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StrokeRHB Home SNRNCT07674238

Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot)

A study testing Supervised and minimally supervised therapy with ReHandyBot and Unsupervised therapy in people with Stroke, run by Swiss Federal Institute of Technology at 4 sites in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Stroke
What is being tested?
Supervised and minimally supervised therapy with ReHandyBot and Unsupervised therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesSwitzerland
Study dates
1 Nov 2026to 30 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland4 sites
  • Rehaklinik Bellikon

    Bellikon, 5454

    Study coordinator, +41 44 510 72 31, giada.devittori@hest.ethz.ch

  • University Hospital, Geneva

    Geneva, 1211

    Study coordinator, +41 44 510 72 31, giada.devittori@hest.ethz.ch

  • Rehaklinik Valens

    Valens, 7317

    Study coordinator, +41 44 510 72 31, giada.devittori@hest.ethz.ch

  • Rehaklinik Zihlschlacht AG

    Zihlschlacht, 8588

    Study coordinator, +41 44 510 72 31, giada.devittori@hest.ethz.ch

Other trials in Switzerland

About this study

Official title: 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.

Conditions
Stroke
Being tested
Supervised and minimally supervised therapy with ReHandyBot, Unsupervised therapy
Keywords
Stroke, Hand impairment, Robot-assisted therapy, Unsupervised therapy, Neurorehabilitation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised and minimally supervised therapy with ReHandyBotDevice

    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.

  • Unsupervised therapyDevice

    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.

Study groups in NCT07674238
Study groupRoleWhat they receive
Unsupervised therapyExperimentalThis 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.
Receives: Device: Supervised and minimally supervised therapy with ReHandyBot; Device: Unsupervised therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose of unsupervised therapy - Minutes

    Daily dose in minutes of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.

    Measured: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).

  2. 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.

    Measured: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).

  3. 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.

    Measured: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).

Secondary outcomes (31)
  1. Feasibility - Adverse events

    Feasibility of therapy with the ReHandyBot as assessed by the number of adverse events occurring during this study.

    Measured: 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).

  2. Feasibility - Device deficiencies

    Feasibility of therapy with the ReHandyBot as assessed by the number of device deficiencies occurring during this study.

    Measured: 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).

  3. 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.

    Measured: This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).

  4. 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.

    Measured: This is calculated on completion of the study protocol, i.e., at the end of the six weeks of unsupervised therapy at home.

  5. Generalizability of unsupervised therapy with the ReHandyBot

    Generalizability is assessed by comparing the feasibility of the intervention across the four sites.

    Measured: This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).

  6. 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).

    Measured: This is measured at the end of the second week of intervention (at the end of the familiarization phase).

  7. 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).

    Measured: Usability is measured again after 8 weeks of intervention.

  8. 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).

    Measured: This is measured at the end of the second week of intervention (at the end of the familiarization phase).

  9. 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).

    Measured: Usability is measured again after 8 weeks of intervention.

  10. 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).

    Measured: This is measured at the end of the second week of intervention (at the end of the familiarization phase).

  11. 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).

    Measured: Usability is measured again after 8 weeks of intervention.

  12. 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).

    Measured: 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).

  13. 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).

    Measured: This is measured at the end of the second week of intervention (at the end of the familiarization phase).

  14. 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).

    Measured: User experience is measured again after 8 weeks of intervention.

  15. 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.

    Measured: This is calculated at the end of the study (i.e., after 8 weeks of intervention).

  16. 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).

    Measured: This is measured at the end of the second week of intervention (at the end of the familiarization phase).

  17. 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).

    Measured: User experience is measured again after 8 weeks of intervention.

  18. 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).

    Measured: This is measured at the end of the second week of intervention (at the end of the familiarization phase).

  19. 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).

    Measured: User experience is measured again after 8 weeks of intervention.

  20. 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.

    Measured: This is calculated at the end of the study (i.e., after 8 weeks of intervention).

  21. 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.

    Measured: 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).

  22. 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.

    Measured: 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).

  23. 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.

    Measured: 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).

  24. 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.

    Measured: 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).

  25. 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.

    Measured: 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).

  26. 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.

    Measured: This is calculated at the end of the study, after performing the final measurements (i.e., after 8 weeks of intervention).

  27. 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".

    Measured: 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).

  28. 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.

    Measured: 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).

  29. Content of robotic therapy - Performance

    Task performance (i.e., correct trials over total trials) during robotic therapy throughout the study.

    Measured: 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).

  30. 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.

    Measured: 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).

  31. 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).

    Measured: This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07674238
Sponsor's protocol ID
RHB Home SNR
Acronym
RHB Home SNR
Status last verified
Sep 2026
First submitted
16 Jun 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Supervised and minimally supervised therapy with ReHandyBot and Unsupervised therapy in people with Stroke, run by Swiss Federal Institute of Technology at 4 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giada Devittori, Dr. (+41 44 510 72 31, giada.devittori@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose of unsupervised therapy - Minutes (time frame: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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