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OpenTrials
Completed

NCT Number: NCT00600379

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sheba Medical Center, Strok Center

Tel Litwinsky, Ramat Gan, 52621, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

Primary outcomes

  1. Community ambulation using Step Activity Monitor (SAM)

    Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)

  2. Gait analysis (GaitRite system) including dual task

    Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)

  3. 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)

  4. Timed Up and Go

    Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)

Secondary outcomes

  1. Functional Reach

    Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)

  2. Four Stick Stepping Test (FSST)

    Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)

  3. 3DGait Analysis system

    Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)

  4. 6 minute walk

    Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)

  5. Self-induced perturbations and reaction to perturbations on platform

    Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 25, 2008
Registry last updated
Jun 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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