Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke chronic gait deficits virtual reality training
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.
Sites / Locations
- Sheba Medical Center, Strok Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A,
B,
Arm Description
Virtual Reality training for an overall of 18 sessions 2/week + usual care.
Usual care
Outcomes
Primary Outcome Measures
Community ambulation using Step Activity Monitor (SAM)
Gait analysis (GaitRite system) including dual task
Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform.
Timed Up and Go
Secondary Outcome Measures
Functional Reach
Four Stick Stepping Test (FSST)
3DGait Analysis system
6 minute walk
Self-induced perturbations and reaction to perturbations on platform
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00600379
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke chronic gait deficits virtual reality training
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A,
Arm Type
Experimental
Arm Description
Virtual Reality training for an overall of 18 sessions 2/week + usual care.
Arm Title
B,
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Device
Intervention Name(s)
Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).
Intervention Description
Training 2/w for 9 weeks (total 18 sessions).
Primary Outcome Measure Information:
Title
Community ambulation using Step Activity Monitor (SAM)
Time Frame
Baseline X2, post training (week 9-10), retention (week 20-24)
Title
Gait analysis (GaitRite system) including dual task
Time Frame
Baseline X2, post training (week 9-10), retention (week 20-24)
Title
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)
Title
Timed Up and Go
Time Frame
Baseline X2, post training (week 9-10), retention (week 20-24)
Secondary Outcome Measure Information:
Title
Functional Reach
Time Frame
Baseline X2, post training (week 9-10), retention (week 20-24)
Title
Four Stick Stepping Test (FSST)
Time Frame
Baseline X2, post training (week 9-10), retention (week 20-24)
Title
3DGait Analysis system
Time Frame
Baseline X2, post training (week 9-10), retention (week 20-24)
Title
6 minute walk
Time Frame
Baseline X2, post training (week 9-10), retention (week 20-24)
Title
Self-induced perturbations and reaction to perturbations on platform
Time Frame
Baseline X2, post training (week 9-10), retention (week 20-24)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Tanne, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center, Strok Center
City
Tel Hashomer
State/Province
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
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Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke
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