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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: video game exercise
Video game exercise using Dance Dance Revolution
Other: 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:
  • exercise
  • video-game based exercise
Other: hand-held video game
hand-held video games
OTHER: control
hand-held video game control
Other: 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:
  • exercise
  • video-game based exercise
Other: hand-held video game
hand-held video games

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anne Kloos

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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