Effects of a nurse-led motor function rehabilitation training program for patients with ischemic stroke, and family caregivers: study protocol for a randomised controlled trial

Effects of a nurse-led motor function rehabilitation training program for patients with ischemic stroke, and family caregivers: study protocol for a randomised 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 Effects of a nurse-led motor function rehabilitation training program for patients with ischemic stroke, and family caregivers: study protocol for a randomised controlled trial Yue Ding, Juan Xu, Qian-Yu Liang, Jia-Qi Zheng, Feng Wang, Ying Lin, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3980686/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 14 Aug, 2024 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background: Both individuals and society bear a considerable burden from ischemic stroke (IS), not only do patients continue suffering from motor dysfunction after discharge from hospital, but their caregivers also undertake the principal responsibility of assisting them in reintegrating into the family and society. To better improve the IS patients’ limb function and daily life activities, their caregivers should also be involved in the training of the motor function rehabilitation during the period transitioning from hospital back home. This study mainly aims to investigate the effects of a nurse-led training for IS patients and their family caregivers on the improvement of the patients’ physical function and the burden of caregivers. Methods/design: A randomised controlled trial with blind assessment will be conducted in hospitals and during the follow-ups at home. Fifty-eight pairs of adults diagnosed with ischemic stroke and their primary caregivers will be included. Participants will be randomly given with (1) a nurse-led, home-based motor rehabilitation training participated by caregivers (intervention group) or (2) routine self-care (control group). Both groups will receive assessment and health guidance on the day of discharge, and the intervention group will receive an additional home-based training program and supervision. These two groups will be followed up every week after discharge. The primary results are drawn from the evaluation of physical function and caregiver-related burden, and the secondary results derived from statistics of the Modified Barthel Index, Stroke-specific Quality of Life and National Institutes of Health Stroke Scale. Differences between the two groups will be measured by two-way repeated measures ANOVA, considering the data at baseline and at 1-week and 4-week follow-up after training. Discussion: Results may provide novel and valuable information on the effects of this culturally appropriate, caregiver-involved, and home-based rehabilitation training on the physical function of IS patients and caregiver-related burden. Trial registration: Chinese Clinical Trial Registry (chictr.org.cn) ChiCTR2300078798. Registered on 19 December 2023. Ischemic Stroke Rehabilitation Home Nursing Caregiver Physical function Caregiver Burden Figures Figure 1 Figure 2 Introduction Background and rationale Ischemic stroke (IS) refers to the ischemic and hypoxic necrosis of local brain tissues, which is an irreversible damage caused by disorder of cerebral blood supply resulting from various factors [1]. According to statistics from the Global Burden of Diseases Study (GBD) [2], over the period from 1990 to 2019, the number of stroke and stroke-related deaths has presented a year-on-year escalation, reaching 12.2 million cases on a global scale in 2019. Among 143 million cases of stroke, there are 101 million cases of stroke-related disability and 6.55 million stroke-related deaths. Accounting for 11.6% of total deaths worldwide, stroke has been the second leading cause, among which 62.5% are attributed to ischemic stroke. Since 2015, stroke has been the major cause of death and disability in China, and an estimated 17.8 million adults in China had experienced a stroke in 2020[3]. Hemiplegia is a key sequela after the acute phase of IS [4] manifested by limb motor dysfunction [5], which has diminished the patients’ daily self-care capability and affected their health both physically and mentally [6]. Throughout the lengthy period of recovery from hemiplegia, the first 3 months after the onset of IS are recognized as the most optimal time for rehabilitation exercise [7]. In China, most IS survivors returned home after receiving treatment for the acute phase in hospitals [8, 9], while only a small number of IS patients continued motor function rehabilitation at clinics or community hospitals after discharge. Most IS patients chose to rely on themselves managing their post-stroke life at home , because of the considerable cost of long-term rehabilitation and the underdevelopment of primary healthcare system [10]. Currently, a well-prepared rehabilitation program providing direct guidance for both IS patients and caregivers has not yet been established, which hinder the patients’ self-assessment, intervention and management of physical function at home after discharge. Therefore, a scientific, individualised and affordable rehabilitation exercise program is essential to promote the recovery of the IS patients, who have limited availability to receive high-quality rehabilitation training and therapeutic support. After discharge, IS patients are faced with multifaceted challenges during the process of adapting to substantial changes in post-stroke life, such as re-entering the community and playing new social role [11]. Besides IS patients, their family caregivers are also confronted with considerable challenges [12, 13]. Caregivers need to learn a proper way to take care of stroke survivors at home, making good use of information and resources to not only improve their nursing efficacy, but also strike a balance between their work, personal life and caregiving duty. If these problems remain unresolved, the IS patients’ life quality may continue declining, the risk of accidental rehospitalization may elevate, and the burden and distress of caregivers may increase. Patients have strong rehabilitation needs, and their main caregivers also have obligations to help them with rehabilitation exercises [14]. Previous researches have investigated [15, 16] the home-based rehabilitation for IS patients, however, the main implementer is healthcare provider; So far, the caregiver-implemented rehabilitation for IS patients at home has seldom mentioned. Impacted by the ethos of Confucianism in China, family members of the discharged IS patients are usually considered as the main caregivers, namely their spouses, offspring, siblings, and other immediate relatives, however, the knowledge and skill trainings of rehabilitation they received are limited. Researches have acknowledged the effectiveness of direct rehabilitation trainings provided by professionals, to better implement rehabilitation, professionals should pay more attention to the patient empowerment[17, 18]. Patient empowerment, which is defined as the process by which people gain confidence and power in decisions and actions that affect their health, requires patients to participate, to have knowledge, self-efficacy, and health literacy. That is, health care workers should focus on improving patients’ independence, mobilising their self-confidence, empowering them to make decisions and teaching them self-assessment, rehabilitation training method selection and self-management throughout the rehabilitation process. Caregivers should also allow patients to participate as actively as possible in rehabilitation training. The crucial time for IS patients and their caregivers to master the skills in managing rehabilitation and nursing care is the post-discharge period transitioning to home from hospital [14], during which healthcare providers should offer knowledge, skill, information and emotional support to these patients and their caregivers, to ensure the continuity of rehabilitation. So far, evidence-based programs and procedures that are culturally integrated with Chinese feature have not been established, resulting in the lack of a reference for nurses to empower the discharged IS patients and their caregivers and to provide them with education related to physical function rehabilitation. Our study aims to explore whether our nurse-led, caregiver-involved, home-based rehabilitation education programme can improve the motor function outcomes of IS patient. This work also seeks to answer the following questions: Can this program improve patients' ability to perform daily activities? Can it enhance patients' quality of life? Can it alleviate the caregiver-related burden? The program comprises five steps, providing a reference for healthcare providers to leverage the initiative of caregivers and encourage patients to participate in limb function rehabilitation. This program aims to (1) help patients identify their problems; (2) identify effect factors of patients’ rehabilitation behaviour; (3) assist patients in setting long-term goals; (4) involve patients in the development of a home-based rehabilitation program; and (5) evaluate the effects. This nurse-led, caregiver-participated and interventional study will be conducted in collaboration with experts from multidisciplines to cover all areas of the topic. Objectives This work aims to conduct a randomised controlled study of a rehabilitation education programme, which is nursing team-led, caregiver-involved, healthcare provider-patient-caregiver shared, decision-made by using the Motor Assessment Scale (MAS), the Brunnstrom Assessment (BRS) and the NIHSS to determine whether it is superior to conventional rehabilitation in terms of the recovery of motor function of homebound IS patients. Methods Trial design This study is a two-arm single-blinded randomised controlled trial of an individual limb function rehabilitation intervention (Table 1) mediated by caregivers for IS survivors at home. The study will be named as nurse-led home-based limb function rehabilitation participated by caregivers (NHLRC). This randomised controlled trial has been registered in China Clinical Trial Registration Centre (registration number: ChiCTR2300078798) and approved by the Institutional Review Board of the First Affiliated Hospital of Shantou University (B-2023-213). The conduct of this study will follow the Declaration of Helsinki principles and has been designed in accordance with the SPIRIT 2013 statement [19]. After the baseline assessment of the patients, the patients will be randomly assigned to the NHLRC group and the control group by using a random number table. Study setting Participants will be recruited from multiple neurology departments and rehabilitation medicine wards of hospitals to achieve the target sample size. The study will be carried out in inpatient wards for face-to-face intervention and in patients’ family and community environment for online intervention in Shantou, Guangdong Province, China. Eligibility criteria The inclusion criteria for patients are as follows: (1) diagnosis of ischemic cerebral apoplexy according to the international classification of diseases (ICD) definition and in conformance to the guidelines of diagnosis and treatment of acute IS in China 2018 and confirmed by craniocerebral CT or MRI; (2) NIHSS score of 15 points or less on the day of discharge; (3) stable vital signs and clear consciousness; and (4) willingness of patients and their families to cooperate. The exclusion criteria for patients include the following: 1) unstable vital signs or unclear consciousness; 2) inability to express language correctly due to aphasia or dysarthria; 3) NIHSS score of more than 15 on the day of discharge; and 4) presence of other serious chronic or malignant diseases. The inclusion criteria for caregivers are as follows: 1) adult (18 years old or older); 2) physically healthy and normal cognitive ability, living ability, language communication ability and learning ability; and 3) primary caregiver. The exclusion criteria for caregivers are as follows: 1) presence of tumour and history of major surgery and severe trauma; and 2) with mental illness. Recruitment Basing on our defined sample size, we will recruit 58 patients from the neurology inpatient ward for a period of 3–5 months. Firstly, assessors will screen newly admitted patients with a diagnosis of IS daily through the electronic medical record system to initially identify patients for enrolment based on the inclusion and exclusion criteria. An independent research coordinator will review the information of patient and determine whether the patient meets the inclusion criteria, communicate with the patient to confirm and have the patient sign an informed consent form. Weekly meetings among study members will be organised to report on recruitment and discuss the progress to make adjustments accordingly. Recruitment time may be shortened or lengthened as appropriate depending on the recruitment situation. Recruitment will be stopped when the desired target has been reached. Participant withdrawal Participants may withdraw from the trial for any reason at any time. The researcher can withdraw participants from the study for safety purposes. Randomisation We will allocate eligible participants to the intervention or control group in a 1:1 ratio through simple randomisation with IBM SPSS Statistics version 25. Random numbers will be generated by a research assistant who is not involved in recruitment, intervention allocation or outcome assessment. After collecting baseline data for each group, the research assistant will place the subgroup data in sequentially numbered, opaque sealed envelopes to inform the intervention nurse. Evaluator blinding A researcher who is unaware of the intervention allocation will conduct outcome assessment and data entry and analysis. However, this study is not blinded due to the nature of the intervention; that is, the interventionist and carers of patients in the intervention group and the nurse in charge of the intervention will not be blinded because they will need to update participants and maintain the intervention and services. Interventions Participants will be required to complete the discharge assessment form before the day of discharge. After completing the discharge assessment, the participants will be randomly assigned to receive post-discharge NHLRC and standard primary care in their families. The intervention period will start immediately following randomisation and will last for a month. Patients in the NHLRC group will receive face-to-face learning of rehabilitation skills when they are discharged from the hospital. The knowledge provider is a multi-disciplinary home-based rehabilitation nursing team that is composed of advanced practice nurse (APN) engaged in professional rehabilitation of stroke, neurologists, rehabilitation doctors and physical therapists. APN will mainly conduct and supervise family rehabilitation education. Neurophysicians, rehabilitation doctors and physical therapists are mainly involved in the construction of home rehabilitation intervention content plan. All members are responsible for the adjustment and optimisation of the program content. After the assessment is completed, the patient’s current functional status will be confirmed. Based on the results, team members will recommend home-exercise items that match the patient’s motor function state. The intervention program was based on the Brunnstrom theory. We combined Brunnstrom's assessment method with limb function assessment methods such as muscle strength assessment to determine the physical function stage of the patient, and then formulated the corresponding training content based on the physical function characteristics of the stage (Table 1). The specific content of the intervention programme will be developed based on the recommendations of internationally published guidelines for rehabilitation of patients with IS [8, 20-23]. The content will have some adjustments to consider the cultural appropriateness of implementation in China. The main learning contents of patients/caregivers are as follows: how to carry out limb rehabilitation training at home? when to carry out rehabilitation training? and how to choose the most appropriate rehabilitation training content? Members of the rehabilitation nursing team should assist patients in setting rehabilitation goals and making weekly rehabilitation plans and distribute learning manuals and video learning materials to patients for review at home. The rehabilitation nursing team will conduct online follow-up of patients every other week to assess whether they have achieved short-term goals, adjust or add rehabilitation contents for patients, reconfirm the intensity of home-based training of patients, answer the questions raised by the patient during rehabilitation at home and encourage the patient to maintain rehabilitation. Patients in the two groups will receive the same basic nursing care in hospitals. In addition, the control group will be routinely given post-discharge health education, such as secondary prevention measures, medication adherence, universal guidance on the content of home care and universal rehabilitation-related information such as correct limb positioning, post-discharge precautions and medical referral-related assistance. Outcomes Outcomes will be assessed at several time points, namely, at baseline and 1, 2, 3 and 4 weeks after the intervention. The primary efficacy endpoint is patients’ physical function and caregiver-related burden. Outcomes of patients Initial personal and sociodemographic variables include age, gender, monthly income (RMB). education level (illiteracy, primary education, junior high school education, high school education, college education or above), marital status (unmarried, married, divorced, widowed), primary caregivers (wife/husband, son/daughter, parents, grandparents, grandchildren, collateral relatives, hired babysitter), hemiplegic site (left limb, right limb, both sides), stroke duration (days), body mass index (BMI) and abdominal circumference. Primary outcome variables Physical function will be evaluated by Motor Assessment Scale (MAS) and Brunnstrom assessment (BRS). MAS Patient’s motor status will be assessed using MAS [24]. The scale has eight areas of motor function including supine to side lying, supine to sitting over side of bed, balanced sitting, sitting to standing, walking, upper arm function, hand movements and advanced hand activities. Each item is scored from 0 to 6, and total scores range from 0 to 48, where a score of 48 indicates lack of motor symptoms. The scale is highly reliable, with an inter-rater correlation of 0.95 and a test–retest correlation of 0.98. This study will focus on exploring changes in patients’ overall motor function before and after the intervention; therefore, total score will be used as the primary outcome measure. BRS This scale was developed by Swedish physiotherapist Signe Brunnstrom in the 1950s. The assessment method divides patients into three groups that will be evaluated for the upper limb, lower limb and hand; each part will be divided into six stages: stage (1), flaccidity; stage (2), a little or no active movement; stage (3), movements through the synergy, no voluntary movement; stage (4), some movements out of synergy; stage (5), complex movement out of the synergy with voluntary movements; stage (6), synergy disappears and near normal [25]. The assessor will determine the current motor status of patients by observing them in completing specific movements. The scale is simple, easy to use and operable. It is also a common tool in clinical assessment of motor function in stroke patients. Secondly outcome variables: Modified Barthel Index (MBI): Barthel index is used to measure the activities of daily living (ADL) and was compiled by Mahoney and Barthel in 1965. Shah modified the index to improve the sensitivity of BI for stroke rehabilitation in 1989 and renamed it MBI-modified Barthel index [26]. This study will use the improved Chinese version of the MBI scale (C-MBI) [27]. The modified version is widely used in China and more in line with Chinese culture. It is a 10-item scale of basic ADL and focuses on self-care (personal hygiene, bathing, feeding, toilet, dressing, bowel control, bladder control) and transfer (ambulation, chair/bed transfers, stair climbing). Each item of the scale has five levels of scores, and each item is weighted differently. The total score ranges from 0 to 100. Lower scores indicate worse self-care ability and higher degree of need for care of patients. The internal consistency reliability coefficient for the MBI is 0.93. Stroke-specific Quality of Life (SS-QOL) In this study, we will use stroke-specific quality of life (SS-QOL) [28] to measure the quality of life of the participants. This scale is specifically designed for patients with stroke and has 12 domains: energy (three items), family role (three items), language use (five items), movement (six items), mood (five items), personal personality (three items), self-help activities (five items), social role (five items), thinking ability (three items), upper limb function (five items), vision (three items) and occupation–production activities (three items). It has a total of 49 items and uses a five-level scoring system (1–5 points), with the lowest score of 49 and the highest score of 245. Higher scores indicate higher quality of life. The reliability of this test is reported as an Cronbach’s α ≥ 0.73 [28]. National Institutes of Health Stroke Scale (NIHSS) NIHSS is one of the world’s most common and easy-to-administer scales for assessing the degree of neurological deficits in stroke patients [29]. It consists of 12 items, namely, consciousness, gaze, visual field, facial palsy, upper limb muscle strength, lower limb muscle strength, ataxia, sensation, speech, dysarthria, neglect and distal limb function. Each impairment is scored on an ordinal scale, ranging from 0 to 2, from 0 to 3 or from 0 to 4. Higher scores indicate more serious nerve damage, and the highest score possible is 42. Outcomes of Caregivers: Chinese version of the Modified Caregiver Strain Index (C-M-CSI) We will use the Chinese version of the Modified Caregiver Strain Index (C-M-CSI) [30] to measure caregiver-related burden. This scale contains 13 items, including financial, physical, psychological, social and personal domains. Each item is rated from 0 (No) to 2 (Yes). The total score ranges from 0 to 26 points, with higher scores indicating greater caregiver burden. Data collection Blinded assessors will collect the clinical and sociodemographic data in a case report form as well as outcome data at baseline (t0) and after the intervention (td–t4). The schedule of enrolment, intervention and assessments is presented in Fig. 2 Sample size Sample size will be calculated using PASS Software (15.0.5 version, USA) based on a previous randomised controlled trial [31] that measured changes in disability levels and life quality of people with stroke undergoing home-based rehabilitation. The sample size calculation is approximated with two-sample t-test assuming equal variance. The MAS score of the study population is the observed primary outcome indicator [31]. The mean MAS score of the control group is 29±9 points, and the MAS score of the home rehabilitation group is expected to improve by 11 points. A two-sided α of 0.05 with a desired power of 90% will be adopted. The sample size of the treatment group is N1 =23 cases, and the sample size of the control group is N2 =23 cases, considering 20% of lost visits and refusals. The final minimum number of subjects needed for the treatment and control groups is 29 cases each, for a total of at least 58 subjects to be included. Statistical analysis The classification variable will be expressed as counts with percentages, such as n (%). Data with a normal distribution will be expressed as means with standard deviation, such as mean ±SDs, while data with a non-normal distribution will be represented as medians with interquartile ranges, such as medians (IQRs). The continuous variables of normal distribution will be analysed by student t-test. For the outcomes collected at different time points, the analysis of variance of repeated measurements will be used to fit the outcomes measured at each time point. A multiple imputation model will be used to process the missing data. Additionally, statistical analyses of the baseline characteristics of participants who remain in the study and those who are lost to follow-up will also be performed to explore whether there is differential dropout. All statistical analyses will be conducted using the SPSS software (version 25.0). A two-sided p value < 0.05 will be considered significant. Data management and confidentiality All paper material will be store and locked in a designated cabinet, and the electronic data will be saved in the password-secured electronic case information system. Data will be input by dedicated research assistants and checked by supervisor. Any revisions to the original data will be documented in detail. The personal information of the participants will remain anonymous and be stored securely throughout the study. All staff in this study will always maintain the strict confidentiality of the information. No additional studies using the data collected in this trial are planned. Data monitoring A data monitoring committee (DMC) will be set up for on-site audits and quality control. The DMC will be independent from the sponsor with no conflicts of interest. Two audits will be executed: at the midpoint and at the end of the RCT. The focus was on whether enrolment, sampling, data collection, intervention, and follow-up were performed and documented in a timely manner in accordance with the study protocol. In terms of adverse events, the main adverse event of patients with motor dysfunction at home is falls[32]. This study will educate patients and caregivers on the prevention of falls in the course of family activities (if necessary, by optimizing family environmental equipment and auxiliary tools). Carry on the related drill of the fall emergency treatment to the patient and caregiver, once the fall occurs, instruct the patient to report immediately and seek medical treatment in time. According to the occurrence of adverse events, the study members met to discuss and decide whether to discontinue the participant's intervention. Dissemination The progress, completion, and publication of the results of the trial will be attributed to all the partners. The ultimate results of the trial will be reported to each participant through open access publications. To maximize dissemination, these findings will be reported in open access publications in high-impact journals, oral and poster demonstrations on home-based participatory family rehabilitation for patients with motor disorders after ischemic stroke will be conducted nationally and internationally. Discussion In China, a significant proportion of population is afflicted with ischemic stroke, but the attention paid to rehabilitation is considerably overshadowed by that given to the disease, leading to suboptimal family-community rehabilitation participation and disability recovery. A systematic review [ 33 ] involving 1704 patients has indicated that the advantages of home-based combined exercise evidently outweigh those of other simple exercise such as combined exercise and aerobic exercise, in terms of promoting stroke survivors’ social participation in the long run. Given limited resources, this home-based rehabilitation exercise for IS patients are considered as an efficient and cost-effective rehabilitation method, which should be given sufficient attention and priority consideration. Though commonly neglected, tailoring individualized rehabilitation plan according to different stages of the patients’ motor function is one of the most pivotal steps. In different areas of China, the feasibility of the model which involves caregivers in family rehabilitation for IS patients has been proved by many studies [ 34 , 35 ]. The study results indicated that this model can improve patients’ activities of daily living to varying degrees, but how to embody the individualized rehabilitation in previous home-based rehabilitation programs remains unclear. The innovation of this study lies in: (1) the research team formulates a home-based rehabilitation programme according to the stages of patients’ motor function, and helps them choose the proper program that match their own functions reasonably at home, to promote the implementation of individualized rehabilitation training; (2) under the cultural background of Chinese traditional, our study attaches importance to the vital role of caregivers in family-oriented nursing. Our team will impart knowledge and skills to both patients and caregivers simultaneously, and encourage them to make decisions that are beneficial for themselves. Previous studies [ 36 ] have probed various novel methods to intervene in the IS patients’ motor function at home, including artificial intelligence devices, interactive technology, and augmented reality. However, to extensively implement this type of rehabilitation in developing countries with vast population, consideration should be made from two aspects. On the one hand, the high price of equipment presents a financial obstacle for certain patients. On the other hand, the patients using new equipment require regular evaluation to assess the suitability, thereby increasing the expenditure of human resources in healthcare. Within the cultural context of Chinese tradition, caregiver-implemented rehabilitation remains an indispensable resource for IS patients at home, especially for those who are financially constrained and reliant on family caregiving. Although continuously updated interventions for home-based rehabilitation are available, their practical application varies due to regional cultural differences as well as multicultural collision and integration. Therefore, a more comprehensive and internationalised model of self-initiated home-based rehabilitation care should thus be developed for patients with IS and even other chronic diseases. Trial status Recruitment will begin on January 25,2024. Data collection aims to be completed in July 2024. Date and version identifier:2023.12.19-version1.0. Declarations Ethics approval and consent to participate: Ethical review approval was obtained from two centers: the Ethics Committee of Shantou University Medicine College (6 December 2023, SUMC-2023-061) and the Ethics Committee of the First Affiliated Hospital of Shantou University Medicine College （13 November 2023）. All study designs will comply with the principles of the Declaration of Helsinki. All individuals will sign written informed consent forms before participating in the RCT. Consent for publication: Not applicable. Availability of data and materials: Not applicable. Competing interests: The authors declare that they have no conflict of interest. Funding: The research does no receive financial support. Authors' contributions: JS is the Chief Investigator; she conceived the study idea and supervised the trial process at the study site. YD and JX contributed to the study design. YD drafted the manuscript. JS, QYL and YL revised the manuscript. YD, DYW, JX, and FW were responsible for participant recruitment and data collection. YD and JQZ will perform the data analysis. All authors critically reviewed the main text and approved the final manuscript. Acknowledgements: We sincerely thank every expert who gave valuable advice to this study, as well as every clinical colleague for their strong support and great efforts in the implementation of this clinical trial. We would also like to thank the participants who participated in this study for their voluntary participation and willingness to cooperate. References Qin C, et al. Signaling pathways involved in ischemic stroke: molecular mechanisms and therapeutic interventions. Signal Transduct Target Ther. 2022;7(1):215. Global. regional, and national burden of stroke and its risk factors, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. 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Validation of the Chinese version of the Modified Caregivers Strain Index among Hong Kong caregivers: an initiative of medical social workers. Health Soc Work. 2013;38(4):214–21. Rasmussen RS, et al. Stroke rehabilitation at home before and after discharge reduced disability and improved quality of life: a randomised controlled trial. Clin Rehabil. 2016;30(3):225–36. Dean C, et al. Home-based, tailored intervention for reducing falls after stroke (FAST): Protocol for a randomized trial. Int J Stroke. 2021;16(9):1053–8. Zhang Q, et al. Exercise-based interventions for post-stroke social participation: A systematic review and network meta-analysis. Int J Nurs Stud. 2020;111:103738. Chu K, et al. Feasibility of a Nurse-Trained, Family Member-Delivered Rehabilitation Model for Disabled Stroke Patients in Rural Chongqing, China. J Stroke Cerebrovasc Dis. 2020;29(12):105382. Kam Yuet Wong F et al. Effects of a transitional home-based care program for stroke survivors in Harbin, China: a randomized controlled trial . Age Ageing, 2022. 51(2). Bok SK et al. High-Tech Home-Based Rehabilitation after Stroke: A Systematic Review and Meta-Analysis . J Clin Med, 2023. 12(7). Table 1 Table 1 Description of the intervention Limb Functional status Program Delivery of intervention Motor function was assessed by Brunnstrom: at stage Ⅰ-Ⅱ Manual muscle strength assessment: grade 1-2 Body position: mainly in bed, unable to sit and stand balance Educating patients on appropriate antispasmodic positioning; Guiding the caregivers how to correctly assist the patient to turn over to meet the basic position change of the patient at home; Educating the caregivers to implement standard passive range of motion exercises for the shoulder, elbow, wrist, finger, hip, knee, and ankle joints. Members of the rehabilitation nursing team educate patients face to face; Distribute education manuals to patients (illustrated); Provide patients with specific rehabilitation training videos (for patients / caregivers to review when needed) Motor function was assessed by Brunnstrom: at stage Ⅲ Manual muscle strength assessment: grade 3 Body position: patient can sit up with assistance but was unable to maintain sitting and standing balance. Teaching patients to turn actively to the left and right and carry out repeated training； Guiding patients in the skills of moving in bed； Teaching patients to carry out passive-active movement step by step, gradually transition to active exercise； ensuring that patients master torso training (gradually transition from the hip lifting activity of both legs to the hip lifting activity of the affected side). Members of the rehabilitation nursing team educate patients face to face; Distribute education manuals to patients (illustrated); Provide patients with specific rehabilitation training videos (for patients / caregivers to review when needed); Establish contact with patients / caregivers through WeChat App. (members of the rehabilitation nursing team can timely answer patients' questions and obstacles in home implementation during the intervention) Motor function was assessed by Brunnstrom: at stage Ⅳ Manual muscle strength assessment: grade 4 Body position: patient can maintain a balanced sitting position. Instructing caregivers to carry out resistance training for patients with various repetitive tasks to increase muscle strength； Carrying out appropriate rehabilitation training related to the control of muscle spasm based on the evaluation content； Members of rehabilitation nursing team should guide patients to carry out clothing training to help patients adapt to the needs of daily life. Members of the rehabilitation nursing team educate patients face to face; Distribute education manuals to patients (illustrated); Provide patients with specific rehabilitation training videos (for patients / caregivers to review when needed); Establish contact with patients / caregivers through WeChat App. (members of the rehabilitation nursing team can timely answer patients' questions and obstacles in home implementation during the intervention) Motor function was assessed by Brunnstrom: at stage Ⅴ-Ⅵ Manual muscle strength assessment: grade 5,close to the standard muscle strength level Body position: mainly in bed, unable to sit and stand balance Considering the patients' ability of daily life, instruct the patients to carry out some fine motor training to adapt to daily activities, such as grasping, grasping, buttoning and so on. Guiding patients to carry out walking training in accordance with the current activity function. Members of the rehabilitation nursing team educate patients face to face; Distribute education manuals to patients (illustrated); Provide patients with specific rehabilitation training videos (for patients / caregivers to review when needed); Establish contact with patients / caregivers through WeChat App. (members of the rehabilitation nursing team can timely answer patients' questions and obstacles in home implementation during the intervention) Part of the daily living ability training and repetitive task walking training programs are designed as game projects to enhance the interest of the patient training process. Supplementary Files SPIRITchecklist.docx Cite Share Download PDF Status: Published Journal Publication published 14 Aug, 2024 Read the published version in Trials → Version 1 posted Editorial decision: Major revision 02 Jun, 2024 Reviewers agreed at journal 12 Apr, 2024 Reviewers invited by journal 15 Mar, 2024 Editor assigned by journal 15 Mar, 2024 First submitted to journal 21 Feb, 2024 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. 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2","display":"","copyAsset":false,"role":"figure","size":36195,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eSchedule of enrolment, intervention and assessments\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-3980686/v1/d541fcc572b89339e0a7ae0b.png"},{"id":63071029,"identity":"428ba90d-7d33-4559-9c3d-5473ff1c1e8a","added_by":"auto","created_at":"2024-08-22 20:02:58","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":447921,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3980686/v1/3d410ffb-f749-4d2e-b307-7d3c60a5e7c5.pdf"},{"id":53104016,"identity":"8dddcc9e-c195-41b0-bb62-27020a514d80","added_by":"auto","created_at":"2024-03-20 15:50:16","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":40082,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITchecklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-3980686/v1/24d396b7d614f30d0c9c5055.docx"}],"financialInterests":"","formattedTitle":"Effects of a nurse-led motor function rehabilitation training program for patients with ischemic stroke, and family caregivers: study protocol for a randomised controlled trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eBackground and rationale\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIschemic stroke (IS) refers to the ischemic and hypoxic necrosis of local brain tissues, which is an irreversible damage caused by disorder of cerebral blood supply resulting from various factors [1].\u0026nbsp;According to statistics from the Global Burden of Diseases Study (GBD) [2], over the period from 1990 to 2019, the number of stroke and stroke-related deaths has presented a year-on-year escalation, reaching 12.2 million cases on a global scale in 2019. Among 143 million cases of stroke, there are 101 million cases of stroke-related disability and 6.55 million stroke-related deaths.\u0026nbsp;Accounting for 11.6% of total deaths worldwide, stroke has been the second leading cause, among which 62.5% are attributed to ischemic stroke. Since 2015, stroke has been the major cause of death and disability in China, and \u0026nbsp;an estimated 17.8 million adults in China had experienced a stroke in 2020[3].\u003c/p\u003e\n\u003cp\u003eHemiplegia is a key sequela after the acute phase of IS [4] manifested by limb motor dysfunction [5], which has diminished the patients\u0026rsquo; daily self-care capability and affected their health both physically and mentally \u0026nbsp;[6]. Throughout the lengthy period of recovery from hemiplegia, the first 3 months after the onset of IS are recognized as the most optimal time for rehabilitation exercise \u0026nbsp;[7].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn China, most IS survivors returned home after receiving treatment for the acute phase in hospitals [8, 9], while only a small number of IS patients continued motor function rehabilitation at clinics or community hospitals after discharge. Most IS patients chose to rely on themselves managing their post-stroke life at home , because of the considerable cost of long-term rehabilitation and the underdevelopment of primary healthcare system [10].\u0026nbsp;Currently, a well-prepared rehabilitation program providing direct guidance for both IS patients and caregivers has not yet been established, which hinder the patients\u0026rsquo; self-assessment, intervention and management of physical function at home after discharge. Therefore, a scientific, individualised and affordable rehabilitation exercise program is essential to promote the recovery of the IS patients, who have limited availability to receive high-quality rehabilitation training and therapeutic support.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAfter discharge, IS patients are faced with multifaceted challenges during the process of adapting to substantial changes in post-stroke life, such as re-entering the community and playing new social role [11]. Besides IS patients, their family caregivers are also confronted with considerable challenges [12, 13]. Caregivers need to learn a proper way to take care of stroke survivors at home, making good use of information and resources to not only improve their nursing efficacy, but also strike a balance between their work, personal life and caregiving duty.\u0026nbsp;If these problems remain unresolved, the IS patients\u0026rsquo; life quality may continue declining, the risk of accidental rehospitalization may elevate, and the burden and distress of caregivers may increase. Patients have strong rehabilitation needs, and their main caregivers also have obligations to help them with rehabilitation exercises [14]. Previous researches have investigated \u0026nbsp;[15, 16] the home-based rehabilitation for IS patients, however, the main implementer is healthcare provider; So far, the caregiver-implemented rehabilitation for IS patients at home has seldom mentioned.\u003c/p\u003e\n\u003cp\u003eImpacted by the ethos of Confucianism in China, family members of the discharged IS patients are usually considered as the main caregivers, namely their spouses, offspring, siblings, and other immediate relatives, however, the knowledge and skill trainings of rehabilitation they received are limited. Researches have acknowledged the effectiveness of direct rehabilitation trainings provided by professionals, to better implement rehabilitation, professionals should pay more attention to the patient empowerment[17, 18]. Patient empowerment, which is defined as the process by which people gain confidence and power in decisions and actions that affect their health, requires patients to participate, to have knowledge, self-efficacy, and health literacy. That is, health care workers should focus on improving patients\u0026rsquo; independence, mobilising their self-confidence, empowering them to make decisions and teaching them self-assessment, rehabilitation training method selection and self-management throughout the rehabilitation process. Caregivers should also allow patients to participate as actively as possible in rehabilitation training. The crucial time for IS patients and their caregivers to master the skills in managing rehabilitation and nursing care is the post-discharge period transitioning to home from hospital [14], during which healthcare providers should offer knowledge, skill, information and emotional support to these patients and their caregivers, to ensure the continuity of rehabilitation. So far, evidence-based programs and procedures that are culturally integrated with Chinese feature have not been established, resulting in the lack of a reference for nurses to empower the discharged IS patients and their caregivers and to provide them with education related to physical function rehabilitation. Our study aims to explore whether our nurse-led, caregiver-involved, home-based rehabilitation education programme can improve the motor function outcomes of IS patient. This work also seeks to answer the following questions: Can this program improve patients\u0026apos; ability to perform daily activities? Can it enhance patients\u0026apos; quality of life?\u0026nbsp;Can it alleviate the caregiver-related burden?\u003c/p\u003e\n\u003cp\u003eThe program comprises five steps, providing a reference for healthcare providers to leverage the initiative of caregivers and encourage patients to participate in limb function rehabilitation. This program aims to\u0026nbsp;(1)\u0026nbsp;help patients identify their problems; (2) identify effect factors of patients\u0026rsquo; rehabilitation behaviour; (3)\u0026nbsp;assist patients in setting long-term goals; (4)\u0026nbsp;involve patients in the development of a home-based rehabilitation program; and (5)\u0026nbsp;evaluate the effects.\u003c/p\u003e\n\u003cp\u003eThis nurse-led, caregiver-participated and interventional study will be conducted in collaboration with experts from multidisciplines to cover all areas of the topic.\u003c/p\u003e\n\u003cp\u003eObjectives\u003c/p\u003e\n\u003cp\u003eThis work aims to conduct a randomised controlled study of a rehabilitation education programme, which is nursing team-led, caregiver-involved, healthcare provider-patient-caregiver shared, decision-made by using the Motor Assessment Scale (MAS), the Brunnstrom Assessment (BRS) and the NIHSS to determine whether it is superior to conventional rehabilitation in terms of the recovery of motor function of homebound IS patients.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eTrial design\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis study is a two-arm single-blinded randomised controlled trial of an individual limb function rehabilitation intervention (Table 1) mediated by caregivers for IS survivors at home. The study will be named as nurse-led home-based limb function rehabilitation participated by caregivers (NHLRC).\u0026nbsp;This randomised controlled trial has been registered in China Clinical Trial Registration Centre (registration number:\u0026nbsp;ChiCTR2300078798) and approved by the Institutional Review Board of the First Affiliated Hospital of Shantou University (B-2023-213). The conduct of this study will follow the Declaration of Helsinki principles and has been designed in accordance with the SPIRIT 2013 statement [19]. After the baseline assessment of the patients, the patients will be randomly assigned to the NHLRC group and the control group by using a random number table.\u003c/p\u003e\n\u003cp\u003eStudy setting\u003c/p\u003e\n\u003cp\u003eParticipants will be recruited from multiple neurology departments and rehabilitation medicine wards of hospitals to achieve the target sample size. The study will be carried out in inpatient wards for face-to-face intervention and in patients’ family and community environment for online intervention in Shantou, Guangdong Province, China.\u003c/p\u003e\n\u003cp\u003eEligibility criteria\u003c/p\u003e\n\u003cp\u003eThe inclusion criteria for patients are as follows: (1) diagnosis of ischemic cerebral apoplexy according to the international classification of diseases (ICD) definition and in conformance to the guidelines of diagnosis and treatment of acute IS in China 2018 and confirmed by craniocerebral CT or MRI; (2) NIHSS score of 15 points or less on the day of discharge; (3) stable vital signs and clear consciousness; and (4) willingness of patients and their families to cooperate.\u003c/p\u003e\n\u003cp\u003eThe exclusion criteria for patients include the following: 1) unstable vital signs or unclear consciousness; 2) inability to express language correctly due to aphasia or dysarthria; 3) NIHSS score of more than 15 on the day of discharge; and 4) presence of other serious chronic or malignant diseases.\u003c/p\u003e\n\u003cp\u003eThe inclusion criteria for caregivers are as follows: 1) adult (18 years old or older); 2) physically healthy and normal cognitive ability, living ability, language communication ability and learning ability; and 3)\u0026nbsp;primary caregiver.\u003c/p\u003e\n\u003cp\u003eThe exclusion criteria for caregivers are as follows: 1) presence of tumour and history of major surgery and severe trauma; and 2) with mental illness.\u003c/p\u003e\n\u003cp\u003eRecruitment\u003c/p\u003e\n\u003cp\u003eBasing on our defined sample size, we will recruit 58 patients from the neurology inpatient ward for a period of 3–5 months. Firstly, assessors will screen newly admitted patients with a diagnosis of IS daily through the electronic medical record system to initially identify patients for enrolment based on the inclusion and exclusion criteria. An independent research coordinator will review the information of patient and determine whether the patient meets the inclusion criteria, communicate with the patient to confirm and have the patient sign an informed consent form. Weekly meetings among study members will be organised to report on recruitment and discuss the progress to make adjustments accordingly. Recruitment time may be shortened or lengthened as appropriate depending on the recruitment situation. Recruitment will be stopped when the desired target has been reached.\u003c/p\u003e\n\u003cp\u003eParticipant withdrawal\u003c/p\u003e\n\u003cp\u003eParticipants may withdraw from the trial for any reason at any time. The researcher can withdraw participants from the study for safety purposes.\u003c/p\u003e\n\u003cp\u003eRandomisation\u003c/p\u003e\n\u003cp\u003eWe will allocate eligible participants to the intervention or control group in a 1:1 ratio through simple randomisation with IBM SPSS Statistics version 25. Random numbers will be generated by a research assistant who is not involved in recruitment, intervention allocation or outcome assessment. After collecting baseline data for each group, the research assistant will place the subgroup data in sequentially numbered, opaque sealed envelopes to inform the intervention nurse.\u003c/p\u003e\n\u003cp\u003eEvaluator blinding\u003c/p\u003e\n\u003cp\u003eA researcher who is unaware of the intervention allocation will conduct outcome assessment and data entry and analysis. However, this study is not blinded due to the nature of the intervention; that is, the interventionist and carers of patients in the intervention group and the nurse in charge of the intervention will not be blinded because they will need to update participants and maintain the intervention and services.\u003c/p\u003e\n\u003cp\u003eInterventions\u003c/p\u003e\n\u003cp\u003eParticipants will be required to complete the discharge assessment form before the day of discharge. After completing the discharge assessment, the participants will be randomly assigned to receive post-discharge NHLRC and standard primary care in their families. The intervention period will start immediately following randomisation and will last for a month.\u003c/p\u003e\n\u003cp\u003ePatients in the NHLRC group will receive face-to-face learning of rehabilitation skills when they are discharged from the hospital. The knowledge provider is a multi-disciplinary home-based rehabilitation nursing team that is\u0026nbsp;composed of advanced practice nurse (APN) engaged in professional rehabilitation of stroke, neurologists, rehabilitation doctors and physical therapists. APN will mainly conduct and supervise family rehabilitation education. Neurophysicians, rehabilitation doctors and physical therapists are mainly involved in the construction of home rehabilitation intervention content plan. All members are responsible for the adjustment and optimisation of the program content. After the assessment is completed, the patient’s current functional status will be confirmed. Based on the results, team members will recommend home-exercise items that match the patient’s motor function state.\u0026nbsp;The intervention program was based on the Brunnstrom theory. We combined Brunnstrom's assessment method with limb function assessment methods such as muscle strength assessment to determine the physical function stage of the patient, and then formulated the corresponding training content based on the physical function characteristics of the stage (Table 1). The specific content of the intervention programme will be developed based on the recommendations of internationally published guidelines for rehabilitation of patients with IS [8, 20-23]. The content will have some adjustments to consider the cultural appropriateness of implementation in China. The main learning contents of patients/caregivers are as follows: how to carry out limb rehabilitation training at home? when to carry out rehabilitation training? and how to choose the most appropriate rehabilitation training content? Members of the rehabilitation nursing team should assist patients in setting rehabilitation goals and making weekly rehabilitation plans and distribute learning manuals and video learning materials to patients for review at home.\u0026nbsp;The rehabilitation nursing team will conduct online follow-up of patients every other week to assess whether they have achieved short-term goals, adjust or add rehabilitation contents for patients, reconfirm the intensity of home-based training of patients, answer the questions raised by the patient during rehabilitation at home and encourage the patient to maintain rehabilitation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePatients in the two groups will receive the same basic nursing care in hospitals. In addition, the control group will be routinely given post-discharge health education, such as secondary prevention measures, medication adherence, universal guidance on the content of home care and universal rehabilitation-related information such as correct limb positioning, post-discharge precautions and medical referral-related assistance.\u003c/p\u003e"},{"header":"Outcomes","content":"\u003cp\u003eOutcomes will be assessed at several time points, namely,\u0026nbsp;at baseline and\u0026nbsp;1, 2, 3 and 4 weeks after the intervention. The primary efficacy endpoint is patients’ physical function and caregiver-related burden.\u003c/p\u003e\u003cp\u003eOutcomes of patients\u003c/p\u003e\u003cp\u003eInitial personal and sociodemographic variables include\u0026nbsp;age, gender, monthly income (RMB). education level (illiteracy, primary education, junior high school education, high school education, college education or above), marital status (unmarried, married, divorced, widowed), primary caregivers (wife/husband, son/daughter, parents, grandparents, grandchildren, collateral relatives, hired babysitter), hemiplegic site (left limb, right limb, both sides), stroke duration (days), body mass index (BMI) and abdominal circumference.\u003c/p\u003e\u003cp\u003e\u003cu\u003ePrimary outcome variables\u0026nbsp;\u003c/u\u003e\u003c/p\u003e\u003cp\u003ePhysical function will be evaluated by Motor Assessment Scale (MAS) and Brunnstrom assessment (BRS).\u003c/p\u003e\u003cp\u003eMAS\u003c/p\u003e\u003cp\u003ePatient’s motor status will be assessed using MAS [24]. The scale has eight areas of motor function including supine to side lying, supine to sitting over side of bed, balanced sitting, sitting to standing, walking, upper arm function, hand movements and advanced hand activities. Each item is scored from 0 to 6, and total scores range from 0 to 48, where a score of 48 indicates lack of motor symptoms. The scale is highly reliable, with an inter-rater correlation of 0.95 and a test–retest correlation of 0.98. This study will focus on exploring changes in patients’ overall motor function before and after the intervention; therefore, total score will be used as the primary outcome measure.\u003c/p\u003e\u003cp\u003eBRS\u003c/p\u003e\u003cp\u003eThis scale was developed by Swedish physiotherapist Signe Brunnstrom in the 1950s. The assessment method divides patients into three groups that will be evaluated for the upper limb, lower limb and hand; each part will be divided into six stages: stage (1), flaccidity; stage (2), a little or no active movement; stage (3), movements through the synergy, no voluntary movement; stage (4), some movements out of synergy; stage (5), complex movement out of the synergy with voluntary movements; stage (6), synergy disappears and near normal [25]. The assessor will determine the current motor status of patients by observing them in completing specific movements. The scale is simple, easy to use and operable. It is also a common tool in clinical assessment of motor function in stroke patients.\u003c/p\u003e\u003cp\u003e\u003cu\u003eSecondly outcome variables:\u003c/u\u003e\u003c/p\u003e\u003cp\u003eModified Barthel Index (MBI):\u003c/p\u003e\u003cp\u003eBarthel index is used to measure the activities of daily living (ADL) and was compiled by Mahoney and Barthel in 1965. Shah modified the index to improve the sensitivity of BI for stroke rehabilitation in 1989 and renamed it MBI-modified Barthel index [26]. This study will use the improved Chinese version of the MBI scale (C-MBI) [27].\u0026nbsp;The modified version is widely used in China and more in line with Chinese culture. It is a 10-item scale of basic ADL and focuses on self-care (personal hygiene, bathing, feeding, toilet, dressing, bowel control, bladder control) and transfer (ambulation, chair/bed transfers, stair climbing).\u0026nbsp;Each item of the scale has five levels of scores, and each item is weighted differently. The total score ranges from 0 to 100. Lower scores indicate worse self-care ability and higher degree of need for care of patients. The internal consistency reliability coefficient for the MBI is 0.93.\u003c/p\u003e\u003cp\u003eStroke-specific Quality of Life (SS-QOL)\u003c/p\u003e\u003cp\u003eIn this study, we will use\u0026nbsp;stroke-specific quality of life (SS-QOL) [28] to measure the quality of life of the participants. This scale is specifically designed for patients with stroke and has 12 domains: energy (three items), family role (three items), language use (five items), movement (six items), mood (five items), personal personality (three items), self-help activities (five items), social role (five items), thinking ability (three items), upper limb function (five items), vision (three items) and occupation–production activities (three items). It has a total of 49 items and uses a five-level scoring system (1–5 points), with the lowest score of 49 and the highest score of 245. Higher scores indicate higher quality of life. The reliability of this test is reported as an Cronbach’s α ≥ 0.73 [28].\u003c/p\u003e\u003cp\u003eNational Institutes of Health Stroke Scale (NIHSS)\u003c/p\u003e\u003cp\u003eNIHSS is one of the world’s most common and easy-to-administer scales for assessing the degree of neurological deficits in stroke patients [29]. It consists of 12 items, namely, consciousness, gaze, visual field, facial palsy, upper limb muscle strength, lower limb muscle strength, ataxia, sensation, speech, dysarthria, neglect and distal limb function. Each impairment is scored on an ordinal scale, ranging from 0 to 2, from 0 to 3 or from 0 to 4. Higher scores indicate more serious nerve damage, and the highest score possible is 42.\u003c/p\u003e\u003cp\u003eOutcomes of Caregivers:\u003c/p\u003e\u003cp\u003eChinese version of the Modified Caregiver Strain Index (C-M-CSI)\u003c/p\u003e\u003cp\u003eWe will use the Chinese version of the Modified Caregiver Strain Index\u0026nbsp;(C-M-CSI) [30] to measure caregiver-related burden. This scale contains 13 items, including financial, physical, psychological, social and personal domains. Each item is rated from 0 (No) to 2 (Yes). The total score ranges from 0 to 26 points, with higher scores indicating greater caregiver burden.\u003c/p\u003e\u003cp\u003eData collection\u0026nbsp;\u003c/p\u003e\u003cp\u003eBlinded assessors will collect the clinical and sociodemographic data in a case report form as well as outcome data at baseline (t0) and after the intervention (td–t4).\u0026nbsp;The schedule of enrolment, intervention and assessments is presented in Fig. 2\u003c/p\u003e\u003cp\u003eSample size\u003c/p\u003e\u003cp\u003eSample size will be calculated using PASS Software (15.0.5 version, USA) based on a previous randomised controlled trial [31] that measured changes in disability levels and life quality of people with stroke undergoing home-based rehabilitation. The sample size calculation is approximated with two-sample t-test assuming equal variance. The MAS score of the study population is the observed primary outcome indicator [31]. The mean MAS score of the control group is 29±9\u0026nbsp;points, and the MAS score of the home rehabilitation group is expected to improve by 11 points. A two-sided α of 0.05 with a desired power of \u0026nbsp;90% will be adopted. The sample size of the treatment group is\u003cem\u003e\u0026nbsp;N1\u003c/em\u003e=23 cases, and the sample size of the control group is \u003cem\u003eN2\u003c/em\u003e=23 cases, considering 20% of lost visits and refusals. The final minimum number of subjects needed for the treatment and control groups is 29 cases each, for a total of at least 58 subjects to be included.\u003c/p\u003e\u003cp\u003eStatistical analysis\u003c/p\u003e\u003cp\u003eThe classification variable will be expressed as counts with percentages, such as n (%). Data with a normal distribution will be expressed as means with standard deviation, such as mean ±SDs, while data with a non-normal distribution will be represented as medians with interquartile ranges, such as medians (IQRs).\u0026nbsp;The continuous variables of normal distribution will be analysed by student t-test.\u003c/p\u003e\u003cp\u003eFor the outcomes collected at different time points, the analysis of variance of repeated measurements will be used to fit the outcomes measured at each time point. A multiple imputation model will be used to process the missing data. Additionally, statistical analyses of the baseline characteristics of participants who remain in the study and those who are lost to follow-up will also be performed to explore whether there is differential dropout. All statistical analyses will be conducted using the SPSS software (version 25.0).\u0026nbsp;A two-sided \u003cem\u003ep\u003c/em\u003e value \u0026lt; 0.05 will be considered significant.\u003c/p\u003e\u003cp\u003eData management and confidentiality\u003c/p\u003e\u003cp\u003eAll paper material will be store and locked in a designated cabinet, and the electronic data will be saved in the password-secured electronic case information system. Data will be input by dedicated research assistants and checked by supervisor. Any revisions to the original data will be documented in detail. The personal information of the participants will remain anonymous and be stored securely throughout the study. All staff in this study will always maintain the strict confidentiality of the information. No additional studies using the data collected in this trial are planned.\u003c/p\u003e\u003cp\u003eData monitoring\u003c/p\u003e\u003cp\u003eA data monitoring committee (DMC) will be set up for on-site audits and quality control. The DMC will be independent from the sponsor with no conflicts of interest. Two audits will be executed: at the midpoint and at the end of the RCT.\u0026nbsp;The focus was on whether enrolment, sampling, data collection, intervention, and follow-up were performed and documented in a timely manner in accordance with the study protocol.\u0026nbsp;In terms of adverse events, the main adverse event of patients with motor dysfunction at home is falls[32]. This study will educate patients and caregivers on the prevention of falls in the course of family activities (if necessary, by optimizing family environmental equipment and auxiliary tools). Carry on the related drill of the fall emergency treatment to the patient and caregiver, once the fall occurs, instruct the patient to report immediately and seek medical treatment in time. According to the occurrence of adverse events, the study members met to discuss and decide whether to discontinue the participant's intervention.\u003c/p\u003e"},{"header":"Dissemination","content":"\u003cp\u003eThe progress, completion, and publication of the results of the trial will be attributed to all the partners. The ultimate results of the trial will be reported to each participant through open access publications. To maximize dissemination, these findings will be reported in open access publications in high-impact journals, oral and poster demonstrations on home-based participatory family rehabilitation for patients with motor disorders after ischemic stroke will be conducted nationally and internationally.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn China, a significant proportion of population is afflicted with ischemic stroke, but the attention paid to rehabilitation is considerably overshadowed by that given to the disease, leading to suboptimal family-community rehabilitation participation and disability recovery. A systematic review [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e] involving 1704 patients has indicated that the advantages of home-based combined exercise evidently outweigh those of other simple exercise such as combined exercise and aerobic exercise, in terms of promoting stroke survivors\u0026rsquo; social participation in the long run. Given limited resources, this home-based rehabilitation exercise for IS patients are considered as an efficient and cost-effective rehabilitation method, which should be given sufficient attention and priority consideration. Though commonly neglected, tailoring individualized rehabilitation plan according to different stages of the patients\u0026rsquo; motor function is one of the most pivotal steps. In different areas of China, the feasibility of the model which involves caregivers in family rehabilitation for IS patients has been proved by many studies [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e, \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e]. The study results indicated that this model can improve patients\u0026rsquo; activities of daily living to varying degrees, but how to embody the individualized rehabilitation in previous home-based rehabilitation programs remains unclear. The innovation of this study lies in: (1) the research team formulates a home-based rehabilitation programme according to the stages of patients\u0026rsquo; motor function, and helps them choose the proper program that match their own functions reasonably at home, to promote the implementation of individualized rehabilitation training; (2) under the cultural background of Chinese traditional, our study attaches importance to the vital role of caregivers in family-oriented nursing. Our team will impart knowledge and skills to both patients and caregivers simultaneously, and encourage them to make decisions that are beneficial for themselves. Previous studies [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e] have probed various novel methods to intervene in the IS patients\u0026rsquo; motor function at home, including artificial intelligence devices, interactive technology, and augmented reality. However, to extensively implement this type of rehabilitation in developing countries with vast population, consideration should be made from two aspects. On the one hand, the high price of equipment presents a financial obstacle for certain patients. On the other hand, the patients using new equipment require regular evaluation to assess the suitability, thereby increasing the expenditure of human resources in healthcare. Within the cultural context of Chinese tradition, caregiver-implemented rehabilitation remains an indispensable resource for IS patients at home, especially for those who are financially constrained and reliant on family caregiving. Although continuously updated interventions for home-based rehabilitation are available, their practical application varies due to regional cultural differences as well as multicultural collision and integration. Therefore, a more comprehensive and internationalised model of self-initiated home-based rehabilitation care should thus be developed for patients with IS and even other chronic diseases.\u003c/p\u003e "},{"header":"Trial status","content":"\u003cp\u003eRecruitment will begin on January 25,2024. Data collection aims to be completed in July 2024. Date and version identifier:2023.12.19-version1.0.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e Ethical review approval was obtained from two centers: the Ethics Committee of Shantou University Medicine College (6 December 2023, SUMC-2023-061) \u0026nbsp;and the Ethics Committee of the First Affiliated Hospital of Shantou University Medicine College （13 November 2023）. All study designs will comply with the principles of the Declaration of Helsinki. All individuals will sign written informed consent forms before participating in the RCT.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u0026nbsp;\u003c/strong\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u003c/strong\u003e Not applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e The authors declare that they have no conflict of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eThe research does no receive financial support.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' contributions:\u003c/strong\u003e JS is the Chief Investigator; she conceived the study idea and supervised the trial process at the study site. YD and JX contributed to the study design. YD drafted the manuscript. JS, QYL and YL revised the manuscript. YD, DYW, JX, and FW were responsible for participant recruitment and data collection. YD and JQZ will perform the data analysis. All authors critically reviewed the main text and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements:\u003c/strong\u003e We sincerely thank every expert who gave valuable advice to this study, as well as every clinical colleague for their strong support and great efforts in the implementation of this clinical trial. We would also like to thank the participants who participated in this study for their voluntary participation and willingness to cooperate.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eQin C, et al. Signaling pathways involved in ischemic stroke: molecular mechanisms and therapeutic interventions. 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Stroke rehabilitation at home before and after discharge reduced disability and improved quality of life: a randomised controlled trial. Clin Rehabil. 2016;30(3):225\u0026ndash;36.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDean C, et al. Home-based, tailored intervention for reducing falls after stroke (FAST): Protocol for a randomized trial. Int J Stroke. 2021;16(9):1053\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang Q, et al. Exercise-based interventions for post-stroke social participation: A systematic review and network meta-analysis. Int J Nurs Stud. 2020;111:103738.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChu K, et al. Feasibility of a Nurse-Trained, Family Member-Delivered Rehabilitation Model for Disabled Stroke Patients in Rural Chongqing, China. J Stroke Cerebrovasc Dis. 2020;29(12):105382.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKam Yuet Wong F et al. \u003cem\u003eEffects of a transitional home-based care program for stroke survivors in Harbin, China: a randomized controlled trial\u003c/em\u003e. Age Ageing, 2022. 51(2).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBok SK et al. \u003cem\u003eHigh-Tech Home-Based Rehabilitation after Stroke: A Systematic Review and Meta-Analysis\u003c/em\u003e. J Clin Med, 2023. 12(7).\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Table 1","content":"\u003cp\u003e\u003cstrong\u003eTable 1 Description of the intervention\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"576\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.52173913043478%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eLimb Functional status\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.73913043478261%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eProgram\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.73913043478261%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eDelivery of intervention\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.52173913043478%\" valign=\"top\"\u003e\n \u003cp\u003eMotor function was assessed by Brunnstrom: at stage Ⅰ-Ⅱ\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eManual muscle strength assessment: grade 1-2\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eBody position: mainly in bed, unable to sit and stand balance\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.73913043478261%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;Educating patients on appropriate antispasmodic positioning;\u003c/p\u003e\n \u003cp\u003eGuiding the caregivers how to correctly assist the patient to turn over to meet the basic position change of the patient at home;\u003c/p\u003e\n \u003cp\u003eEducating the caregivers to implement standard passive range of motion exercises for the\u0026nbsp;shoulder, elbow, wrist, finger, hip, knee, and ankle joints.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.73913043478261%\" valign=\"top\"\u003e\n \u003cp\u003eMembers of the rehabilitation nursing team educate patients face to face;\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eDistribute education manuals to patients (illustrated);\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eProvide patients with specific rehabilitation training videos (for patients / caregivers to review when needed)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.52173913043478%\" valign=\"top\"\u003e\n \u003cp\u003eMotor function was assessed by Brunnstrom: at stage Ⅲ\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eManual muscle strength assessment: grade 3\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eBody position: patient can sit up with assistance but was unable to maintain sitting and standing balance.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.73913043478261%\" valign=\"top\"\u003e\n \u003cp\u003eTeaching patients to turn actively to the left and right and carry out repeated training；\u003c/p\u003e\n \u003cp\u003eGuiding patients in the skills of moving in bed；\u003c/p\u003e\n \u003cp\u003eTeaching patients to carry out passive-active movement step by step, gradually transition to active exercise；\u003c/p\u003e\n \u003cp\u003eensuring that patients master torso training (gradually transition from the hip lifting activity of both legs to the hip lifting activity of the affected side).\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.73913043478261%\" valign=\"top\"\u003e\n \u003cp\u003eMembers of the rehabilitation nursing team educate patients face to face;\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eDistribute education manuals to patients (illustrated);\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eProvide patients with specific rehabilitation training videos (for patients / caregivers to review when needed);\u003c/p\u003e\n \u003cp\u003eEstablish contact with patients / caregivers through WeChat App. (members of the rehabilitation nursing team can timely answer patients\u0026apos; questions and obstacles in home implementation during the intervention)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.52173913043478%\" valign=\"top\"\u003e\n \u003cp\u003eMotor function was assessed by Brunnstrom: at stage Ⅳ\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eManual muscle strength assessment: grade 4\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eBody position:\u0026nbsp;patient can maintain a balanced sitting position.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.73913043478261%\" valign=\"top\"\u003e\n \u003cp\u003eInstructing caregivers to carry out resistance training for patients with various repetitive tasks to increase muscle strength；\u003c/p\u003e\n \u003cp\u003eCarrying out appropriate rehabilitation training related to the control of muscle spasm based on the evaluation content；\u003c/p\u003e\n \u003cp\u003eMembers of rehabilitation nursing team should guide patients to carry out clothing training to help patients adapt to the needs of daily life.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.73913043478261%\" valign=\"top\"\u003e\n \u003cp\u003eMembers of the rehabilitation nursing team educate patients face to face;\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eDistribute education manuals to patients (illustrated);\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eProvide patients with specific rehabilitation training videos (for patients / caregivers to review when needed);\u003c/p\u003e\n \u003cp\u003eEstablish contact with patients / caregivers through WeChat App. (members of the rehabilitation nursing team can timely answer patients\u0026apos; questions and obstacles in home implementation during the intervention)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.52173913043478%\" valign=\"top\"\u003e\n \u003cp\u003eMotor function was assessed by Brunnstrom: at stage Ⅴ-Ⅵ\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eManual muscle strength assessment: grade 5,close to the standard muscle strength level\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eBody position: mainly in bed, unable to sit and stand balance\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.73913043478261%\" valign=\"top\"\u003e\n \u003cp\u003eConsidering the patients\u0026apos; ability of daily life, instruct the patients to carry out some fine motor training to adapt to daily activities, such as grasping, grasping, buttoning and so on.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eGuiding patients to carry out walking training in accordance with the current activity function.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.73913043478261%\" valign=\"top\"\u003e\n \u003cp\u003eMembers of the rehabilitation nursing team educate patients face to face;\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eDistribute education manuals to patients (illustrated);\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eProvide patients with specific rehabilitation training videos (for patients / caregivers to review when needed);\u003c/p\u003e\n \u003cp\u003eEstablish contact with patients / caregivers through WeChat App. (members of the rehabilitation nursing team can timely answer patients\u0026apos; questions and obstacles in home implementation during the intervention)\u003c/p\u003e\n \u003cp\u003ePart of the daily living ability training and repetitive task walking training programs are designed as game projects to enhance the interest of the patient training process.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\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":true,"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":"Ischemic Stroke, Rehabilitation, Home Nursing, Caregiver, Physical function, Caregiver Burden","lastPublishedDoi":"10.21203/rs.3.rs-3980686/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3980686/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground: Both individuals and society bear a considerable burden from ischemic stroke (IS), not only do patients continue suffering from motor dysfunction after discharge from hospital, but their caregivers also undertake the principal responsibility of assisting them in reintegrating into the family and society. To better improve the IS patients’ limb function and daily life activities, their caregivers should also be involved in the training of the motor function rehabilitation during the period transitioning from hospital back home. This study mainly aims to investigate the effects of a nurse-led training for IS patients and their family caregivers on the improvement of the patients’ physical function and the burden of caregivers.\u003c/p\u003e\n\u003cp\u003eMethods/design: A randomised controlled trial with blind assessment will be conducted in hospitals and during the follow-ups at home. Fifty-eight pairs of adults diagnosed with ischemic stroke and their primary caregivers will be included. Participants will be randomly given with (1) a nurse-led, home-based motor rehabilitation training participated by caregivers (intervention group) or (2) routine self-care (control group). Both groups will receive assessment and health guidance on the day of discharge, and the intervention group will receive an additional home-based training program and supervision. These two groups will be followed up every week after discharge. The primary results are drawn from the evaluation of physical function and caregiver-related burden, and the secondary results derived from statistics of the Modified Barthel Index, Stroke-specific Quality of Life and National Institutes of Health Stroke Scale. Differences between the two groups will be measured by two-way repeated measures ANOVA, considering the data at baseline and at 1-week and 4-week follow-up after training.\u003c/p\u003e\n\u003cp\u003eDiscussion: Results may provide novel and valuable information on the effects of this culturally appropriate, caregiver-involved, and home-based rehabilitation training on the physical function of IS patients and caregiver-related burden.\u003c/p\u003e\n\u003cp\u003eTrial registration: Chinese Clinical Trial Registry (chictr.org.cn) ChiCTR2300078798. Registered on 19 December 2023.\u003c/p\u003e","manuscriptTitle":"Effects of a nurse-led motor function rehabilitation training program for patients with ischemic stroke, and family caregivers: study protocol for a randomised controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-20 15:50:11","doi":"10.21203/rs.3.rs-3980686/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2024-06-02T21:38:39+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2024-04-12T11:27:15+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-03-16T02:19:21+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-03-15T12:26:35+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2024-02-21T22:39:32+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":"512c82e4-d7ee-411e-a03e-529e628df406","owner":[],"postedDate":"March 20th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-08-22T19:31:09+00:00","versionOfRecord":{"articleIdentity":"rs-3980686","link":"https://doi.org/10.1186/s13063-024-08392-3","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2024-08-14 15:57:34","publishedOnDateReadable":"August 14th, 2024"},"versionCreatedAt":"2024-03-20 15:50:11","video":"","vorDoi":"10.1186/s13063-024-08392-3","vorDoiUrl":"https://doi.org/10.1186/s13063-024-08392-3","workflowStages":[]},"version":"v1","identity":"rs-3980686","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3980686","identity":"rs-3980686","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}