Robot-assisted hand rehabilitation for stroke patients at home

Feasibility of Unsupervised Therapy After Stroke in the Home Setting with a Hand Rehabilitation Device (ReHandyBot): an Exploratory Study

This study tests if a robot called ReHandyBot can help stroke patients do hand rehabilitation at home on their own after some initial training in a clinic.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Swiss Federal Institute of Technology (Academic / other)
• Locations: 1 site (Brissago, Canton Ticino)
• Trial ID: NCT06057129 on ClinicalTrials.gov

What this trial studies

This study investigates the feasibility of using the ReHandyBot, a robot designed for hand rehabilitation, for unsupervised therapy in stroke patients. Initially, participants will receive supervised training in a rehabilitation clinic, where therapists will guide them on how to use the robot effectively. Once they are capable, patients will take the robot home to continue their rehabilitation independently. The study aims to evaluate the usability of the device and quantify the amount of therapy performed without supervision.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 who have experienced an acute or subacute stroke within the last 12 weeks and have mild to moderate motor impairments.

Not a fit: Patients with severe cognitive deficits, significant spasticity, or other conditions that impair upper limb function may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance rehabilitation outcomes for stroke patients by increasing the amount of therapy they receive in a home setting.

How similar studies have performed: While the use of robotic therapy for stroke rehabilitation is an emerging field, similar studies have shown promising results in enhancing therapy outcomes.

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;
* pacemakers and other active implants;
* after discharge the patient will go to an assisted living facility (e.g., care home).

Where this trial is running

Brissago, Canton Ticino

• Clinica Hildebrand Centro di riabiliazione Brissago — Brissago, Canton Ticino, Switzerland (Recruiting)

Study contacts

• Principal investigator: Paolo Rossi, Dr. med. — Clinica Hildebrand Brissago
• Study coordinator: Giada Devittori, M. Sc.

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