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

NCT ID: NCT00600379

Last Updated: 2011-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A,

Virtual Reality training for an overall of 18 sessions 2/week + usual care.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Training 2/w for 9 weeks (total 18 sessions).

B,

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Training 2/w for 9 weeks (total 18 sessions).

Intervention Type DEVICE

Eligibility Criteria

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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).

Exclusion Criteria

* Unstable cardiac or other medical condition or aphasia, dementia or other significant neurological disease limiting ability to train.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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David Tanne, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center, Strok Center

Tel Litwinsky, Ramat Gan, Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-07-4780-DT-CTIL

Identifier Type: -

Identifier Source: org_study_id

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