START—the Swiss tele-assisted rehabilitation and training program to support transition from inpatient to outpatient care in the subacute phase after a stroke: feasibility, safety and performance evaluation
IntroductionEffective rehabilitation is essential to prevent physical and cognitive decline, but many stroke patients face challenges to maintain rehabilitation efforts after hospital discharge. Telerehabilitation, delivered via digital platforms, represents a promising approach for intensive contin...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Digital Health |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fdgth.2024.1496170/full |
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| author | Szabina Gäumann Carina Ziller Carina Ziller Nele Paulissen Nele Paulissen Frank Behrendt Frank Behrendt Zorica Suica Zorica Suica Björn Crüts Luana Gammerschlag Katrin Parmar Katrin Parmar Hans Ulrich Gerth Hans Ulrich Gerth Leo H. Bonati Leo H. Bonati Leo H. Bonati Corina Schuster-Amft Corina Schuster-Amft Corina Schuster-Amft |
| author_facet | Szabina Gäumann Carina Ziller Carina Ziller Nele Paulissen Nele Paulissen Frank Behrendt Frank Behrendt Zorica Suica Zorica Suica Björn Crüts Luana Gammerschlag Katrin Parmar Katrin Parmar Hans Ulrich Gerth Hans Ulrich Gerth Leo H. Bonati Leo H. Bonati Leo H. Bonati Corina Schuster-Amft Corina Schuster-Amft Corina Schuster-Amft |
| author_sort | Szabina Gäumann |
| collection | DOAJ |
| description | IntroductionEffective rehabilitation is essential to prevent physical and cognitive decline, but many stroke patients face challenges to maintain rehabilitation efforts after hospital discharge. Telerehabilitation, delivered via digital platforms, represents a promising approach for intensive continuation of stroke rehabilitation after discharge. The Swiss tele-assisted rehabilitation and training program (START), delivered through the Blended Clinic mobile application, seeks to support patients to start during inpatient rehabilitation, continue during the transition to the home environment, continue until outpatient rehabilitation starts and beyond. The study aims to evaluate feasibility, safety and performance of the START program on the Blended Clinic platform during inpatient, transition, and outpatient rehabilitation with patients in the early and late subacute phase after a stroke. Furthermore, patients' functional status, mobility and activity level, and health-related quality of life are monitored.MethodsThis single-center feasibility trial with three measurement sessions will include 40 patients, who will be introduced to START during their inpatient rehabilitation. Patients will continue for 12 weeks post-discharge. For the feasibility assessment, process-, training- and mHealth-related parameter will be evaluated, which include recruitment rate, process-evaluation, safety, adherence, drop-out rate, stability and maintenance of the system, usability, quality, satisfaction, user and program experience, and perceived change. Secondary outcomes will focus on motor function, mobility, quality of life, activity level, heart rate, blood pressure, and performance-based measures.DiscussionThe study's strengths include its foundation in previous usability analyses, which informed refinements to the START program. The study's design is based on the ISO 14155 standard, ensuring high standards for medical device research and supporting the future certification of the START program on the Blended Clinic platform. Potential challenges include patient self-reporting via the mobile application and barriers related to technology use among older adults and older mobile devices. Additionally, the availability of coaching is limited to business hours, which may affect adherence. Despite these challenges, the study's findings will provide insights into the feasibility of mobile-based telerehabilitation and guide the design of a future randomized controlled trial.
Clinical Trial RegistrationThe study is registered with the Swiss National Clinical Trial Portal (SNCTP000005943), EUDAMED (CIV-CH-24-05-046954), and clinicaltrils.gov (NCT06449612). |
| format | Article |
| id | doaj-art-10e4b3a304454b0d80d71f6fe5568a91 |
| institution | Kabale University |
| issn | 2673-253X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Digital Health |
| spelling | doaj-art-10e4b3a304454b0d80d71f6fe5568a912025-01-31T14:13:46ZengFrontiers Media S.A.Frontiers in Digital Health2673-253X2025-01-01610.3389/fdgth.2024.14961701496170START—the Swiss tele-assisted rehabilitation and training program to support transition from inpatient to outpatient care in the subacute phase after a stroke: feasibility, safety and performance evaluationSzabina Gäumann0Carina Ziller1Carina Ziller2Nele Paulissen3Nele Paulissen4Frank Behrendt5Frank Behrendt6Zorica Suica7Zorica Suica8Björn Crüts9Luana Gammerschlag10Katrin Parmar11Katrin Parmar12Hans Ulrich Gerth13Hans Ulrich Gerth14Leo H. Bonati15Leo H. Bonati16Leo H. Bonati17Corina Schuster-Amft18Corina Schuster-Amft19Corina Schuster-Amft20Research Department, Reha Rheinfelden, Rheinfelden, SwitzerlandResearch Department, Reha Rheinfelden, Rheinfelden, SwitzerlandPhysiotherapy Department, Reha Rheinfelden, Rheinfelden, SwitzerlandResearch Department, Reha Rheinfelden, Rheinfelden, SwitzerlandPhysiotherapy Department, Reha Rheinfelden, Rheinfelden, SwitzerlandResearch Department, Reha Rheinfelden, Rheinfelden, SwitzerlandSchool of Engineering and Computer Science, Bern University of Applied Sciences, Biel, SwitzerlandResearch Department, Reha Rheinfelden, Rheinfelden, SwitzerlandPhysiotherapy Department, Reha Rheinfelden, Rheinfelden, SwitzerlandBlended Clinic AI GmbH, Nuremberg, GermanyBlended Clinic AI GmbH, Nuremberg, GermanyResearch Department, Reha Rheinfelden, Rheinfelden, SwitzerlandTranslational Imaging in Neurology (ThINk) Basel, Departments of Head, Spine and Neuromedicine and Biomedical Engineering, University Hospital Basel and University of Basel, Basel, SwitzerlandResearch Department, Reha Rheinfelden, Rheinfelden, SwitzerlandDepartment of Medicine, University Hospital Münster, Münster, GermanyResearch Department, Reha Rheinfelden, Rheinfelden, SwitzerlandStroke Center and Department of Neurology, University Hospital Basel, Basel, SwitzerlandDepartment of Clinical Research, University of Basel, Basel, SwitzerlandResearch Department, Reha Rheinfelden, Rheinfelden, SwitzerlandSchool of Engineering and Computer Science, Bern University of Applied Sciences, Biel, SwitzerlandDepartment for Sport, Exercise and Health, University of Basel, Basel, SwitzerlandIntroductionEffective rehabilitation is essential to prevent physical and cognitive decline, but many stroke patients face challenges to maintain rehabilitation efforts after hospital discharge. Telerehabilitation, delivered via digital platforms, represents a promising approach for intensive continuation of stroke rehabilitation after discharge. The Swiss tele-assisted rehabilitation and training program (START), delivered through the Blended Clinic mobile application, seeks to support patients to start during inpatient rehabilitation, continue during the transition to the home environment, continue until outpatient rehabilitation starts and beyond. The study aims to evaluate feasibility, safety and performance of the START program on the Blended Clinic platform during inpatient, transition, and outpatient rehabilitation with patients in the early and late subacute phase after a stroke. Furthermore, patients' functional status, mobility and activity level, and health-related quality of life are monitored.MethodsThis single-center feasibility trial with three measurement sessions will include 40 patients, who will be introduced to START during their inpatient rehabilitation. Patients will continue for 12 weeks post-discharge. For the feasibility assessment, process-, training- and mHealth-related parameter will be evaluated, which include recruitment rate, process-evaluation, safety, adherence, drop-out rate, stability and maintenance of the system, usability, quality, satisfaction, user and program experience, and perceived change. Secondary outcomes will focus on motor function, mobility, quality of life, activity level, heart rate, blood pressure, and performance-based measures.DiscussionThe study's strengths include its foundation in previous usability analyses, which informed refinements to the START program. The study's design is based on the ISO 14155 standard, ensuring high standards for medical device research and supporting the future certification of the START program on the Blended Clinic platform. Potential challenges include patient self-reporting via the mobile application and barriers related to technology use among older adults and older mobile devices. Additionally, the availability of coaching is limited to business hours, which may affect adherence. Despite these challenges, the study's findings will provide insights into the feasibility of mobile-based telerehabilitation and guide the design of a future randomized controlled trial. Clinical Trial RegistrationThe study is registered with the Swiss National Clinical Trial Portal (SNCTP000005943), EUDAMED (CIV-CH-24-05-046954), and clinicaltrils.gov (NCT06449612).https://www.frontiersin.org/articles/10.3389/fdgth.2024.1496170/fulltelerehabilitationstroketrainingcoachingmonitoringfeasibility |
| spellingShingle | Szabina Gäumann Carina Ziller Carina Ziller Nele Paulissen Nele Paulissen Frank Behrendt Frank Behrendt Zorica Suica Zorica Suica Björn Crüts Luana Gammerschlag Katrin Parmar Katrin Parmar Hans Ulrich Gerth Hans Ulrich Gerth Leo H. Bonati Leo H. Bonati Leo H. Bonati Corina Schuster-Amft Corina Schuster-Amft Corina Schuster-Amft START—the Swiss tele-assisted rehabilitation and training program to support transition from inpatient to outpatient care in the subacute phase after a stroke: feasibility, safety and performance evaluation Frontiers in Digital Health telerehabilitation stroke training coaching monitoring feasibility |
| title | START—the Swiss tele-assisted rehabilitation and training program to support transition from inpatient to outpatient care in the subacute phase after a stroke: feasibility, safety and performance evaluation |
| title_full | START—the Swiss tele-assisted rehabilitation and training program to support transition from inpatient to outpatient care in the subacute phase after a stroke: feasibility, safety and performance evaluation |
| title_fullStr | START—the Swiss tele-assisted rehabilitation and training program to support transition from inpatient to outpatient care in the subacute phase after a stroke: feasibility, safety and performance evaluation |
| title_full_unstemmed | START—the Swiss tele-assisted rehabilitation and training program to support transition from inpatient to outpatient care in the subacute phase after a stroke: feasibility, safety and performance evaluation |
| title_short | START—the Swiss tele-assisted rehabilitation and training program to support transition from inpatient to outpatient care in the subacute phase after a stroke: feasibility, safety and performance evaluation |
| title_sort | start the swiss tele assisted rehabilitation and training program to support transition from inpatient to outpatient care in the subacute phase after a stroke feasibility safety and performance evaluation |
| topic | telerehabilitation stroke training coaching monitoring feasibility |
| url | https://www.frontiersin.org/articles/10.3389/fdgth.2024.1496170/full |
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