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

NCT07674238 | Not Yet Recruiting DMC

• 1 other identifier: RHB Home SNR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief 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 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

Keywords

Stroke; Hand impairment; Robot-assisted therapy; Unsupervised therapy; Neurorehabilitation

Outcome Measures

Primary Outcomes (3)

• Dose of unsupervised therapy - Minutes

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

  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.

  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.

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

Secondary Outcomes (31)

• Feasibility - Adverse events

  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

  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

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

• Feasibility - Attendance

  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

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

Study Arms (1)

Unsupervised therapy

EXPERIMENTAL

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

Interventions

Supervised and minimally supervised therapy with ReHandyBot DEVICE

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 therapy

Unsupervised therapy DEVICE

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.

Unsupervised therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Kliniken Valens: collaborator
• Rehaklinik Bellikon: collaborator
• Rehaklinik Zihlschlacht AG: collaborator
• University Hospital, Geneva: collaborator

Study Sites (4)

Rehaklinik Bellikon

Bellikon, 5454, Switzerland

Location

University Hospital, Geneva

Geneva, 1211, Switzerland

Location

Rehaklinik Valens

Valens, 7317, Switzerland

Location

Rehaklinik Zihlschlacht AG

Zihlschlacht, 8588, Switzerland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bertrand Léger, Dr.

  Responsible for research at the SUVA clinics (Bellikon and Sion)

  PRINCIPAL INVESTIGATOR

• Roman Gonzenbach, Dr. med. Dr. sc. nat.

  Rehaklinik Valens

  PRINCIPAL INVESTIGATOR

• René Müri, Prof. Dr. med.

  Rehaklinik Zihlschlacht AG

  PRINCIPAL INVESTIGATOR

• Mauro Silva, Dr. med.

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giada Devittori, Dr.

CONTACT

+41 44 510 72 31; giada.devittori@hest.ethz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)