"Stuti Khanna","email":"","orcid":"","institution":"Indian Spinal Injuries Centre","correspondingAuthor":false,"prefix":"","firstName":"Stuti","middleName":"","lastName":"Khanna","suffix":""},{"id":469783520,"identity":"ffcb2bcf-11be-4b83-8644-ac9bff547584","order_by":2,"name":"Garima Wadhwa","email":"","orcid":"","institution":"Indian Spinal Injuries Centre","correspondingAuthor":false,"prefix":"","firstName":"Garima","middleName":"","lastName":"Wadhwa","suffix":""},{"id":469783521,"identity":"df294920-18b5-4d29-b192-cf55774525d9","order_by":3,"name":"Shefali Walia","email":"","orcid":"","institution":"Gurugram University","correspondingAuthor":false,"prefix":"","firstName":"Shefali","middleName":"","lastName":"Walia","suffix":""}],"badges":[],"createdAt":"2025-03-12 14:44:32","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6213083/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6213083/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":84816856,"identity":"2740f021-58c7-4af0-98c5-5695acde57d6","added_by":"auto","created_at":"2025-06-17 15:46:31","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":683605,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend.\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-6213083/v1/dcf60d89ac46bf20954b8fd1.jpeg"},{"id":84821278,"identity":"778c2393-5103-48e1-b6f7-5667bda11567","added_by":"auto","created_at":"2025-06-17 16:10:31","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1352284,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6213083/v1/de863bb8-13f6-48c5-86e3-b095d1d063c8.pdf"},{"id":84816855,"identity":"c6c0b0a2-ad29-4647-8836-a066b760facd","added_by":"auto","created_at":"2025-06-17 15:46:30","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":142933,"visible":true,"origin":"","legend":"","description":"","filename":"tablestrials.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6213083/v1/9e3658fafaeb41bdd846f58c.pdf"},{"id":84819859,"identity":"1b6d9c19-83f1-449b-b044-ad20eed6859a","added_by":"auto","created_at":"2025-06-17 16:02:31","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":40776,"visible":true,"origin":"","legend":"","description":"","filename":"Additionalfile.docx","url":"https://assets-eu.researchsquare.com/files/rs-6213083/v1/734370b9229426cbfe6b14ed.docx"}],"financialInterests":"","formattedTitle":"Effectiveness of Sensory Electrical Stimulation Augmented Virtual Reality Training on Sitting Balance and Quality of Life in individuals with Incomplete Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial","fulltext":[{"header":"Background","content":"\u003cp\u003eSpinal cord injury (SCI) is a debilitating neurological condition which is characterized by sensory, motor, autonomic or bowel dysfunction caused by damage to neuronal elements of the spinal cord. It's incidence ranges from 8 to 246 cases per million worldwide whereas the prevalence ranges from 236 to 1298 per million [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003ewith approximately 20,000 new cases documented annually in India\u003c/span\u003e [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eNotably, countries like India are at high risk with an average age group ranging from 26.8 to 56.6 years with a male-to-female ratio of 4:1\u003c/span\u003e [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. It often leads to profound disability that negatively impacts physiological, physical or psychological well-being and restricts employment opportunities even after the individual has reintegrated into community.\u003c/p\u003e \u003cp\u003eFollowing SCI, maintaining sitting balance is essential for performing activities of daily living (ADLs). Approximately 70\u0026ndash;80% of individuals with SCI experience impaired or no trunk control, which adversely affects their ability to maintain sitting balance and overall QoL [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Trunk instability is a significant concern for individuals with SCI [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e], as it impacts their ability to perform everyday tasks such as bed movements, unsupported sitting and self-care activities [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e][\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Additionally, it can also lead to secondary complications such as pressure sores [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e], spinal deformities [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] and pulmonary dysfunction [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Furthermore, individuals with SCI are also at a higher risk of falls even during stationary sitting, leading to fall-related pain, bone fractures [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Consequently, QoL in individuals with SCI is closely linked to their dynamic sitting balance and ability to sit unsupported [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] a relationship that becomes increasingly important over time post-injury [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eGiven these challenges, recovery of trunk control is essential for those experiencing difficulties with sitting balance [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. However, research investigating sitting balance in individuals with iSCI remains limited [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Conventional methods for maintaining sitting stability often involve belts, straps and customized seating adaptations designed to stabilize the trunk and prevent falls while facilitating upper limb function [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Unfortunately, these techniques can restrict dynamic mobility and hinder the ability to reach for objects [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe recovery of sitting balance is a primary objective in rehabilitation programs for individuals with iSCI. While research on effective balance training protocols for individuals with iSCI is scarce, recent advancements and \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eexistence of many strategies like Electrical stimulation\u003c/span\u003e [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e], \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eNon-Invasive Spinal Stimulation\u003c/span\u003e [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e], \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eCommunity exercise Programme\u003c/span\u003e [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e], \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eFunctional Electrical Stimulation\u003c/span\u003e [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e] \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eand VR\u003c/span\u003e [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003edemonstrates improvement in mobility along with postural control.\u003c/span\u003e Methods utilizing VR have demonstrated positive results for training balance across various neurological populations. VR offers the advantage of creating multiple sensory inputs visual, sensory, and auditory feedback through task-specific approaches in a virtual environment that mimics real-world scenarios. This technology provides a user-computer interface that facilitates real-time simulation of activities or environments, allowing user interaction through various sensory modalities and enhancing engagement and motivation during rehabilitation. Previous studies utilizing game-based exercises within VR have shown improvements in dynamic sitting balance among individuals with SCI [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSES involves use of low-intensity currents (below, at or only just above the sensory threshold), which do not induce any visible muscle contraction and provides only sensory information. The beneficial effects of SES are thought to occur at the peripheral (sensory receptors sensitivity), spinal (spinal motoneural excitability) and supra-spinal (cortex reorganisation or adaptation) levels. SES appears to be particularly useful to reinforce or restore the postural function in the immediate/ concurrent, acute or chronic application in pathological populations. Studies have already shown that SES is effective at improving postural balance in various neurological conditions such as stroke, cerebral palsy [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eTherefore, this study aims to investigate the effectiveness of SES augmented VR training on sitting balance and QoL in individuals with incomplete SCI. It is hypothesized that significant improvement in sitting balance and QoL will be noticeable after 4 weeks of SES augmented VR training when compared with participants receiving VR training alone.\u003c/p\u003e"},{"header":"Materials and methods","content":"\u003cp\u003eA clinical trial is designed to evaluate the effectiveness of the SES augmented VR based balance Training on sitting balance and QoL in individuals with iSCI.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003ePatient and study design:\u003c/h2\u003e \u003cp\u003eA double-blind, parallel, two-group, randomized controlled trial with equal subject allocation (1:1) will be undertaken. A purposive sample of 22 participants with iSCI will be recruited from the inpatient and outpatient rehabilitation departments of the Indian Spinal Injuries Centre, New Delhi, India. All participants will be provided with information sheets and written consent will be obtained by the principal investigator before recruitment. The demographic details will be obtained and the participants will be selected based on the eligibility criteria after neurological examination (Table\u0026nbsp;1).\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003e(Enter Table 1)\u003c/h3\u003e\n\u003cp\u003eThe participants will be randomly assigned to any of the two groups: virtual reality-based balance training\u0026thinsp;+\u0026thinsp;sensory electrical stimulation (VR-SES) group and virtual reality-based balance training (VR) group for five times a week for four weeks.\u003c/p\u003e \u003cp\u003eDRRC and RRC of the research department of the Indian Spinal Injuries Centre hold the legal liability and keep the check and record of all potential recruits and monitor the data collection throughout the intervention. The members of DRRC along with the consultants and physiotherapists in the hospital provide day-to-day support to all aspects of the local organization of the trial. The trial is supervised by the guides and co-guides twice a week. This research protocol is consistent with the current Consolidated Standards of Reporting Trials (CONSORT) guidelines (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) and follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT schedule) (Table\u0026nbsp;2) [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] and is developed based on the SPIRIT checklist (Additional document). A visual description of the study regarding enrollment, assessments and interventions is shown in Table\u0026nbsp;2.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eBaseline assessments (T\u003csub\u003e0\u003c/sub\u003e) will be done before group allocation. Post-intervention assessments of both the groups (T\u003csub\u003e1\u003c/sub\u003e) will be done after 4 weeks of intervention to detect potential long-term effects.\u003c/p\u003e\n\u003ch3\u003e(Enter Table 2)\u003c/h3\u003e\n\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003e(Enter Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003c/h2\u003e \u003cdiv id=\"Sec7\" class=\"Section3\"\u003e \u003ch2\u003eEthical considerations:\u003c/h2\u003e \u003cp\u003eThe enrolled participants will be informed orally and in writing about the purpose of this trial, its potential risks, benefits of participation and the right to withdraw from the trial at any point during the study. A written informed consent signed by the participants will be taken from those who are willing to participate in the study.\u003c/p\u003e \u003cp\u003eThe data of the participants will be collected, documented, and managed confidentially using the paper-based entry data sets. Only all the authors related to the trial will have access to the final trial dataset. The masked datasets analyzed during the current study and statistical code will be available from the corresponding author upon reasonable request. The study protocol has been approved by the Institutional ethical committee of the Indian Spinal Injuries Centre and is registered with the Clinical Trials Registry India\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eRandomization:\u003c/h2\u003e \u003cp\u003eEligible individuals will be assigned randomly to either the Intervention or Control group. Randomization will be performed using computer-generated randomization sequence generated by the Random Allocation Software, using a 1:1 allocation ratio.\u003c/p\u003e \u003cp\u003eTo ensure concealment, the allocation sequence will be marked sequentially and sealed in opaque envelopes. An individual not associated with the study will sequentially open the numbered envelopes to reveal the participant\u0026rsquo;s group allocation. Based upon this, participants will be allocated to group A or group B.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eBlinding:\u003c/h3\u003e\n\u003cp\u003eThe trial will be a double-blinded study where the outcome assessor who will be a physiotherapist and participants will be blinded to group allocation. The principal investigator will be informed of the group allocation given the nature of the interventions. Also, the statistician who will perform data analysis would be unaware of the existence of treatment groups.\u003c/p\u003e\n\u003ch3\u003eIntervention:\u003c/h3\u003e\n\u003cp\u003eVR based balance training will be provided by the Nintendo Wii Sports Resort (Nintendo Co. Ltd., Kyoto, Japan). It uses a central game console connected to a 127-cm (50-inch) screen wall-mounted television. Navigation is via the handheld remote control in the gaming environment. The choice of games was based on the similarity between the training and real-life conditions and based on previous research using the Nintendo Wii in training sitting balance in various neurological populations. During the first session, the therapist shall demonstrate the game controls and instructions to ensure that the participants understand how to control the system. Furthermore, the therapist shall offer verbal and manual guidance to all participants to help them learn the best strategies to reach the highest scores in each game. An equal number of rounds for each exercise shall be presented to the participants during each training session. Rest would be allowed and training would be resumed afterward if the subject declares fatigue.\u003c/p\u003e \u003cp\u003eParticipants in the VR-SES group shall receive SES while performing virtual reality-based balance training. SES shall be delivered using a TENS machine (HMS DigitensII) that uses surface self-adhesive stimulation electrodes placed on the subject\u0026rsquo;s skin corresponding to the muscles targeted. The key muscles that shall be targeted are the Erector Spinae. The pulse width will be 200 \u0026micro;s and the pulse frequency will be 100 Hz. The current levels shall be separately selected such that the participant felt the stimulation at the level (Suprasensory threshold) without having the stimulated muscles contract due to the stimulation [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eAdverse events will be monitored and reported if any.\u003c/span\u003e\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003e(Enter Table\u0026nbsp;3)\u003c/h2\u003e \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e \u003ch2\u003eProgression and feedback:\u003c/h2\u003e \u003cp\u003eThe initial difficulty of the exercises shall be adjusted for each participant based on their performance during the familiarization session, the difficulty level of the game will be gradually increased. The participants will receive a concomitant visual and auditory knowledge of the results of the success of the task when movements are accurately made within a specified time because learning is also affected by performance-related feedback. On the other hand, participants will also receive negative knowledge of the performance of the use of compensatory strategies while performing games using the Nintendo Wii Sports Resort.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eTermination criteria:\u003c/h2\u003e \u003cp\u003eThe intervention will be terminated if any kind of unusual uneasiness is reported by the participants. Protocol modification, if required will be done only after proposing the changes to the Research Review Committee and Institutional Ethical Committee and after approval, the same will be notified to CTRI and the Journal. \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eAny deviations from the protocol will be fully documented using a breach report form.\u003c/span\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eAdherence:\u003c/h2\u003e \u003cp\u003eThe adherence of the participants recruited in the study will be monitored by documenting the details of sessions attended. Participants in all groups shall receive VR-based balance training exercises which may positively influence adherence and reduce attrition rates because all groups are likely to feel engaged in an active intervention.\u003c/p\u003e \u003cp\u003eThe participants will be permitted to increase the training duration by 1 week keeping in mind the \u0026ldquo;intention-to-treat\u0026rdquo; analysis principle if the participants are unable to complete the total number of sessions within the stipulated 4 weeks. Also, the type, extent and pattern of missing data throughout the study will be fully reported by the authors.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eOutcome variables:\u003c/h2\u003e \u003cp\u003e \u003cem\u003eModified Functional Reach Test (mFRT)\u003c/em\u003e - The participant sits in a standard wheelchair, \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003ehips, knees and ankles positioned at approximately 90\u0026deg; and feet supported.\u003c/span\u003e Initial reach is measured against a yardstick mounted on the wall and then the maximum forward reach is measured using ulnar styloid process as landmark. The difference between is the measure of functional reach in sitting position. Each participant performs three trials and the average of these measurements is used for analysis. It has been \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003ereported to have good to excellent reliability, with ICC values ranging from 0.78 to 0.99\u003c/span\u003e [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e \u003cp\u003e \u003cem\u003eStar test -\u003c/em\u003e ProKin trunk sensor platform (ProKin PK252; TechnoBody Inc., Dalmine, Italy) will be used. Participant sits on the Prokin 252 multi axial platform with back straight and hip \u0026amp; knee flexed at 90*. During the star test, a target appears in different directions on the screen. The patient has to reach the target on a given path by shifting his weight towards that direction. The shifting of weight is done by moving the multi axial platform in different directions. After a series of such movements, the Tecnobody software gives a final report in terms of total area covered during the test. I\u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003et has been found that the Prokin device is reliable and valid for assessing standing balance in individuals with incomplete SCI, Test- retest reliability was found to be moderate to excellent (ICC\u0026thinsp;=\u0026thinsp;0.64\u0026ndash;0.93)\u003c/span\u003e [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e].\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eInternational SCI Quality of Life Data Set- Version 1.0\u003c/strong\u003e \u003cp\u003eIt was developed as a brief QoL measure for use in clinical practice and research. It consists of 3 items for an individual to rate their satisfaction with life, physical health and psychological health. Each domain is ranked on a 0\u0026ndash;10 scale, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eThe tool has been reported to be both valid and reliable. The three items exhibited strong inter-correlations, ranging from 0.48 to 0.71. Furthermore, the scale demonstrated good internal consistency with a Cronbach's alpha of 0.81, and item-rest correlations fell between 0.57 and 0.74\u003c/span\u003e [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e].\u003c/p\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eStatistics -\u003c/h2\u003e \u003cdiv id=\"Sec17\" class=\"Section3\"\u003e \u003ch2\u003eSample size:\u003c/h2\u003e \u003cp\u003eA priori sample size estimation was done using the G*Power 3 software (\u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003e3.1.9.6\u003c/span\u003e, Heinrich-Heine-Universit\u0026auml;t D\u0026uuml;sseldorf, D\u0026uuml;sseldorf, Germany) by considering modified functional reach test as the primary outcome measure. The total sample size was calculated at 20 by using an α level of 0.05, a power of 80%. The potential loss to attrition was estimated at 10%. Hence the total sample size was 22.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis:\u003c/h2\u003e \u003cp\u003eTo check for selection bias, we will apply Pearson\u0026rsquo;s chi-square test for categorical variables and Student t-test for numerical variables. This will be performed to know if the randomization process generated between each group of participants has homogenous clinical and demographic characteristics before the intervention.\u003c/p\u003e \u003cp\u003eContinuous variables will be summarized as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation for normal distribution and median\u0026thinsp;\u0026plusmn;\u0026thinsp;interquartile range for non-normal distribution. The Shapiro-Wilk test will be used to know the normality of data. In the case of normal distribution of data, we will analyze the intergroup comparison by applying a two-sample t-test. In case of skewed data, we will use the Mann- Whitney U test for the intergroup comparison. The intragroup comparison will be analyzed by Repeated measure ANOVA or Friedman\u0026rsquo;s test (if data is not normally distributed). The final statistical analysis will be performed using IBM SPSS Ver. 29.0 (IBM Corp., Armonk, NY, USA). \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eThis will be done based on the modified intention-to-treat principle, whereby each participant must complete\u0026thinsp;\u0026gt;\u0026thinsp;75% (18 of 24 sessions) of planned exercise sessions. The principle of the \u0026ldquo;last observation carried forward\u0026rdquo; shall be applied in case of missing data of dropped-out individuals.\u003c/span\u003e The level of statistical significance is assumed at p-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe recovery of sitting balance is one of the primary and essential aims of rehabilitative programs in individuals with iSCI. Retraining sitting balance is challenging for healthcare professionals dealing with iSCI. The trial will provide information about the effectiveness of SES augmented VR based balance training in improving sitting balance and QoL in persons with iSCI. It is believed that the results of this training will help to improve sitting balance and QOL in persons with iSCI. To the best of our knowledge, no study till now has examined the effectiveness of SES augmented VR based training on sitting balance and QoL in the human iSCI population.\u003c/p\u003e \u003cp\u003eThis trial is designed to meet the methodological demand for adequate randomization, allocation concealment, blinding of outcome assessors and statisticians. The trial will be reported according to the CONSORT guidelines. \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eThe limitation of this trial is that the therapist administering the treatment will not be blinded. The recruitment of the participants shall be done through a purposive sample from one rehabilitation center in New Delhi.\u003c/span\u003e\u003c/p\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eTrial Status:\u003c/h2\u003e \u003cp\u003e \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eThe second version of the original protocol after amendments was finalized on 02nd March 2024.\u003c/span\u003e The first participant in the trial was recruited in August 2024 and the expected duration of the participant's recruitment to complete the study is approximately in April 2025.\u003c/p\u003e \u003c/div\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSCI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSpinal Cord Injury\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eiSCI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eIncomplete Spinal Cord Injury\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eQoL\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eQuality of Life\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eVR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eVirtual Reality\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSES\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSensory Electrical Stimulation\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003emFRT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eModified functional reach test\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eISCoS QoL BDS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eInternational Spinal Cord Society Quality of life Basic Data Set\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthics approval and consent to participate:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eThe trial is approved by the Institutional Ethical Committee of Indian Spinal Injuries Centre REGD NO: ECR/96/Inst/DL/2013/RR-19 with reference number ISIC/RP/2024/002. Written, informed consent to participants will be obtained from all participants.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConsent for publication:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eNot Applicable-\u0026nbsp;no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the\u0026nbsp;trial\u0026nbsp;results. The participant information materials and informed consent form are attached.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAvailability of data and materials:\u003c/em\u003e\u003c/strong\u003e Any data required to support the protocol can be provided on request by keeping the participant\u0026apos;s details confidential.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCompeting interests:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eNo potential conflict of interest relevant to this study protocol is reported among the authors.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eThere is no funding involved with this trial. This is an investigator-initiated RCT.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthors\u0026apos; contributions:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eAll authors were involved in the conception and design of this study. The leading author prepared the protocol manuscript, all authors contributed to the review and approval of the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAcknowledgments:\u003c/em\u003e\u003c/strong\u003e Not applicable.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDissemination policy- Trial results\u003c/em\u003e\u003c/strong\u003e: The results of the study will be shared through scientific research publications, databases, the trial register, data-sharing arrangements, social media and conferences. There are no publication restrictions. Also, a layman\u0026apos;s summary of the results of this study can be provided to all the participants.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eFurlan JC, Sakakibara BM, Miller WC, Krassioukov AV. Global incidence and prevalence of traumatic spinal cord injury. 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Biomedicines. 2022b;11(1):34. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.3390/biomedicines11010034\u003c/span\u003e\u003cspan address=\"10.3390/biomedicines11010034\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTriolo RJ, Bailey SN, Lombardo LM, Miller ME, Foglyano K, Audu ML. Effects of intramuscular trunk stimulation on manual wheelchair propulsion mechanics in 6 subjects with spinal cord injury. Arch Phys Med Rehabil. 2013a;94(10):1997\u0026ndash;2005.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFriederich AR, Bao X, Triolo RJ, Audu ML. Feedback control of upright seating with functional neuromuscular stimulation during a functional task after spinal cord injury: a case study. 2021 43rd Annual International Conference of the IEEE Engineering in Medicine \u0026amp; Biology Society (EMBC): IEEE. 2021;5719\u0026ndash;22. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1109/EMBC46164.2021.9629582\u003c/span\u003e\u003cspan address=\"10.1109/EMBC46164.2021.9629582\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eArmstrong KL, Lombardo LM, Foglyano KM, Audu ML, Triolo RJ. Automatic application of neural stimulation during wheelchair propulsion after SCI enhances recovery of upright sitting from destabilizing events. 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J Neuroeng Rehabil. 2015b;12:1\u0026ndash;9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/s12984-015-0091-8\u003c/span\u003e\u003cspan address=\"10.1186/s12984-015-0091-8\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAbou L, Malala VD, Yarnot R, Alluri A, Rice LA. Effects of virtual reality therapy on gait and balance among individuals with spinal cord injury: A systematic review and meta-analysis. Neurorehabilit Neural Repair. 2020;34(5):375\u0026ndash;88.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMiguel-Rubio AD, Rubio MD, Salazar A, Moral-Munoz JA, Requena F, Camacho R, Lucena-Anton D. Is virtual reality effective for balance recovery in patients with spinal cord injury? A systematic review and meta-analysis. J Clin Med. 2020;9(9):2861.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKhurana M, Walia S, Noohu MM. Study on the effectiveness of virtual reality game-based training on balance and functional performance in individuals with paraplegia. Top spinal cord injury rehabilitation. 2017;23(3):263\u0026ndash;70.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGoel T, Sharma N, Gehlot A, Srivastav AK. Effectiveness of immersive virtual reality training to improve sitting balance control among individuals with acute and sub-acute paraplegia: A randomized clinical trial. J Spinal Cord Med. 2023;46(6):964\u0026ndash;74.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTak S, Choi W, Lee S. Game-based virtual reality training improves sitting balance after spinal cord injury: a single-blinded, randomized controlled trial. Med Sci Technol. 2015;56:53\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchr\u0026ouml;der J, Truijen S, Van Criekinge T, Saeys W. Peripheral somatosensory stimulation and postural recovery after stroke\u0026ndash;a systematic review. Top Stroke Rehabil. 2018;25(4):312\u0026ndash;20.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePaillard T. Sensory electrical stimulation and postural balance: a comprehensive review. Eur J Appl Physiol. 2021;121:3261\u0026ndash;81.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChan AW, Tetzlaff JM, G\u0026oslash;tzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hr\u0026oacute;bjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJung KS, In TS, Cho HY. Effects of sit-to-stand training combined with transcutaneous electrical stimulation on spasticity, muscle strength and balance ability in patients with stroke: a randomized controlled study. Gait Posture. 2017;54:183\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eArsh A, Darain H, Ullah I, Shakil-ur-Rehman S. Diagnostic tests to assess balance in patients with spinal cord injury: a systematic review of their validity and reliability. Asian Biomed. 2021;15(3):111\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eValidity and Reliability of Prokin 252N (Tecnobody.) Balance System for Assessment of Standing Balance in Individuals with Incomplete Spinal Cord Injury, IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455\u0026ndash;2631, Vol.8, Issue 1, page no.1084\u0026ndash;1093, January-2023.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePost MW, Adriaansen JJ, Charlifue S, Biering-S\u0026oslash;rensen F, Van Asbeck FW. Good validity of the international spinal cord injury quality of life basic data set. Spinal Cord. 2016;54(4):314\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 3 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Spinal cord injury, Sitting balance, Quality of life, Virtual reality, Sensory electrical stimulation, Rehabilitation","lastPublishedDoi":"10.21203/rs.3.rs-6213083/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6213083/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Individuals with incomplete Spinal Cord Injury (iSCI) often face significant impairments in sitting balance and mobility due to trunk instability. These challenges can severely impact functional abilities, participation in daily activities and overall Quality of Life (QoL). Studies have highlighted the potential of virtual reality (VR) training to improve sitting balance in individuals with iSCI. Furthermore, Sensory Electrical Stimulation (SES) has shown positive effects on sitting balance in various neurological populations. However, research exploring the combined effectiveness of VR and SES on sitting balance and QoL specifically within the iSCI human population remains limited. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethodology\u003c/strong\u003e: This study will be a double-blind parallel, two-group, randomized controlled trial that aims to evaluate the effectiveness of SES augmented VR training on sitting balance and QoL in individuals with iSCI. A total of 22 participants with iSCI, with a neurological level of injury between T6 and T12 will be recruited from the rehabilitation department at the Indian Spinal Injuries Centre, adhering to inclusion criteria. Participants will be randomly assigned to one of two groups using a 1:1 allocation ratio. The intervention group will engage in VR-based balance training along with SES application, while the control group will solely engage in VR-based balance training. Both groups will undergo interventions consisting of 30-minute sessions, five times a week for a duration of 4 weeks.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcome measures\u003c/strong\u003e: The assessment of sitting balance will be done using the Modified Functional Reach Test (mFRT) and the Star Test using the Tecnobody Prokin 252 Trunk Sensor.\u0026nbsp; Additionally, the International Spinal Cord Society Quality of Life Basic Data Set (ISCoS QoL BDS) Version 1.0 will be used to measure QoL.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e: The effectiveness of the SES augmented VR based balance training program will be evaluated based on the changes in the mFRT, Star Test (Prokin 252 Trunk Sensor) and ISCoS Quality of Life Basic Data Set Version 1.0 following four weeks of intervention. This trial aims to enhance understanding of how SES augmented VR training can improve sitting balance and QoL in individuals with iSCI.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial Registration\u003c/strong\u003e: The trial is registered with the Clinical Trials Registry – India on 18\u003csup\u003eth\u003c/sup\u003e April 2024 with registration number CTRI/2024/04/065897.\u003c/p\u003e","manuscriptTitle":"Effectiveness of Sensory Electrical Stimulation Augmented Virtual Reality Training on Sitting Balance and Quality of Life in individuals with Incomplete Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-06-17 15:46:26","doi":"10.21203/rs.3.rs-6213083/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Minor revision","date":"2026-04-27T08:36:46+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2025-07-28T10:24:17+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-06-11T11:38:30+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"Trials","date":"2025-04-29T11:23:16+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-17T10:20:23+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-03-16T16:12:15+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"32b25f3f-c9fa-4ca2-a0f3-fb5543aef18f","owner":[],"postedDate":"June 17th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-07T18:35:25+00:00","versionOfRecord":[],"versionCreatedAt":"2025-06-17 15:46:26","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6213083","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6213083","identity":"rs-6213083","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}