Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot) (RHB Home SNR)
2026年6月23日 更新者：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.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Giada Devittori, Dr.
- 电话号码：+41 44 510 72 31
- 邮箱：giada.devittori@hest.ethz.ch
学习地点
-
-
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Bellikon、瑞士、5454
- Rehaklinik Bellikon
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接触：
- Study coordinator
- 电话号码：+41 44 510 72 31
- 邮箱：giada.devittori@hest.ethz.ch
-
Geneva、瑞士、1211
- University Hospital, Geneva
-
接触：
- Study coordinator
- 电话号码：+41 44 510 72 31
- 邮箱：giada.devittori@hest.ethz.ch
-
Valens、瑞士、7317
- Rehaklinik Valens
-
接触：
- Study coordinator
- 电话号码：+41 44 510 72 31
- 邮箱：giada.devittori@hest.ethz.ch
-
Zihlschlacht、瑞士、8588
- Rehaklinik Zihlschlacht AG
-
接触：
- Study coordinator
- 电话号码：+41 44 510 72 31
- 邮箱：giada.devittori@hest.ethz.ch
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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无监督治疗的剂量 - 分钟
大体时间：这是在干预期间（即在家进行六周无人监督治疗期间）测量的。
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受试者在没有监督的情况下在家中进行的自我管理机器人辅助治疗的每日剂量（以分钟为单位）。
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这是在干预期间（即在家进行六周无人监督治疗期间）测量的。
|
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无监督治疗的剂量 - 重复
大体时间：这是在干预期间（即在家进行六周无人监督治疗期间）测量的。
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受试者在没有监督的情况下在家中进行的自我管理机器人辅助治疗的任务重复次数的每日剂量。
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这是在干预期间（即在家进行六周无人监督治疗期间）测量的。
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无监督治疗的剂量 - 治疗时间的百分比变化
大体时间：这是在干预期间（即在家进行六周无人监督治疗期间）测量的。
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与参与者仅进行传统（即通常规定的）治疗的情况相比，由于无人监督的机器人治疗而导致的治疗时间增加的百分比。
|
这是在干预期间（即在家进行六周无人监督治疗期间）测量的。
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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可行性 - 不良事件
大体时间：在整个方案期间（即从第一周开始到六周在家无人监督治疗结束）对此进行监测。
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根据本研究期间发生的不良事件数量评估 ReHandyBot 治疗的可行性。
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在整个方案期间（即从第一周开始到六周在家无人监督治疗结束）对此进行监测。
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可行性 - 设备缺陷
大体时间：在整个方案期间（即从第一周开始到六周在家无人监督治疗结束）对此进行监测。
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根据本研究期间发生的设备缺陷数量评估 ReHandyBot 治疗的可行性。
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在整个方案期间（即从第一周开始到六周在家无人监督治疗结束）对此进行监测。
|
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通过自定义机器人评估“aROM - 手”评估的抓取活动活动范围 (aROM) 的变化（以毫米为单位）
大体时间：这是在研究结束时进行最终测量后计算的（即六周在家无人监督治疗结束时）。
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基线之间的变化（即
研究的开始）和最终（即
研究结束）aROM 用于抓握，即用于手的张开和闭合。
这是由机器人通过自定义评估来测量的。
|
这是在研究结束时进行最终测量后计算的（即六周在家无人监督治疗结束时）。
|
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通过定制机器人评估“韦伯分数”评估触觉感知的变化，以百分比测量患者可以感知的最小刚度差异
大体时间：这是在研究结束时进行最终测量后计算的（即六周在家无人监督治疗结束时）。
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基线之间的变化（即
研究的开始）和最终（即
研究结束）触觉感知，定义为患者可以感知的最小刚度差异，根据韦伯分数定律以百分比表示。
这是由机器人使用名为“韦伯分数”的自定义评估来测量的。
|
这是在研究结束时进行最终测量后计算的（即六周在家无人监督治疗结束时）。
|
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机器人治疗的内容-性能
大体时间：在整个方案期间（即从第一周开始到六周在家无人监督治疗结束）对此进行监测。
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在整个研究过程中机器人治疗期间的任务表现（即，在总试验中的正确试验）。
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在整个方案期间（即从第一周开始到六周在家无人监督治疗结束）对此进行监测。
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机器人治疗内容-有效时间比
大体时间：在整个方案期间（即从第一周开始到六周在家无人监督治疗结束）对此进行监测。
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在整个研究期间，机器人治疗期间有效（即无休息的净总治疗时间）与治疗疗程总持续时间的比率。
|
在整个方案期间（即从第一周开始到六周在家无人监督治疗结束）对此进行监测。
|
|
影响无人监督机器人辅助治疗的参数
大体时间：这是在研究结束时计算的（即六周在家无人监督治疗结束时）。
|
获得的无人监督机器人辅助治疗剂量与筛选访视期间进行的不同参数（即认知评估（Goodglass-Kaplan 量表、LCF-R、蒙特利尔认知评估 (MoCA)）、临床评估、机器人评估、人口统计和收集的医疗数据）。
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这是在研究结束时计算的（即六周在家无人监督治疗结束时）。
|
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Feasibility - Subjects performing unsupervised robot-assisted training
大体时间：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
大体时间：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
大体时间：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)
大体时间：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).
|
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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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 BBT test.
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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 modified Ashworth Scale (mAS)
大体时间：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 mAS.
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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 proprioception as assessed by the custom robotic assessment "JND" measuring the minimum difference in hand positioning that a patient can perceive
大体时间：This is calculated at the end of the study, after performing the final measurements (i.e., after 8 weeks of intervention).
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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.
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This is calculated at the end of the study, after performing the final measurements (i.e., after 8 weeks of intervention).
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Content of robotic therapy - Intensity (repetitions of a therapy task over time)
大体时间：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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Intensity (i.e., repetitions of a therapy task over time) of the robotic therapy throughout the study.
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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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Bertrand Léger, Dr.、Responsible for research at the SUVA clinics (Bellikon and Sion)
- 首席研究员：Roman Gonzenbach, Dr. med. Dr. sc. nat.、Rehaklinik Valens
- 首席研究员：René Müri, Prof. Dr. med.、Rehaklinik Zihlschlacht AG
- 首席研究员：Mauro Silva, Dr. med.、University Hospital, Geneva
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2028年5月30日
研究完成 (估计的)
2028年8月30日
研究注册日期
首次提交
2026年6月16日
首先提交符合 QC 标准的
2026年6月23日
首次发布 (实际的)
2026年6月29日
研究记录更新
最后更新发布 (实际的)
2026年6月29日
上次提交的符合 QC 标准的更新
2026年6月23日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.