Recruiting

Telerehabilitation

Sponsor:

Université de Montréal

Code:

NCT03759106

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

home written exercise program

telerehabilitation/exergame system

Study Details

Brief summary:

Stroke is a leading cause of death and long-term disability worldwide and its incidence is on the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a significant long-term impact on activities of daily living, leisure activities and work. The capacity for recovery following a stroke depends on several factors, including the extent of the initial neurological damage, spontaneous recovery and rehabilitation, with possible recovery even years after the stroke. Unfortunately, accessibility of much needed rehabilitation services poststroke often remains limited, both in terms of intensity and duration, as reported in a recent report on post-stroke rehabilitation services in Quebec. Recent evidence suggests that homebased telerehabilitation (TR) is a viable approach for upper limb training post-stroke when rehabilitation services are not available. Similarly, the Canadian Best Practice Recommendations for Stroke Care update for 2013 recommends home-based patient monitoring be used when frequent monitoring is needed and face-to-face visits are not available. Hence, the investigators have developed and propose to examine the use of the VirTele system for people who have suffered a stroke who are no longer receiving rehabilitation services The VirTele system allows upper limb rehabilitation using exergames with ongoing off-line monitoring combined with online monitoring and coaching based on the self-determination theory.

Conditions

Stroke

Study ID

NCT03759106

Start date

Jun 27, 2019

Status verified date

Nov, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

May, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke (does not have to be a first time stroke);
  • Mild to moderate upper limb impairment (score 2-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician);
  • No longer receiving rehabilitation services;
  • living in an area where high speed Internet access is available.

Exclusion Criteria:

  • Being medically unstable;
  • Severe cognitive or communication deficits;
  • Visual impairments;
  • Severe balance deficits limiting sitting safely independently;
  • Shoulder pain limiting movements for the game;
  • Previous upper limb impairment limiting potential recovery.

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: No Intervention: Usual care

All study participants in the control group will receive an 8-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program.

experimental: Experimental: Telerehabilitation system

Participants in the experimental group will receive 8 weeks home exercise program using a virtual reality (VR) and telerehabilitation system. The intensity and choice of game for the home program will be determined by the therapist based on the patient's abilities, interests, motivation and fatigue. The patient's performance for the VR home program will be monitored asynchronously and synchronously and the program adapted to ensure it remains at an appropriate level for the patient.

Interventions

home written exercise program

exercises such as picking up objects, placing objects, frequently prescribed at discharge

telerehabilitation/exergame system

Video games using the Kinect camera that are carried out using the impaired arm and monitored by a therapist by videoconferencing

Primary outcome measure

  • Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE) [ Time Frame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up ]

Central Contacts and Locations

Central contacts

Locations

Université de Montréal

Recruiting

Montréal, Quebec, Canada, H3N 1X7

Contacts

Dorra Allegue, MSc

dorra.allegue@umontreal.ca

Alejandro Hernandez, MSc

alejandro.hernandez@mail.mcgill.ca

More Information

Sponsor

Université de Montréal

Last update posted

Nov 14, 2022

Last verified

Nov, 2022

Keywords

  • Virtual reality
  • telerehabilitation
  • Stroke rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Montréal on 2022-11-14.