Virtual Environment Rehabilitation for Chronic Stroke (VEHAB)
Primary Purpose
Stroke
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Commercially-Available Interactive Video Games
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Greater than 6 months following stroke
- Ability to walk 10 feet with or without assistance
- 18 years of age or older
- Clinical presentation of unilateral hemiplegia post-stroke
- Ability to follow simple two-step instructions
Exclusion Criteria:
- Unable to ambulate 150 feet prior to stroke
- History of serious chronic obstructive pulmonary disease or oxygen dependence
- Severe weight bearing pain
- Lower-extremity amputation
- Non-healing ulcers on the lower extremity
- Renal dialysis or end stage liver disease
- Legal blindness or deafness or severe visual or hearing impairment
- A history of significant psychiatric illness defined by diagnosis of bipolar affective disorder, psychosis, or schizophrenia
- Life expectancy less than one year
- Severe arthritis or orthopaedic problems that limit passive ranges of motion of lower extremity: Knee flexion contracture of -10 degrees, Knee flexion ROM < 90 degrees, hip flexion contracture > 25 degrees, ankle plantar flexion contracture > 15 degrees
- History of deep venous thrombosis or pulmonary embolism within 6 months
- Uncontrollable diabetes: diabetic coma, frequent insulin reactions
- Severe hypertension with systolic > 200mmHg and diastolic > 110mmHg at rest
- Intracranial hemorrhage related to aneurysm rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded)
- History of severe seizure disorder; other neurological conditions such as multiple sclerosis or Parkinson's Disease
- Pain that is scored greater than 5 out of 10 on a visual analog scale and limits daily activity
- Any health problems judged by their screening physician to put the client at significant risk of harm during the study
Sites / Locations
- University of South Carolina - Public Health Research Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Immediate Treatment Group
Delayed Treatment Group
Arm Description
Outcomes
Primary Outcome Measures
Balance (Berg Balance Scale)
Do determine the influence of active gaming on balance in individuals with chronic stroke
Secondary Outcome Measures
balance (Berg Balance Scale)
Determine whether the Nintendo Wii games or the Sony PlayStation 2 EyeToy a) offers superior improvement of balance
balance (Berg Balance Scale)
Determine whether individuals with low or high fall risk show greater improvements in balance following participation in an interactive video game session.
Participant Perception
Determine whether the Nintendo Wii games or the Sony PlayStation 2 EyeToy offers superior participant perception of 1) enjoyability of the game, 2) feasibility for independent use of the game, and 3) improvement in perceived mobility as a result of the game.
Full Information
NCT ID
NCT01414686
First Posted
August 8, 2011
Last Updated
April 17, 2019
Sponsor
University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT01414686
Brief Title
Virtual Environment Rehabilitation for Chronic Stroke
Acronym
VEHAB
Official Title
Commercially-Available Interactive Video Games for Individuals With Chronic Mobility and Balance Deficits Post-Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
More than half of individuals post-stroke have residual movement disabilities, including reduced mobility, balance, and increased risk of falling. There is a need for innovative, long-term and economically-feasible interventions for those with chronic stroke. Recently, a focus has been placed on the use of virtual reality and interactive gaming as a low cost and effective manner of treating movement disorders. Yet few studies have investigated interactive gaming platforms effect on balance following stroke. The proposed study is a randomized, single-blind, control group cross-over study for individuals with chronic stroke designed to examine an innovative therapeutic approach by investigating the effects of commercially-available gaming systems on balance, mobility and fear of falling in a sample of individuals with chronic motor deficits following stroke.
Detailed Description
Objective: To determine if playing active video games results in improved balance and motor performance.
Design: Randomized-matched, single-blind, control group cross-over study Setting: Laboratory Patients: Participants with chronic hemiparesis post-stroke were randomly assigned to a gaming group or normal activity control group.
Interventions: Gaming systems provided an interactive interface of real-time movement of either themselves or an avatar on the screen. Participants played games 1 hour/day, 4 days/week, for 5 weeks, totaling 20 hours of game-play. The intervention was strictly game-play without physical therapy. All games were played in standing position and trainers supervised to protect against loss of balance.
Measurements: Both groups were tested prior to and following the 5 weeks (post-test) and 3 months following the completion of the intervention/control. Outcome measures included: Fugl-Meyer Motor Exam, Single Leg Stance time, symmetrical weight bearing, Berg Balance Scale, Dynamic Gait Index, Timed Up and Go, Six Minute Walk, 3 Meter Walk, step length differential, and perception of recovery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Treatment Group
Arm Type
Experimental
Arm Title
Delayed Treatment Group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Commercially-Available Interactive Video Games
Other Intervention Name(s)
Gaming, Nintendo Wii, Playstation, Stroke
Intervention Description
Two commercially available gaming platforms were used in this study, the Nintendo Wii and the Sony PS 2. The Wii games included "Wii Sports" and "Wii Fit"; PS games included the EyeToy "Play 2" and "Kinetic". Each of these games provides multiple mini games which pose different movement challenges, including dynamic balance, speed, accuracy, general mobility, and weight shifts.
Game play was performed 1 hour/day, 4 days/ week, for a period of 5 weeks, totaling 20 hours.
Primary Outcome Measure Information:
Title
Balance (Berg Balance Scale)
Description
Do determine the influence of active gaming on balance in individuals with chronic stroke
Time Frame
change from pre to post and change from pre to follow-up (3 months)
Secondary Outcome Measure Information:
Title
balance (Berg Balance Scale)
Description
Determine whether the Nintendo Wii games or the Sony PlayStation 2 EyeToy a) offers superior improvement of balance
Time Frame
change from pre to post and change from pre to follow-up (3 months)
Title
balance (Berg Balance Scale)
Description
Determine whether individuals with low or high fall risk show greater improvements in balance following participation in an interactive video game session.
Time Frame
post (5 weeks)
Title
Participant Perception
Description
Determine whether the Nintendo Wii games or the Sony PlayStation 2 EyeToy offers superior participant perception of 1) enjoyability of the game, 2) feasibility for independent use of the game, and 3) improvement in perceived mobility as a result of the game.
Time Frame
Post test (5 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Greater than 6 months following stroke
Ability to walk 10 feet with or without assistance
18 years of age or older
Clinical presentation of unilateral hemiplegia post-stroke
Ability to follow simple two-step instructions
Exclusion Criteria:
Unable to ambulate 150 feet prior to stroke
History of serious chronic obstructive pulmonary disease or oxygen dependence
Severe weight bearing pain
Lower-extremity amputation
Non-healing ulcers on the lower extremity
Renal dialysis or end stage liver disease
Legal blindness or deafness or severe visual or hearing impairment
A history of significant psychiatric illness defined by diagnosis of bipolar affective disorder, psychosis, or schizophrenia
Life expectancy less than one year
Severe arthritis or orthopaedic problems that limit passive ranges of motion of lower extremity: Knee flexion contracture of -10 degrees, Knee flexion ROM < 90 degrees, hip flexion contracture > 25 degrees, ankle plantar flexion contracture > 15 degrees
History of deep venous thrombosis or pulmonary embolism within 6 months
Uncontrollable diabetes: diabetic coma, frequent insulin reactions
Severe hypertension with systolic > 200mmHg and diastolic > 110mmHg at rest
Intracranial hemorrhage related to aneurysm rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded)
History of severe seizure disorder; other neurological conditions such as multiple sclerosis or Parkinson's Disease
Pain that is scored greater than 5 out of 10 on a visual analog scale and limits daily activity
Any health problems judged by their screening physician to put the client at significant risk of harm during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy L Fritz, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina - Public Health Research Building
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.sph.sc.edu/dpt/dpt-rehab/vehab.htm
Description
University of South Carolina Rehabilitation Lab Website
Learn more about this trial
Virtual Environment Rehabilitation for Chronic Stroke
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