Post-stroke Upper Limb Rehabilitation Using Telerehabilitation Interactive Virtual Reality System in the Patient's Home
- Conditions
- Stroke
- Interventions
- Other: Telerehabilitation system
- Registration Number
- NCT02491203
- Lead Sponsor
- Université de Montréal
- 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 (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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telerehabilitation system 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.
- Primary Outcome Measures
Name Time Method Change from Baseline in Upper limb motor control at 4 weeks baseline and four weeks after intervention as measured using the Fugl-Meyer Assessment-UE (FMA-UE).
- Secondary Outcome Measures
Name Time Method Change from Baseline in quality of life at 4 weeks 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
Change from Baseline in Upper limb motor control at 4 weeks At intake into the study ( post-stroke; chronic phase) and four weeks after intervention Box and Block test.
Change from Baseline in Upper limb function at 4 weeks 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
Trial Locations
- Locations (1)
University of Montreal
🇨🇦Montreal, Quebec, Canada
University of Montreal🇨🇦Montreal, Quebec, Canada