Skip to main content
OpenTrials
Completed

NCT Number: NCT02491203

Post-stroke Upper Limb Rehabilitation Using Telerehabilitation Interactive Virtual Reality System in the Patient's Home

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 (Richard, 2013) 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 a TR system that allows upper limb rehabilitation with ongoing off-line monitoring, to be used after usual poststroke rehabilitation is completed and services are no longer offered.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Montreal

Montreal, Quebec, H3N 1X7, Canada

About this study

More specifically, the objective of the proposed study is to assess the impact, in terms of motor recovery, function,quality of life, compliance, safety and cost, of a novel, patient-centered home-based tailored TR program using an affordable virtual reality system for upper-limb rehabilitation post-stroke. Such a system, combined with remote off-line monitoring could allow patients to take charge and pursue their rehabilitation beyond current services, maximizing their potential for recovery.

A single-blind two-arm randomized clinical trial (RCT) is proposed for this study with participants who have had a stroke randomly allocated to: (1) 4-week training with home-based tele-rehabilitation (TR) system (see intervention below).i.e. treatment group or (2) 4-week written home exercise program provided by a clinician, i.e. exercise control group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic or hemorrhagic stroke (does not have to be a first time stroke);
  • Mild to moderate upper limb impairment (score 3-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician);
  • At least 6 months post stroke;
  • No longer receiving rehabilitation services; and (5) 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;
  • Previous upper limb impairment limiting potential recovery.

Treatment and study plan

Telerehabilitation system

Other

Usual care plus home-based virtual reality telerehabilitation system.

Primary outcomes

  1. Change from Baseline in Upper limb motor control at 4 weeks

    Time frame: baseline and four weeks after intervention

    as measured using the Fugl-Meyer Assessment-UE (FMA-UE).

Secondary outcomes

  1. Change from Baseline in quality of life at 4 weeks

    Time frame: At intake into the study ( post-stroke; chronic phase) and four weeks after intervention

    measured using the Stroke Impact Scale-16, a stroke-specific, self-report, health status measure featuring 16 items capturing daily activities

  2. Change from Baseline in Upper limb motor control at 4 weeks

    Time frame: At intake into the study ( post-stroke; chronic phase) and four weeks after intervention

    Box and Block test.

  3. Change from Baseline in Upper limb function at 4 weeks

    Time frame: At intake into the study ( post-stroke; chronic phase) and four weeks after intervention

    Impact on upper extremity use in daily activities will be using the Motor Activity Log, a self-reported measure of upper limb use

Other outcomes

  1. Economic evaluation at 4 weeks after intervention

    Time frame: at 4 weeks after intervention

    Cost-effectiveness analysis (CEA) comparing the intervention with usual care

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Registry information

Official study title

Maximizing Post-stroke Upper Limb Rehabilitation Using a Novel Telerehabilitation Interactive Virtual Reality System in the Patient's Home

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jul 7, 2015
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.