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

November 27, 2018 updated by: Dahlia Kairy, Université de Montréal

Maximizing Post-stroke Upper Limb Rehabilitation Using a Novel 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3N 1X7
        • University of Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
All study participants in the control group will receive a 4-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program.
Experimental: Telerehabilitation system
Participants in the experimental group will receive four weeks written home exercise program provided by a clinician, i.e. usual care discharge home program plus 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 the program adapted to ensure it remains at an appropriate level for the patient.
Other: Telerehabilitation system
Usual care plus home-based virtual reality telerehabilitation system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline and four weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At intake into the study ( post-stroke; chronic phase) and four weeks after intervention
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.
At intake into the study ( post-stroke; chronic phase) and four weeks after intervention
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
At intake into the study ( post-stroke; chronic phase) and four weeks after intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Economic evaluation at 4 weeks after intervention
Time Frame: at 4 weeks after intervention
Cost-effectiveness analysis (CEA) comparing the intervention with usual care
at 4 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Montréal

Investigators

  • Principal Investigator: Dahlia Kairy, PhD, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

June 13, 2015

First Submitted That Met QC Criteria

July 6, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRIR-937-0214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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