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Clinical Trials/NCT00600379
NCT00600379
Completed
Phase 2

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

Sheba Medical Center1 site in 1 country48 target enrollmentJanuary 2008
ConditionsStroke

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Stroke
Sponsor
Sheba Medical Center
Enrollment
48
Locations
1
Primary Endpoint
Community ambulation using Step Activity Monitor (SAM)
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
October 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Community ambulation using Step Activity Monitor (SAM)

Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24)

Gait analysis (GaitRite system) including dual task

Time Frame: 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.

Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24)

Timed Up and Go

Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24)

Secondary Outcomes

  • 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))
  • 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))

Study Sites (1)

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