An interventional study of Supervised and minimally supervised therapy with ReHandyBot and Unsupervised therapy in Stroke, sponsored by Swiss Federal Institute of Technology. Not yet recruiting at 4 sites in Switzerland. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Other
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 40 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Swiss Federal Institute of Technology is the lead sponsor of 154 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Supervised and minimally supervised therapy with ReHandyBot · Device: Unsupervised therapy
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.
Dose of unsupervised therapy - Minutes
Daily dose in minutes of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.
Time frame: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Dose of unsupervised therapy - Repetitions
Daily dose in number of task repetitions of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.
Time frame: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Dose of unsupervised therapy - Percentual change in therapy time
Percentage increase in therapy time due to the unsupervised robotic therapy compared to the case where the participants would perform conventional (i.e., normally prescribed) therapy only.
Time frame: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Feasibility - Adverse events
Feasibility of therapy with the ReHandyBot as assessed by the number of adverse events occurring during this study.
Time frame: 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).
Feasibility - Device deficiencies
Feasibility of therapy with the ReHandyBot as assessed by the number of device deficiencies occurring during this study.
Time frame: 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).
Feasibility - Subjects performing unsupervised robot-assisted training
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.
Time frame: This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
Feasibility - Attendance
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.
Time frame: This is calculated on completion of the study protocol, i.e., at the end of the six weeks of unsupervised therapy at home.
Generalizability of unsupervised therapy with the ReHandyBot
Generalizability is assessed by comparing the feasibility of the intervention across the four sites.
Time frame: This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
Usability as assessed by the System Usability Scale (1)
Usability of the ReHandyBot measured with the System Usability Scale. The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).
Time frame: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
Usability as assessed by the System Usability Scale (2)
Usability of the ReHandyBot measured with the System Usability Scale. The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).
Time frame: Usability is measured again after 8 weeks of intervention.
Usability as assessed by the raw NASA Task Load Index (1)
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).
Time frame: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
Usability as assessed by the raw NASA Task Load Index (2)
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).
Time frame: Usability is measured again after 8 weeks of intervention.
Usability as assessed by the Post-Study System Usability Questionnaire (1)
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).
Time frame: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
Usability as assessed by the Post-Study System Usability Questionnaire (2)
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).
Time frame: Usability is measured again after 8 weeks of intervention.
Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale
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).
Time frame: 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).
Usability - Intrinsic Motivation Inventory (1)
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).
Time frame: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
Usability - Intrinsic Motivation Inventory (2)
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).
Time frame: User experience is measured again after 8 weeks of intervention.
Change in usability
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.
Time frame: This is calculated at the end of the study (i.e., after 8 weeks of intervention).
User experience - Customer Satisfaction Score (1)
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).
Time frame: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
User experience - Customer Satisfaction Score (2)
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).
Time frame: User experience is measured again after 8 weeks of intervention.
User experience - Net Promoter Score (1)
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).
Time frame: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
User experience - Net Promoter Score (2)
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).
Time frame: User experience is measured again after 8 weeks of intervention.
Change in the user experience
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.
Time frame: This is calculated at the end of the study (i.e., after 8 weeks of intervention).
Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE)
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.
Time frame: 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 ABILHAND
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.
Time frame: 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 Box and Block (BBT) test
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.
Time frame: 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)
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.
Time frame: 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 the active Range of Motion (aROM) for grasping measured in millimeters as assessed by the custom robotic assessment "aROM - Hand"
Change between baseline (i.e. beginning of the study) and final (i.e. end of the study) aROM for grasping, i.e. for hand opening and closing. This is measured by the robot with a custom assessment.
Time frame: 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
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.
Time frame: This is calculated at the end of the study, after performing the final measurements (i.e., after 8 weeks of intervention).
Change in haptic perception as assessed by the custom robotic assessment "Weber Fraction" measuring the minimum difference in stiffness that a patient can perceive in percentage
Change between baseline (i.e. beginning of the study) and final (i.e. end of the study) haptic perception, defined as the minimum difference in stiffness that a patient can perceive expressed in percentage according to the Weber Fraction law . This is measured by the robot with a custom assessment named "Weber fraction".
Time frame: 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).
Content of robotic therapy - Intensity (repetitions of a therapy task over time)
Intensity (i.e., repetitions of a therapy task over time) of the robotic therapy throughout the study.
Time frame: 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).
Content of robotic therapy - Performance
Task performance (i.e., correct trials over total trials) during robotic therapy throughout the study.
Time frame: 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).
Content of robotic therapy - Effective time ratio
Ratio of effective (i.e., net total therapy time without breaks) over total duration of the therapy session during robotic therapy throughout the study.
Time frame: 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).
Parameters influencing unsupervised robot-assisted therapy
Correlation between achieved unsupervised robot-assisted therapy dose and different parameters (i.e., cognitive assessments (Goodglass-Kaplan Scale, LCF-R, Montreal Cognitive Assessment (MoCA)) performed during the screening visit, the clinical assessments, the robotic assessments, demographics and the collected medical data).
Time frame: This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).
Plan to share: No
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