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

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorSwiss Federal Institute of Technology

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Supervised and minimally supervised therapy with ReHandyBot
  • Unsupervised therapy

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Swiss Federal Institute of Technology

Lead sponsor

Kliniken Valens

Collaborator

Rehaklinik Bellikon

Collaborator

Rehaklinik Zihlschlacht AG

Collaborator

University Hospital, Geneva

Collaborator