Stroke
Conditions
Keywords
Virtual reality, telerehabilitation, Stroke rehabilitation
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.
Interventions
OTHERTelerehabilitation system
Usual care plus home-based virtual reality telerehabilitation system.
Sponsors
Université de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Economic evaluation at 4 weeks after intervention | at 4 weeks after intervention | Cost-effectiveness analysis (CEA) comparing the intervention with usual care |
Countries
Canada
Outcome results
None listed