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      Systematic Development of the ReWin Application: A Digital Therapeutic Rehabilitation Innovation for People With Stroke-related Disabilities in India

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          Abstract

          This is a viewpoint paper that aims to describe the systematic approach to the development of a technology-driven stroke rehabilitation innovation to manage disabilities following a stroke at home in India. This paper intends to sensitize public health innovators and intervention development experts about the important aspects that need to be considered to develop a culturally sensitive, patient-centered, scalable solution for stroke care using technology. Stroke has been the second-leading cause of death and the third-leading cause of disability globally for the past 3 decades. The emerging technological innovations for stroke care were predominantly designed and developed by digital technology experts as stand-alone products with very minimal efforts to explore their feasibility, acceptability, and, more importantly, scalability. Hence, a digital therapeutic rehabilitation innovation for people with stroke-related disabilities in India was systematically developed and is being evaluated. ReWin is an innovation that is technologically driven and envisions digital therapeutics as a medium for the provision of rehabilitation to persons with disabilities. It is conceptualized and developed based on the International Classification of Functioning, Disability and Health. ReWin encompasses specific technological aspects to enable its scientific framework and conceptualization to suit the context and needs of stroke care providers and consumers. The framework is built with 2 separate applications, one for the providers and one for the patients and caregivers. Each of these applications has a specific inbuilt design to add data about the demographic details of the user, stroke severity using the National Institute of Health Stroke Scale, and self-assessment of disability measured by the modified Barthel Index. Users can communicate with each other and decide on their therapeutic goals, therapy training information, and progress remotely from where they are. The ultimate outcome expected from the ReWin innovation is a continuum of care for stroke survivors that is effective, safe, and of good quality. Systematic development cannot make the intervention scalable. The intervention needs to be evaluated for its feasibility, acceptability, and effectiveness. Currently, ReWin is being evaluated for its feasibility and acceptability. The evaluation of ReWin will provide an opportunity to develop a scalable solution for empowering therapists and persons with disabilities, in general, to objectively self-manage their treatment. Findings from this study will also provide valuable information about the resources required to deliver such interventions in resource-constrained settings like India.

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          Most cited references25

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          A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance

          The UK Medical Research Council’s widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.
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            Telerehabilitation services for stroke

            Telerehabilitation offers an alternate way of delivering rehabilitation services. Information and communication technologies are used to facilitate communication between the healthcare professional and the patient in a remote location. The use of telerehabilitation is becoming more viable as the speed and sophistication of communication technologies improve. However, it is currently unclear how effective this model of delivery is relative to rehabilitation delivered face‐to‐face or when added to usual care. To determine whether the use of telerehabilitation leads to improved ability to perform activities of daily living amongst stroke survivors when compared with (1) in‐person rehabilitation (when the clinician and the patient are at the same physical location and rehabilitation is provided face‐to‐face); or (2) no rehabilitation or usual care. Secondary objectives were to determine whether use of telerehabilitation leads to greater independence in self‐care and domestic life and improved mobility, balance, health‐related quality of life, depression, upper limb function, cognitive function or functional communication when compared with in‐person rehabilitation and no rehabilitation. Additionally, we aimed to report on the presence of adverse events, cost‐effectiveness, feasibility and levels of user satisfaction associated with telerehabilitation interventions. We searched the Cochrane Stroke Group Trials Register (June 2019), the Cochrane Central Register of Controlled Trials (the Cochrane Library , Issue 6, 2019), MEDLINE (Ovid, 1946 to June 2019), Embase (1974 to June 2019), and eight additional databases. We searched trial registries and reference lists. Randomised controlled trials (RCTs) of telerehabilitation in stroke. We included studies that compared telerehabilitation with in‐person rehabilitation or no rehabilitation. In addition, we synthesised and described the results of RCTs that compared two different methods of delivering telerehabilitation services without an alternative group. We included rehabilitation programmes that used a combination of telerehabilitation and in‐person rehabilitation provided that the greater proportion of intervention was provided via telerehabilitation. Two review authors independently identified trials on the basis of prespecified inclusion criteria, extracted data and assessed risk of bias. A third review author moderated any disagreements. The review authors contacted investigators to ask for missing information. We used GRADE to assess the quality of the evidence and interpret findings. We included 22 trials in the review involving a total of 1937 participants. The studies ranged in size from the inclusion of 10 participants to 536 participants, and reporting quality was often inadequate, particularly in relation to random sequence generation and allocation concealment. Selective outcome reporting and incomplete outcome data were apparent in several studies . Study interventions and comparisons varied, meaning that, in many cases, it was inappropriate to pool studies. Intervention approaches included post‐hospital discharge support programs, upper limb training, lower limb and mobility retraining and communication therapy for people with post‐stroke language disorders. Studies were either conducted upon discharge from hospital or with people in the subacute or chronic phases following stroke. Primary outcome: we found moderate‐quality evidence that there was no difference in activities of daily living between people who received a post‐hospital discharge telerehabilitation intervention and those who received usual care (based on 2 studies with 661 participants (standardised mean difference (SMD) ‐0.00, 95% confidence interval (CI) ‐0.15 to 0.15)). We found low‐quality evidence of no difference in effects on activities of daily living between telerehabilitation and in‐person physical therapy programmes (based on 2 studies with 75 participants: SMD 0.03, 95% CI ‐0.43 to 0.48). Secondary outcomes: we found a low quality of evidence that there was no difference between telerehabilitation and in‐person rehabilitation for balance outcomes (based on 3 studies with 106 participants: SMD 0.08, 95%CI ‐0.30 to 0.46). Pooling of three studies with 569 participants showed moderate‐quality evidence that there was no difference between those who received post‐discharge support interventions and those who received usual care on health‐related quality of life (SMD 0.03, 95% CI ‐0.14 to 0.20). Similarly, pooling of six studies (with 1145 participants) found moderate‐quality evidence that there was no difference in depressive symptoms when comparing post‐discharge tele‐support programs with usual care (SMD ‐0.04, 95% CI ‐0.19 to 0.11). We found no difference between groups for upper limb function (based on 3 studies with 170 participants: mean difference (MD) 1.23, 95% CI ‐2.17 to 4.64, low‐quality evidence) when a computer program was used to remotely retrain upper limb function in comparison to in‐person therapy. Evidence was insufficient to draw conclusions on the effects of telerehabilitation on mobility or participant satisfaction with the intervention. No studies evaluated the cost‐effectiveness of telerehabilitation; however, five of the studies reported health service utilisation outcomes or costs of the interventions provided within the study. Two studies reported on adverse events, although no serious trial‐related adverse events were reported. While there is now an increasing number of RCTs testing the efficacy of telerehabilitation, it is hard to draw conclusions about the effects as interventions and comparators varied greatly across studies. In addition, there were few adequately powered studies and several studies included in this review were at risk of bias. At this point, there is only low or moderate‐level evidence testing whether telerehabilitation is a more effective or similarly effective way to provide rehabilitation. Short‐term post‐hospital discharge telerehabilitation programmes have not been shown to reduce depressive symptoms, improve quality of life, or improve independence in activities of daily living when compared with usual care. Studies comparing telerehabilitation and in‐person therapy have also not found significantly different outcomes between groups, suggesting that telerehabilitation is not inferior. Some studies reported that telerehabilitation was less expensive to provide but information was lacking about cost‐effectiveness. Only two trials reported on whether or not any adverse events had occurred; these trials found no serious adverse events were related to telerehabilitation. The field is still emerging and more studies are needed to draw more definitive conclusions. In addition, while this review examined the efficacy of telerehabilitation when tested in randomised trials, studies that use mixed methods to evaluate the acceptability and feasibility of telehealth interventions are incredibly valuable in measuring outcomes. Telerehabilitation services for stroke Review question 
 This review aimed to gather evidence for the use of telerehabilitation after stroke. We aimed to compare telerehabilitation with therapy delivered face‐to‐face and with no therapy (usual care). Background 
 Stroke is a common cause of disability in adults. After a stroke, it is common for the individual to have difficulty managing everyday activities such as walking, showering, dressing, and participating in community activities. Many people need rehabilitation after stroke; this is usually provided by healthcare professionals in a hospital or clinic setting. Recent studies have investigated whether it is possible to use technologies such as the telephone or the Internet to help people communicate with healthcare professionals without having to leave their home. This approach, which is called telerehabilitation, may be a more convenient and less expensive way of providing rehabilitation. Telerehabilitation may be used to improve a range of outcomes including physical functioning and mood. Study characteristics 
 We searched for studies in June 2019 and identified 22 studies involving 1937 people after stroke. The studies used a wide range of treatments, including therapy programmes designed to improve arm function and ability to walk and programmes designed to provide counselling and support for people upon leaving hospital after stroke. Key results 
 As the studies were very different, it was rarely appropriate to combine results to determine overall effect. We found that people who received telerehabilitation had similar outcomes for activities of daily living function to those that received face‐to‐face therapy and those that received no therapy (usual care). At this point, not enough research has been done to show whether telerehabilitation is a more effective way to provide rehabilitation. Some studies report that telerehabilitation is less expensive to provide but information is lacking about cost‐effectiveness. Only two trials reported on whether or not any adverse events had occurred; these trials found no serious adverse events were related to telerehabilitation. Further trials are required. Quality of the evidence 
 The quality of the evidence was generally of low or moderate quality. The quality of the evidence for each outcome was limited due to small numbers of study participants and poor reporting of study details.
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              Tele-Rehabilitation after Stroke: An Updated Systematic Review of the Literature

              Background Tele-rehabilitation for stroke survivors has emerged as a promising intervention for remotely supervised administration of physical, occupational, speech and other forms of therapies aimed at improving motor, cognitive and neuropsychiatric deficits from stroke. Objective To provide an updated systematic review on the efficacy of tele-rehabilitation interventions for recovery from motor, higher cortical dysfunction and post-stroke depression among stroke survivors. Methods We searched PubMed and Cochrane library from January 1, 1980 to July 15, 2017 using the following keywords: Telerehabilitation stroke”, “Mobile health rehabilitation”, “Telemedicine stroke rehabilitation”, Telerehabilitation. Our inclusion criteria were randomized controlled trials, pilot or feasibility trials that included an intervention group that received any tele-rehabilitation therapy for stroke survivors compared with a control group on usual or standard of care. Results This search yielded 49 abstracts. By consensus between two investigators, 22 publications met the criteria for inclusion and further review. Tele-rehabilitation interventions focused on motor recovery (n=18), depression or caregiver strain (n=2) and higher cortical dysfunction (n=2). Overall, tele-rehabilitation interventions were associated with significant improvements in recovery from motor deficits, higher cortical dysfunction and depression in the intervention groups in all studies assessed but significant differences between intervention versus control groups were reported in 8 out of 22 studies in favor of tele-rehabilitation group while the remaining studies reported non-significant differences. Conclusion This updated systematic review provides evidence to suggest that tele-rehabilitation interventions have either better or equal salutary effects on motor, higher cortical and mood disorders compared with conventional face-to-face therapy.
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                Author and article information

                Contributors
                Journal
                JMIR Rehabil Assist Technol
                JMIR Rehabil Assist Technol
                JRAT
                JMIR Rehabilitation and Assistive Technologies
                JMIR Publications (Toronto, Canada )
                2369-2529
                Oct-Dec 2022
                24 November 2022
                : 9
                : 4
                : e40374
                Affiliations
                [1 ] Department of Social Work Education and Community Wellbeing Faculty of Health and Life Sciences Northumbria University Newcastle Upon Tyne United Kingdom
                [2 ] South Asia Centre for Disability Inclusive Development and Research Indian Institute of Public Health Hyderabad Public Health Foundation of India Hyderabad India
                [3 ] Department of mHealth Design and Development InGage Technologies Pvt, Ltd Chennai India
                [4 ] Neurological Rehabilitation Department Chennai Advanced Rehabilitation Centre Chennai India
                Author notes
                Corresponding Author: Sureshkumar Kamalakannan sureshkumar.kamalakannan@ 123456northumbria.ac.uk
                Author information
                https://orcid.org/0000-0001-6970-4952
                https://orcid.org/0000-0003-3228-4565
                https://orcid.org/0000-0002-4138-4632
                https://orcid.org/0000-0003-0412-8442
                Article
                v9i4e40374
                10.2196/40374
                9732759
                36422867
                73d966a1-3909-4e1e-8c37-3e4058609f8a
                ©Sureshkumar Kamalakannan, Vijay Karunakaran, Ashwin Balaji Kaliappan, Ramakumar Nagarajan. Originally published in JMIR Rehabilitation and Assistive Technology (https://rehab.jmir.org), 24.11.2022.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Rehabilitation and Assistive Technology, is properly cited. The complete bibliographic information, a link to the original publication on https://rehab.jmir.org/, as well as this copyright and license information must be included.

                History
                : 17 June 2022
                : 17 August 2022
                : 12 October 2022
                : 28 October 2022
                Categories
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                stroke,telerehabilitation,neurological rehabilitation,disability,india,rehabilitation,recovery,stroke care,patient care,digital technology,feasibility,acceptability,digital therapy

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