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Stroke Interventions in Clinical Trials
Printable Version
Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke



Principal Investigator
David Tanne, MD

PI Address
David Tanne, MD, Department of Neurology
Chaim Sheba Medical Center
Tel-Hashomer 52621, Israel.
E-mail tanne@post.tau.ac.il

Contact Email
tanne@post.tau.ac.il

Sponsor



Trial Phase:Phase II
Study Size Planned:48
Centers Planned:1
Max Time from onset:72 Months
Max Age:65
Min Age:16
Follow-up Duration:24 Weeks
ISRCTN#NCT00600379
Status:
This study is currently recruiting participants.

Purpose:
To examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke.

Interventions:
Virtual reality (VR) system
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.

Location(s):
Israel

Year Started: 2008

Design:
Interventional, Treatment, Randomized, Open Label, Parallel Assignment.

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).

Exclusion Criteria
Unstable cardiac or other medical condition or aphasia, dementia or other significant neurological disease limiting ability to train.

Patient Involvement:
Community ambulation using Step Activity Monitor (SAM), Gait analysis (GaitRite system) including dual task, Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform, Timed Up and Go, Functional Reach, Four Stick Stepping Test (FSST), 3DGait Analysis system, 6 minute walk and self-induced perturbations and reaction to perturbations on platform completed at baseline X2, post training (week 9-10), retention (week 20-24). Virtual Reality training for an overall of 18 sessions 2/week + usual care for those in the experimental arm vs usual care for those in the control arm.

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


Secondary Outcome:
Functional Reach, Four Stick Stepping Test (FSST), 3DGait Analysis system, 6 minute walk and self-induced perturbations and reaction to perturbations on platform completed at baseline X2, post training (week 9-10), retention (week 20-24).

Source of Information:
ClinicalTrials.gov

Web Links and Publications:
Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke
ClinicalTrials.gov

This information last updated on: 5/25/2010

Reviewed on: 06/01/2010.

UID: 869

   

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