A Clinical Trial Evaluating Feasibility and Acceptability of a Brain-computer Interface for Telerehabilitation in Stroke Patients

A Clinical Trial Evaluating Feasibility and Acceptability of a Brain-computer Interface for Telerehabilitation in Stroke Patients | 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 A Clinical Trial Evaluating Feasibility and Acceptability of a Brain-computer Interface for Telerehabilitation in Stroke Patients Salem Mansour, Joshua Giles, Krishnan P.S. Nair, Rebecca Marshal, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3976596/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 24 Apr, 2025 Read the published version in Journal of NeuroEngineering and Rehabilitation → Version 1 posted 4 You are reading this latest preprint version Abstract Background: We have created a groundbreaking telerehabilitation system known as Tele BCI-FES. This innovative system merges brain-computer interface (BCI) and functional electrical stimulation (FES) technologies to rehabilitate upper limb function following a stroke. Our system pioneers the concept of allowing patients to undergo BCI therapy from the comfort of their homes, while ensuring supervised therapy and real-time adjustment capabilities. In this paper,we introduce our single-arm clinical trial, which evaluates the feasibility and acceptance of this proposed system as a telerehabilitation solution for upper extremity recovery in stroke survivors. Method: The study involved eight chronic stroke patients and their caregivers who were recruited to attend nine home-based Tele BCI-FES sessions (three sessions per week) while receiving remote support from the research team.The primary outcomes of this study were recruitment and retention rates, as well as participants perception on the adoption of technology. The secondary outcomes involved assessing improvements in upper extremity function using the Fugl-Meyer Assessment for Upper Extremity (FMA_UE) and the Leeds Arm Spasticity Impact Scale (LASIS). Results: Seven chronic stroke patients completed the home-based Tele BCI-FES sessions, with high retention (87.5%) and recruitment rates (86.7%). Although participants provided mixed feedback on setup ease, they found the system progressively easier to use, and the setup process became more efficient with continued sessions. Participants suggested modifications to enhance user experience. Following the intervention, a significant increase in FMA_UE scores was observed, with an average improvement of 3.83 points (p = 0.032). Conclusion: This study serves as a proof of concept, showcasing the feasibility and acceptability of the proposed Tele BCI-FES system for rehabilitating the upper extremities of stroke survivors. Despite the limited number of rehabilitation sessions, the substantial enhancement seen in the FMA_UE score indicates the system’s potential efficacy in upper limbrehabilitation. To further validate the efficacy of the proposed Tele BCI-FES, it is essential to conduct further research involving more extensive sample sizes and additional rehabilitation sessions. Trial registration: This clinical study is registered at clinicaltrials.gov https://clinicaltrials.gov/study/NCT05215522 under the studyidentifier (NCT05215522) and registered with the ISRCTN registryhttps://doi.org/10.1186/ISRCTN42991002 (ISRCTN42991002 Full Text Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 24 Apr, 2025 Read the published version in Journal of NeuroEngineering and Rehabilitation → Version 1 posted Editorial decision: Revision requested 27 Feb, 2024 Editor assigned by journal 27 Feb, 2024 Submission checks completed at journal 27 Feb, 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. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3976596","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":275202811,"identity":"3b1330bc-80a9-48b3-bf87-7394fcf282f6","order_by":0,"name":"Salem Mansour","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABFElEQVRIie3RMUsDMRTA8RcCzZLz1hSx9xVSukr9KncUztlNEc6Twzcp/QL9EB075gjoEpx73NIuThV0vEFseuiWUEeH/KcQ+JH3CEAo9C+j5c+B3G9ICTGrgCje3ww8hPwSWkl7Hj5qgL8ShqIn6ghJ5vXDslsVI9nWeNOtzgVnVKkdTBMQeeoicp1h82T0RL5m2EYmF5wO0noBs3EpcuUkguA6QpUtDcGWoC4uKJeaA01BXJYuYgfD5guLnlx1+G1fiT8sufMSUId5kPYE7HOWcLBEW+IZzO7SnqGeDA2pTiOcHXaR9UK+jJG/OddP5vq5ecdidGLY9rPDqeCx3m5217dJzHLpHMyT9H9kKBQKhY63ByILZAf9KSOGAAAAAElFTkSuQmCC","orcid":"","institution":"University of Sheffield","correspondingAuthor":true,"prefix":"","firstName":"Salem","middleName":"","lastName":"Mansour","suffix":""},{"id":275202812,"identity":"edabbbda-4748-42eb-b6b5-3860af5a2589","order_by":1,"name":"Joshua Giles","email":"","orcid":"","institution":"University of Sheffield","correspondingAuthor":false,"prefix":"","firstName":"Joshua","middleName":"","lastName":"Giles","suffix":""},{"id":275202813,"identity":"ce28817f-a68d-45ef-a0ef-3f6b3f471df7","order_by":2,"name":"Krishnan P.S. 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This innovative system merges brain-computer interface (BCI) and functional electrical stimulation (FES) technologies to rehabilitate upper limb function following a stroke. Our system pioneers the concept of allowing patients to undergo BCI therapy from the comfort of their homes, while ensuring supervised therapy and real-time adjustment capabilities. In this paper,we introduce our single-arm clinical trial, which evaluates the feasibility and acceptance of this proposed system as a telerehabilitation solution for upper extremity recovery in stroke survivors.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMethod: The study involved eight chronic stroke patients and their caregivers who were recruited to attend nine home-based Tele BCI-FES sessions (three sessions per week) while receiving remote support from the research team.The primary outcomes of this study were recruitment and retention rates, as well as participants perception on the adoption of technology. The secondary outcomes involved assessing improvements in upper extremity function using the Fugl-Meyer Assessment for Upper Extremity (FMA_UE) and the Leeds Arm Spasticity Impact Scale (LASIS).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eResults: Seven chronic stroke patients completed the home-based Tele BCI-FES sessions, with high retention (87.5%) and recruitment rates (86.7%). Although participants provided mixed feedback on setup ease, they found the system progressively easier to use, and the setup process became more efficient with continued sessions. Participants suggested modifications to enhance user experience. Following the intervention, a significant increase in FMA_UE scores was observed, with an average improvement of 3.83 points (p = 0.032).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConclusion: This study serves as a proof of concept, showcasing the feasibility and acceptability of the proposed Tele BCI-FES system for rehabilitating the upper extremities of stroke survivors. Despite the limited number of rehabilitation sessions, the substantial enhancement seen in the FMA_UE score indicates the system’s potential efficacy in upper limbrehabilitation. 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