• Unsupervised Therapy After Stroke in the Home Setting with a Hand Rehabilitation Device (ReHandyBot)

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ClinicalTrials.gov ID

NCT07674238

Lead Sponsor

Swiss Federal Institute of TechnologyOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

40Estimated

Last Update Posted

Jun 29, 2026Actual

Start Date

Jul 1, 2026Estimated

Primary Completion Date

May 30, 2028Estimated

Completion Date

Aug 30, 2028Estimated

Official Title

Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot): a Multicentric, Exploratory Study

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.

• Stroke

• Supervised and minimally supervised therapy with ReHandyBot
• Unsupervised therapy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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).

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Swiss Federal Institute of TechnologyOTHER

Collaborators

Kliniken ValensUNKNOWN

Rehaklinik BellikonOTHER

Rehaklinik Zihlschlacht AGOTHER

University Hospital, GenevaOTHER

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

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

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