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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The ReHandyBot is a robot for hand rehabilitation after stroke. The aims of this study are (1) to investigate the feasibility of unsupervised therapy with the ReHandyBot with stroke inpatients, first in a rehabilitation clinic and then at participants' home, (2) to evaluate the usability of the ReHandyBot (user interface, implemented exercises, and gaming environment, which were adapted for independent usage), and (3) to quantify the dose of additional robotic therapy that patients perform without supervision. The study consists of two primary phases. The first is a familiarization phase performed at the clinic, where therapists teach to the participants how to perform the exercises with 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Switzerland
Clinica Hildebrand Centro di riabiliazione Brissago
RECRUITING
Brissago
Contact Information
Primary
Giada Devittori, M. Sc.
giada.devittori@hest.ethz.ch
+41 44 510 72 31
Time Frame
Start Date: 2023-11-13
Estimated Completion Date: 2026-04
Participants
Target number of participants: 15
Treatments
Experimental: Unsupervised therapy
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 learnt how to safely train with the device, they can bring the device home and train with it unsupervised. On the other hand, if participants are not capable of training without supervision, after discharge they perform unsupervised therapy at home with a booklet of exercises (i.e., without the robot).
Related Therapeutic Areas
Sponsors
Collaborators: Clinica Hildebrand Brissago
Leads: Swiss Federal Institute of Technology

This content was sourced from clinicaltrials.gov