Clinical trial NCT00600379: Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke
Official title: A Randomized Controlled Trial of a Virtual Reality Training Program for Ambulatory Patients With Mild-to-moderate Chronic Gait Deficits After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: stroke chronic gait deficits virtual reality training
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-01-25
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Community ambulation using Step Activity Monitor (SAM)
timeFrame: Baseline X2, post training (week 9-10), retention (week 20-24)
measure: Gait analysis (GaitRite system) including dual task
timeFrame: Baseline X2, post training (week 9-10), retention (week 20-24)
measure: Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform.
timeFrame: Baseline X2, post training (week 9-10), retention (week 20-24)
measure: Timed Up and Go
timeFrame: Baseline X2, post training (week 9-10), retention (week 20-24)
Secondary outcomes:
measure: Functional Reach
timeFrame: Baseline X2, post training (week 9-10), retention (week 20-24)
measure: Four Stick Stepping Test (FSST)
timeFrame: Baseline X2, post training (week 9-10), retention (week 20-24)
measure: 3DGait Analysis system
timeFrame: Baseline X2, post training (week 9-10), retention (week 20-24)
measure: 6 minute walk
timeFrame: Baseline X2, post training (week 9-10), retention (week 20-24)
measure: Self-induced perturbations and reaction to perturbations on platform
timeFrame: Baseline X2, post training (week 9-10), retention (week 20-24)
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center, Strok Center
state: Ramat Gan
Study officials:
affiliation: Sheba Medical Center
name: David Tanne, MD
role: PRINCIPAL_INVESTIGATOR
References: