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

Phase 2

Completed

• Conditions: Stroke
• Interventions: Device: Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).

• Registration Number: NCT00600379
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-24
• Study First Posted: 2008-01-25
• Primary Completion: 2010-07
• Study Completion: 2010-10
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-15
• Last Update Posted: 2011-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A,	Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).	Virtual Reality training for an overall of 18 sessions 2/week + usual care.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Sheba Medical Center, Strok Center; 🇮🇱 Tel Hashomer, Ramat Gan, Israel