- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01735981
The Effect of Video Game Exercise on Dynamic Balance and Gait in Individuals With Huntington's Disease
July 15, 2021 updated by: Anne Kloos
The Effect of Video Game Biofeedback Modulated Exercise (ViBE)on Dynamic Balance and Gait in Individuals With Huntington's Disease
To examine the benefits of using a video-game, Dance, Dance, Revolution, as an exercise modality to improve gait and balance in individuals with Huntington's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary purpose of this study was to determine the effectiveness of a therapist-guided Video-game Biofeedback Modulated Exercise (ViBE) program administered via Dance Dance Revolution to improve dynamic balance, gait and mobility in individuals with Huntington's Disease.
Secondary aims were to explore whether the ViBE intervention would improve quality of life, fall risk, and neuropsychological functions.
The investigators hypothesized that the video-game program would lead to greater improvements in walking, dynamic balance, quality of life, fall risk, and neuropsychological function than a control handheld video game program.
Since motivation is essential to the long-term maintenance of an exercise program the investigators were also interested in finding out how successful people with Huntington's Disease were at playing Dance Dance Revolution, what their perceptions were of playing the game, and whether they thought that it was beneficial
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Atwell Hall
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adults 18 - 79 with a diagnosis of Huntington's disease
Exclusion Criteria:
- cannot walk 10 feet without assistance, any other neurologic condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: video game exercise
Video game exercise using Dance Dance Revolution
|
use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance
Other Names:
hand-held video games
|
|
OTHER: control
hand-held video game control
|
use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance
Other Names:
hand-held video games
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait Parameters
Time Frame: 6 weeks
|
utilized GAITRite to obtain spatiotemporal measures of gait: forward velocity.
|
6 weeks
|
|
Gait Parameters
Time Frame: 6 weeks
|
utilized GAITRite to obtain spatiotemporal measures of gait: forward stride length.
|
6 weeks
|
|
Gait Parameters
Time Frame: 6 weeks
|
utilized GAITRite to obtain spatiotemporal measures of gait: forward swing percent.
|
6 weeks
|
|
Gait Parameters
Time Frame: 6 weeks
|
utilized GAITRite to obtain spatiotemporal measures of gait: forward double support percent.
|
6 weeks
|
|
Gait Parameters
Time Frame: 6 weeks
|
utilized GAITRite to obtain spatiotemporal measures of gait: forward heel to heel base of support.
|
6 weeks
|
|
Gait Parameters
Time Frame: 6 weeks
|
utilized GAITRite to obtain spatiotemporal measures of gait: backwards velocity.
|
6 weeks
|
|
Gait Parameters
Time Frame: 6 weeks
|
utilized GAITRite to obtain spatiotemporal measures of gait: backwards stride length.
|
6 weeks
|
|
Gait Parameters
Time Frame: 6 weeks
|
utilized GAITRite to obtain spatiotemporal measures of gait: backwards swing percent.
|
6 weeks
|
|
Gait Parameters
Time Frame: 6 weeks
|
utilized GAITRite to obtain spatiotemporal measures of gait: backwards double support percent.
|
6 weeks
|
|
Gait Parameters
Time Frame: 6 weeks
|
utilized GAITRite to obtain spatiotemporal measures of gait: backwards heel to heel base of support.
|
6 weeks
|
|
Gait Parameters
Time Frame: 6 weeks
|
utilized GAITRite to obtain spatiotemporal measures of gait: obstacle velocity.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tinetti Mobility Test
Time Frame: 6 weeks
|
Observation of gait and balance with quantifiable 16-item assessment with an ordinal scale of 0-2 for up to a total score of 32, with higher scores indicating better performance.
It is reliable and predicts falls among those with Parkinson's disease and Huntington's disease.
|
6 weeks
|
|
Four Square Step Test
Time Frame: 6 weeks
|
Examines ability to step over an object in multiple directions and is timed.
Participants are instructed to step over a cane into each square in a specific order.
Faster times indicate better balance.
It has been shown to predict falls in the elderly.
|
6 weeks
|
|
Activities-Specific Balance Confidence Scale
Time Frame: 6 weeks
|
Individuals rate their balance confidence from 1-100 on 16 tasks and total score is the mean; higher scores indicate greater confidence and lower fall risk.
The Activities-Specific Balance Confidence Scale is reliable and valid in elderly and neurological populations.
|
6 weeks
|
|
World Health Organization Quality of Life
Time Frame: post intervention and post hand-held game, each lasts 6 weeks
|
This questionnaire is a measure of quality of life addressing 4 domains including physical, psychological, social, and environment health.
Responses on 26 items are on a five-point scale (from 1 = very dissatisfied to 5 = very satisfied) and each item is added to achieve a total score for each domain.
The mean score for each domain is calculated then multiplied by 4 to get the domain score which are then transformed to a scaled score of 0-100 comparable to the original WHOQOL-100 therefore a total score between 0-400 with high scores indicating better quality of life.
The WHOQOLBref has good reliability and validity.
|
post intervention and post hand-held game, each lasts 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (ACTUAL)
November 1, 2010
Study Completion (ACTUAL)
June 1, 2012
Study Registration Dates
First Submitted
November 7, 2012
First Submitted That Met QC Criteria
November 21, 2012
First Posted (ESTIMATE)
November 28, 2012
Study Record Updates
Last Update Posted (ACTUAL)
August 9, 2021
Last Update Submitted That Met QC Criteria
July 15, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Dementia
- Cognition Disorders
- Chorea
- Huntington Disease
Other Study ID Numbers
- 2008H0109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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