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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 14, 2008

Last Updated Date

July 9, 2008

Start Date ^†

January 2008

Current Primary Outcome Measures ^†

Community ambulation using Step Activity Monitor (SAM) [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ] [ Designated as safety issue: No ]
Gait analysis (GaitRite system) including dual task [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Timed Up and Go [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00600379 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Functional Reach [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ] [ Designated as safety issue: No ]
Four Stick Stepping Test (FSST) [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ] [ Designated as safety issue: No ]
3DGait Analysis system [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ] [ Designated as safety issue: No ]
6 minute walk [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ] [ Designated as safety issue: No ]
Self-induced perturbations and reaction to perturbations on platform [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Parallel Assignment

Condition ^†

Stroke

Intervention ^†

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

Study Arms / Comparison Groups

Experimental: Virtual Reality training for an overall of 18 sessions 2/week + usual care.
No Intervention: Usual care

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Completion Date

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

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.

Gender

Both

Ages

16 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00600379

Responsible Party

Prof. David Tanne/Director, Stroke Center, Sheba Medical Center

Secondary IDs ^††

Study Sponsor ^†

Sheba Medical Center

Collaborators ^††

Investigators ^†

Principal Investigator:

David Tanne, MD

Sheba Medical Center

Information Provided By

Sheba Medical Center

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.