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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Other: Telerehabilitation system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>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<br>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<br>* Usual care plus home-based virtual reality telerehabilitation system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Upper limb motor control at 4 weeks | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, telerehabilitation, Stroke rehabilitation