Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke

Study Overview
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Brief Summary
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The purpose of this study is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke.

Detailed Description
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Virtual reality (VR) systems enable the learning of simple and complex skills in a controlled virtual environment; i.e., one in which the different components (constraints) of the environment can be displayed, graded, changed and monitored in a quantitative manner. Small preliminary studies suggest that VR may be used to augment chronic stroke rehabilitation and may enhance cortical reorganization. Our aim is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke. Study design-a single center randomized controlled trial of an experimental group and a usual care group.

Official Title
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A Randomized Controlled Trial of a Virtual Reality Training Program for Ambulatory Patients With Mild-to-moderate Chronic Gait Deficits After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Stroke within 3-72 months. Mild-to-moderate residual gait deficits after the index stroke with preserved capacity for ambulation without or with an assistive device (e.g., walker, cane) or orthotics (e.g. AFO). Main exclusion Criteria: Unstable cardiac or other medical condition or aphasia, dementia or other significant neurological disease limiting ability to train.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A,<br>Virtual Reality training for an overall of 18 sessions 2/week + usual care. | Device: Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).<br>* Training 2/w for 9 weeks (total 18 sessions).<br>|
| No Intervention: B,<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Community ambulation using Step Activity Monitor (SAM) |  | Baseline X2, post training (week 9-10), retention (week 20-24) | 
| Gait analysis (GaitRite system) including dual task |  | Baseline X2, post training (week 9-10), retention (week 20-24) | 
| Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform. |  | Baseline X2, post training (week 9-10), retention (week 20-24) | 
| Timed Up and Go |  | Baseline X2, post training (week 9-10), retention (week 20-24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Reach |  | Baseline X2, post training (week 9-10), retention (week 20-24) | 
| Four Stick Stepping Test (FSST) |  | Baseline X2, post training (week 9-10), retention (week 20-24) | 
| 3DGait Analysis system |  | Baseline X2, post training (week 9-10), retention (week 20-24) | 
| 6 minute walk |  | Baseline X2, post training (week 9-10), retention (week 20-24) | 
| Self-induced perturbations and reaction to perturbations on platform |  | Baseline X2, post training (week 9-10), retention (week 20-24) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke chronic gait deficits virtual reality training