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

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00600379
First received: January 14, 2008
Last updated: June 15, 2011
Last verified: June 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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) ]
  • Gait analysis (GaitRite system) including dual task [ Time Frame: 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. [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ]
  • Timed Up and Go [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ]

Secondary Outcome Measures:
  • Functional Reach [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ]
  • Four Stick Stepping Test (FSST) [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ]
  • 3DGait Analysis system [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ]
  • 6 minute walk [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ]
  • Self-induced perturbations and reaction to perturbations on platform [ Time Frame: Baseline X2, post training (week 9-10), retention (week 20-24) ]

Estimated Enrollment: 48
Study Start Date: January 2008
Study Completion Date: October 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A,
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).
No Intervention: B,
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   (Child, Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Israel
Sheba Medical Center, Strok Center
Tel Hashomer, Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: David Tanne, MD Sheba Medical Center
  More Information

Responsible Party: Prof. David Tanne/Director, Stroke Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00600379     History of Changes
Other Study ID Numbers: SHEBA-07-4780-DT-CTIL
Study First Received: January 14, 2008
Last Updated: June 15, 2011

Keywords provided by Sheba Medical Center:
stroke chronic gait deficits virtual reality training

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2017