Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT06057129

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

Led by Swiss Federal Institute of Technology · Updated on 2024-11-01

15

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

Sponsors

S

Swiss Federal Institute of Technology

Lead Sponsor

C

Clinica Hildebrand Brissago

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Age between 18 and 90 years
  • Acute or subacute stroke within 12 weeks of onset
  • Pre-stroke modified Rankin score of 1 or less
  • NIH Stroke Scale score of 1 or more in motor, sensory, or ataxia items
  • Enough space at home to set up the ReHandyBot device
Not Eligible

You will not qualify if you...

  • Modified Ashworth Scale greater than 2 in shoulder, forearm, elbow, wrist, or finger muscles
  • Moderate to severe aphasia (Goodglass-Kaplan's scale less than 3)
  • Moderate to severe cognitive deficits (LCF-R less than 9)
  • Upper limb impairment due to other conditions
  • Severe pain in affected arm (VAS pain score 5 or higher)
  • Other medical conditions interfering with the study
  • Presence of pacemakers or other active implants
  • Planned discharge to assisted living or care home

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Clinica Hildebrand Centro di riabiliazione Brissago

Brissago, Canton Ticino, Switzerland, 6614

Actively Recruiting

Loading map...

Research Team

G

Giada Devittori, M. Sc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here