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

Purpose

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.

Condition	Intervention	Phase
Stroke	Device: Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

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

Further study details as provided by Sheba Medical Center:

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 ]

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 ]

Estimated Enrollment:	48
Study Start Date:	January 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A,: Experimental Virtual Reality training for an overall of 18 sessions 2/week + usual care.	Device: Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands). Training 2/w for 9 weeks (total 18 sessions).
B,: No Intervention Usual care

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

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600379

Locations


Israel, Ramat Gan
	Sheba Medical Center, Strok Center	Recruiting
	Tel Hashomer, Ramat Gan, Israel, 52621
	Contact: David Tanne, MD PhD Phone: +972-35302069 tanne@post.tau.ac.il

Sponsors and Collaborators

Sheba Medical Center

Investigators


Principal Investigator:	David Tanne, MD	Sheba Medical Center

More Information

Responsible Party:	Sheba Medical Center ( Prof. David Tanne/Director, Stroke Center )
Study ID Numbers:	SHEBA-07-4780-DT-CTIL
First Received:	January 14, 2008
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00600379
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

stroke chronic gait deficits virtual reality training

Study placed in the following topic categories:

Cerebral Infarction

Stroke

Vascular Diseases

Brain Ischemia

Central Nervous System Diseases

Ischemia

Brain Infarction

Brain Diseases

Infarction

Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00600379