Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot) (RHB Home SNR)
2026년 6월 23일 업데이트: Swiss Federal Institute of Technology
Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot): a Multicentric, Exploratory Study
The ReHandyBot (RHB) is a robot for hand rehabilitation after stroke.
The aims of this study are to investigate (i) the generalizability of unsupervised therapy with the ReHandyBot within patients' home after discharge from a clinic, (ii) compliance, as measured by the amount of unsupervised robot-assisted therapy dose (e.g., therapy time) performed by the subjects after discharge, (iii) the usability of ReHandyBot and user experience during robot-assisted therapy, and (iv) the effect of the increase in therapy dose achieved with our device compared to standard care.
The study consists of two primary phases.
The first is a familiarization phase conducted at the clinic, where therapists teach participants how to perform the exercises using the robot.
Then, if capable of training with the robot safely, after discharge from the clinic, participants can bring the robot home and autonomously train with it.
The hypothesis is that unsupervised therapy might be a possible way to increase therapy dose for stroke patients, with the potential to further improve recovery of hand function, with minimal additional burden for therapists and for the healthcare system.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Giada Devittori, Dr.
- 전화번호: +41 44 510 72 31
- 이메일: giada.devittori@hest.ethz.ch
연구 장소
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Bellikon, 스위스, 5454
- Rehaklinik Bellikon
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연락하다:
- Study coordinator
- 전화번호: +41 44 510 72 31
- 이메일: giada.devittori@hest.ethz.ch
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Geneva, 스위스, 1211
- University Hospital, Geneva
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연락하다:
- Study coordinator
- 전화번호: +41 44 510 72 31
- 이메일: giada.devittori@hest.ethz.ch
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Valens, 스위스, 7317
- Rehaklinik Valens
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연락하다:
- Study coordinator
- 전화번호: +41 44 510 72 31
- 이메일: giada.devittori@hest.ethz.ch
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Zihlschlacht, 스위스, 8588
- Rehaklinik Zihlschlacht AG
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연락하다:
- Study coordinator
- 전화번호: +41 44 510 72 31
- 이메일: giada.devittori@hest.ethz.ch
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Informed Consent signed by the subject;
- female and male patients between 18 and 90 years old;
- acute/subacute stroke (recruitment within 12 weeks from stroke onset);
- pre-stroke modified Rankin score ≤ 1;
- National Institutes of Health Stroke Scale (NIHSS) ≥ 1 in at least one of the items regarding motor functions, sensory functions and ataxia;
- possibility (e.g., enough space) to set up the ReHandyBot at home.
Exclusion Criteria:
- modified Ashworth Scale > 2 for one or more of the following muscles: shoulder adductors, forearm pronator and supinator, flexors and extensors of elbow, wrist and fingers;
- moderate to severe aphasia: Goodglass-Kaplan's scale < 3;
- moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) < 9;
- functional impairment of the upper limb due to other pathologies;
- severe pain in the affected arm: visual analogue scale for pain (VASp) ≥ 5;
- other pathologies which may interfere with the study;
- after discharge the patient will go to an assisted living facility (e.g., care home).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Unsupervised therapy
This group will perform therapy with the ReHandyBot first with the supervision of a therapist at the rehabilitation clinic.
Then, after discharge, if the participant has learned how to safely train with the device, they can bring the device home and train with it unsupervised.
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During the familiarization phase at the rehabilitation clinics, participants perform one week of supervised and one week of minimally supervised therapy with the ReHandyBot under the supervision of a supervisor (i.e., therapist or researcher).
Minimally supervised therapy means that participants try to perform therapy with the device themselves, while the supervisor is still present but helps only if participants encounter problems or have questions.
During the supervised and minimally supervised phases (first 2 weeks), the intervention consists of 5 sessions of approximately 30 minutes each per week.
These sessions are performed in addition to the conventional therapy plan.
During each session, the robot proposes a set of different exercises targeting the upper limb.
After the familiarization phase, participants train without supervision at the clinic until discharge and then at home for six weeks.
If the therapist thinks that the participant has properly learned how to use the device and can train with it safely, the participant can keep training with the device unsupervised (both at the clinic and at home).
If participants are not ready for unsupervised therapy with the device, they stop the study at the end of the familiarization phase.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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감독되지 않은 치료의 복용량 - 분
기간: 이는 개입 중에(즉, 집에서 감독 없이 치료를 받는 6주 동안) 측정됩니다.
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감독 없이 집에서 피험자가 수행하는 자가 투여 로봇 보조 요법의 일일 투여량(분)입니다.
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이는 개입 중에(즉, 집에서 감독 없이 치료를 받는 6주 동안) 측정됩니다.
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감독되지 않은 치료의 복용량 - 반복
기간: 이는 개입 중에(즉, 집에서 감독 없이 치료를 받는 6주 동안) 측정됩니다.
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감독 없이 가정 환경에서 피험자가 수행한 자가 투여 로봇 보조 치료의 작업 반복 횟수에 대한 일일 복용량입니다.
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이는 개입 중에(즉, 집에서 감독 없이 치료를 받는 6주 동안) 측정됩니다.
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감독되지 않은 치료의 복용량 - 치료 시간의 백분율 변화
기간: 이는 개입 중에(즉, 집에서 감독 없이 치료를 받는 6주 동안) 측정됩니다.
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참가자가 기존(즉, 일반적으로 처방된) 치료만 수행하는 경우에 비해 감독되지 않은 로봇 치료로 인해 치료 시간이 백분율로 증가합니다.
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이는 개입 중에(즉, 집에서 감독 없이 치료를 받는 6주 동안) 측정됩니다.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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타당성 - 부작용
기간: 이는 전체 프로토콜 기간 동안 모니터링됩니다(즉, 집에서 감독되지 않은 치료의 첫 주 시작부터 6주 종료까지).
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본 연구 기간 동안 발생한 부작용의 수를 기준으로 평가한 ReHandyBot 치료의 타당성.
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이는 전체 프로토콜 기간 동안 모니터링됩니다(즉, 집에서 감독되지 않은 치료의 첫 주 시작부터 6주 종료까지).
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타당성 - 장치 결함
기간: 이는 전체 프로토콜 기간 동안 모니터링됩니다(즉, 집에서 감독되지 않은 치료의 첫 주 시작부터 6주 종료까지).
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이 연구 중에 발생하는 장치 결함의 수에 따라 평가된 ReHandyBot을 사용한 치료의 타당성.
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이는 전체 프로토콜 기간 동안 모니터링됩니다(즉, 집에서 감독되지 않은 치료의 첫 주 시작부터 6주 종료까지).
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맞춤형 로봇 평가 "aROM - Hand"로 평가한 대로 밀리미터 단위로 측정된 잡기를 위한 활성 동작 범위(aROM)의 변화
기간: 이는 최종 측정을 수행한 후 연구가 끝날 때(즉, 집에서 감독 없이 6주간의 치료가 끝난 후) 계산됩니다.
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기준선 간 변경(예:
연구 시작) 및 최종(예:
연구 종료) 잡기 위한 aROM, 즉 손을 열고 닫는 데 사용됩니다.
이는 맞춤형 평가를 통해 로봇에 의해 측정됩니다.
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이는 최종 측정을 수행한 후 연구가 끝날 때(즉, 집에서 감독 없이 6주간의 치료가 끝난 후) 계산됩니다.
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환자가 인지할 수 있는 강성의 최소 차이를 백분율로 측정하는 맞춤형 로봇 평가 "웨버 분수(Weber Fraction)"로 평가한 촉각 인식의 변화
기간: 이는 최종 측정을 수행한 후 연구가 끝날 때(즉, 집에서 감독 없이 6주간의 치료가 끝난 후) 계산됩니다.
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기준선 간 변경(예:
연구 시작) 및 최종(예:
연구 종료) 웨버 분수 법칙에 따라 백분율로 표현되어 환자가 인지할 수 있는 강성의 최소 차이로 정의되는 햅틱 인지.
이는 "Weber Fraction"이라는 사용자 정의 평가를 사용하여 로봇에 의해 측정됩니다.
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이는 최종 측정을 수행한 후 연구가 끝날 때(즉, 집에서 감독 없이 6주간의 치료가 끝난 후) 계산됩니다.
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로봇치료 내용 - 성능
기간: 이는 전체 프로토콜 기간 동안 모니터링됩니다(즉, 집에서 감독되지 않은 치료의 첫 주 시작부터 6주 종료까지).
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연구 전반에 걸쳐 로봇 치료 중 작업 수행(즉, 전체 시도에 대한 올바른 시도).
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이는 전체 프로토콜 기간 동안 모니터링됩니다(즉, 집에서 감독되지 않은 치료의 첫 주 시작부터 6주 종료까지).
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로봇치료 내용 - 유효시간비율
기간: 이는 전체 프로토콜 기간 동안 모니터링됩니다(즉, 집에서 감독되지 않은 치료의 첫 주 시작부터 6주 종료까지).
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연구 전반에 걸쳐 로봇 치료 중 치료 세션의 총 기간에 대한 효과적인 비율(즉, 휴식이 없는 총 총 치료 시간)입니다.
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이는 전체 프로토콜 기간 동안 모니터링됩니다(즉, 집에서 감독되지 않은 치료의 첫 주 시작부터 6주 종료까지).
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감독되지 않은 로봇 보조 치료에 영향을 미치는 매개변수
기간: 이는 연구가 끝날 때(즉, 집에서 감독 없이 6주간의 치료가 끝날 때) 계산됩니다.
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달성된 감독되지 않은 로봇 보조 치료 용량과 스크리닝 방문, 임상 평가, 로봇 평가, 인구통계 및 통계 중에 수행된 다양한 매개변수(예: 인지 평가(Goodglass-Kaplan Scale, LCF-R, Montreal Cognitive Assessment(MoCA)) 사이의 상관관계 수집된 의료 데이터).
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이는 연구가 끝날 때(즉, 집에서 감독 없이 6주간의 치료가 끝날 때) 계산됩니다.
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Feasibility - Subjects performing unsupervised robot-assisted training
기간: This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
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Feasibility of unsupervised therapy with the ReHandyBot as assessed by the number of subjects who can transition to unsupervised robot-assisted therapy at home out of the total number of tested subjects.
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This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
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Feasibility - Attendance
기간: This is calculated on completion of the study protocol, i.e., at the end of the six weeks of unsupervised therapy at home.
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Feasibility of unsupervised therapy with the ReHandyBot as assessed by attendance during the unsupervised phase at home.
Attendance is measured as the percentage of days where the subject trains at least once without supervision out of the 42 days offered for unsupervised training at home.
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This is calculated on completion of the study protocol, i.e., at the end of the six weeks of unsupervised therapy at home.
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Generalizability of unsupervised therapy with the ReHandyBot
기간: This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
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Generalizability is assessed by comparing the feasibility of the intervention across the four sites.
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This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
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Usability as assessed by the System Usability Scale (1)
기간: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability of the ReHandyBot measured with the System Usability Scale.
The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).
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This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability as assessed by the System Usability Scale (2)
기간: Usability is measured again after 8 weeks of intervention.
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Usability of the ReHandyBot measured with the System Usability Scale.
The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).
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Usability is measured again after 8 weeks of intervention.
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Usability as assessed by the raw NASA Task Load Index (1)
기간: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability of the ReHandyBot measured with the raw NASA (National Aeronautics and Space Administration) Task Load Index.
Answers range from 0 (low task load) to 100 (high task load).
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This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability as assessed by the raw NASA Task Load Index (2)
기간: Usability is measured again after 8 weeks of intervention.
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Usability of the ReHandyBot measured with the raw NASA (National Aeronautics and Space Administration) Task Load Index.
Answers range from 0 (low task load) to 100 (high task load).
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Usability is measured again after 8 weeks of intervention.
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Usability as assessed by the Post-Study System Usability Questionnaire (1)
기간: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability of the ReHandyBot measured with the Post-Study System Usability Questionnaire (version 3).
This questionnaire consists of 16 questions and the possible response options vary between 1 (strongly agree) and 7 (strongly disagree).
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This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability as assessed by the Post-Study System Usability Questionnaire (2)
기간: Usability is measured again after 8 weeks of intervention.
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Usability of the ReHandyBot measured with the Post-Study System Usability Questionnaire (version 3).
This questionnaire consists of 16 questions and the possible response options vary between 1 (strongly agree) and 7 (strongly disagree).
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Usability is measured again after 8 weeks of intervention.
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Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale
기간: This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
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A 5-point scale is presented by the robot at the end of each therapy session to measure patient's satisfaction with robot-assisted therapy.
The scale ranges from 1 (low satisfaction) to 5 (high satisfaction).
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This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
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Usability - Intrinsic Motivation Inventory (1)
기간: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability of the gaming environment is measured with the Intrinsic Motivation Inventory (items: Interest/Enjoyment).
The possible response options vary between 1 (not true at all) and 7 (completely true).
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This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability - Intrinsic Motivation Inventory (2)
기간: User experience is measured again after 8 weeks of intervention.
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Usability of the gaming environment is measured with the Intrinsic Motivation Inventory (items: Interest/Enjoyment).
The possible response options vary between 1 (not true at all) and 7 (completely true).
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User experience is measured again after 8 weeks of intervention.
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Change in usability
기간: This is calculated at the end of the study (i.e., after 8 weeks of intervention).
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Change in usability between the first and second time when it is measured.
This change is used to define how the absence of the therapist during robot-assisted therapy impacts the perceived usability of the device.
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This is calculated at the end of the study (i.e., after 8 weeks of intervention).
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User experience - Customer Satisfaction Score (1)
기간: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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The Customer Satisfaction Score consists of the question "Overall, how satisfied are you with the therapy with ReHandyBot?".
The possible response options vary between 1 (extremely dissatisfied) and 5 (extremely satisfied).
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This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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User experience - Customer Satisfaction Score (2)
기간: User experience is measured again after 8 weeks of intervention.
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The Customer Satisfaction Score consists of the question "Overall, how satisfied are you with the therapy with ReHandyBot?".
The possible response options vary between 1 (extremely dissatisfied) and 5 (extremely satisfied).
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User experience is measured again after 8 weeks of intervention.
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User experience - Net Promoter Score (1)
기간: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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The Net Promoter Score consists of the question "How likely would you be to recommend therapy with ReHandyBot to another patient?".
The possible response options vary between 1 (extremely unlikely) and 10 (extremely likely).
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This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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User experience - Net Promoter Score (2)
기간: User experience is measured again after 8 weeks of intervention.
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The Net Promoter Score consists of the question "How likely would you be to recommend therapy with ReHandyBot to another patient?".
The possible response options vary between 1 (extremely unlikely) and 10 (extremely likely).
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User experience is measured again after 8 weeks of intervention.
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Change in the user experience
기간: This is calculated at the end of the study (i.e., after 8 weeks of intervention).
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Change in user experience between the first and second time when it is measured.
This change is used to define how the absence of the therapist during robot assisted therapy impacts user experience when training with the device.
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This is calculated at the end of the study (i.e., after 8 weeks of intervention).
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Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE)
기간: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
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Change between midterm (i.e., at discharge from the clinic) and final (i.e., end of the study) upper limb functions as assessed by the FMA-UE.
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This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
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Change in upper limb functions as assessed by the ABILHAND
기간: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
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Change between midterm (i.e., at discharge from the clinic) and final (i.e.
end of the study) upper limb functions as assessed by the ABILHAND scale.
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This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
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Change in upper limb functions as assessed by the Box and Block (BBT) test
기간: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
|
Change between midterm (i.e., at discharge from the clinic) and final (i.e.
end of the study) upper limb functions as assessed by the BBT test.
|
This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
|
|
Change in upper limb functions as assessed by the modified Ashworth Scale (mAS)
기간: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
|
Change between midterm (i.e., at discharge from the clinic) and final (i.e., end of the study) upper limb functions as assessed by the mAS.
|
This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
|
|
Change in proprioception as assessed by the custom robotic assessment "JND" measuring the minimum difference in hand positioning that a patient can perceive
기간: This is calculated at the end of the study, after performing the final measurements (i.e., after 8 weeks of intervention).
|
Change between baseline (i.e.
beginning of the study) and final (i.e.
end of the study) proprioception, defined as the minimum difference in the hand position that a patient can perceive (i.e.
just noticeable difference).
This is measured by the robot with a custom assessment.
|
This is calculated at the end of the study, after performing the final measurements (i.e., after 8 weeks of intervention).
|
|
Content of robotic therapy - Intensity (repetitions of a therapy task over time)
기간: This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
|
Intensity (i.e., repetitions of a therapy task over time) of the robotic therapy throughout the study.
|
This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Bertrand Léger, Dr., Responsible for research at the SUVA clinics (Bellikon and Sion)
- 수석 연구원: Roman Gonzenbach, Dr. med. Dr. sc. nat., Rehaklinik Valens
- 수석 연구원: René Müri, Prof. Dr. med., Rehaklinik Zihlschlacht AG
- 수석 연구원: Mauro Silva, Dr. med., University Hospital, Geneva
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2028년 5월 30일
연구 완료 (추정된)
2028년 8월 30일
연구 등록 날짜
최초 제출
2026년 6월 16일
QC 기준을 충족하는 최초 제출
2026년 6월 23일
처음 게시됨 (실제)
2026년 6월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 23일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .