The Effect of Video Game Exercise on Dynamic Balance and Gait in Individuals With Huntington's Disease

• Sponsor: Anne Kloos (Other)
• Overall Status: Completed
• CT.gov ID: NCT01735981
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Huntington's Disease	Other: Video game exercise using Dance Dance Revolution; Other: hand-held video game	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants completed one arm of the study and then crossed over into the other arm of the studyParticipants completed one arm of the study and then crossed over into the other arm of the study
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Video Game Biofeedback Modulated Exercise (ViBE)on Dynamic Balance and Gait in Individuals With Huntington's Disease
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Gait Parameters [6 weeks]

   utilized GAITRite to obtain spatiotemporal measures of gait: forward velocity.

2. Gait Parameters [6 weeks]

   utilized GAITRite to obtain spatiotemporal measures of gait: forward stride length.

3. Gait Parameters [6 weeks]

   utilized GAITRite to obtain spatiotemporal measures of gait: forward swing percent.

4. Gait Parameters [6 weeks]

   utilized GAITRite to obtain spatiotemporal measures of gait: forward double support percent.

5. Gait Parameters [6 weeks]

   utilized GAITRite to obtain spatiotemporal measures of gait: forward heel to heel base of support.

6. Gait Parameters [6 weeks]

   utilized GAITRite to obtain spatiotemporal measures of gait: backwards velocity.

7. Gait Parameters [6 weeks]

   utilized GAITRite to obtain spatiotemporal measures of gait: backwards stride length.

8. Gait Parameters [6 weeks]

   utilized GAITRite to obtain spatiotemporal measures of gait: backwards swing percent.

9. Gait Parameters [6 weeks]

   utilized GAITRite to obtain spatiotemporal measures of gait: backwards double support percent.

10. Gait Parameters [6 weeks]

    utilized GAITRite to obtain spatiotemporal measures of gait: backwards heel to heel base of support.

11. Gait Parameters [6 weeks]

    utilized GAITRite to obtain spatiotemporal measures of gait: obstacle velocity.

Secondary Outcome Measures

1. Tinetti Mobility Test [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.

2. Four Square Step Test [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.

3. Activities-Specific Balance Confidence Scale [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.

4. World Health Organization Quality of Life [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adults 18 - 79 with a diagnosis of Huntington's disease

Exclusion Criteria:

• cannot walk 10 feet without assistance, any other neurologic condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Atwell Hall	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Anne Kloos

Investigators

• Principal Investigator: Deb Kegelmeyer, DPT, MS, Ohio State University
• Principal Investigator: Anne Kloos, PT, PhD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anne Kloos, Associate Professor Clinical Health and Rehabilitation Sciences, Ohio State University
• ClinicalTrials.gov Identifier: NCT01735981
• Other Study ID Numbers: 2008H0109
• First Posted: Nov 28, 2012
• Last Update Posted: Aug 9, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Anne Kloos, Associate Professor Clinical Health and Rehabilitation Sciences, Ohio State University: Huntington's Disease; gait; exercise; balance; video game
• Additional relevant MeSH terms: Huntington Disease

Study Results

Participant Flow

Arm/Group Title	Dance Dance Revolution Exercise, Then Hand Held Video Game (Control)	Hand Held Video Game (Control), Then Dance Dance Revolution Exercise
Arm/Group Description	Participants first completed the video game exercise using Dance Dance Revolution: use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance. Then participated in a hand held video game as the control activity.	Individuals first participated in the control group: a hand-held video game. Then completed the video game exercise using Dance Dance Revolution: use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance.
Period Title: Allocated
STARTED	13	11
COMPLETED	11	8
NOT COMPLETED	2	3
Period Title: Allocated
STARTED	11	7
COMPLETED	11	7
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Dance Dance Revolution Exercise, Then Hand Held Video Game (Control)	Hand Held Video Game (Control), Then Dance Dance Revolution Exercise	Total
Arm/Group Description	Participants first completed the video game exercise using Dance Dance Revolution: use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance. Then participated in a hand held video game as the control activity.	Individuals first participated in the control group: a hand-held video game. Then completed the video game exercise using Dance Dance Revolution: use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance.	Total of all reporting groups
Overall Participants	13	11	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.9 (13)	50 (16.4)	51.6 (14.3)
Sex: Female, Male (Count of Participants)
Female	9 69.2%	6 54.5%	15 62.5%
Male	4 30.8%	5 45.5%	9 37.5%

Outcome Measures

1. Primary Outcome

Title	Gait Parameters
Description	utilized GAITRite to obtain spatiotemporal measures of gait: forward velocity.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

GAITRite outcome data was eliminated for one participant who consistently exhibited an abnormal gait during testing sessions on the walkway that did not reflect his usual walking pattern. One participant could not walk backward. Thus, 17 participants were included in the GAITRite analysis (n = 16 for backward condition).

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	17	17
Mean (Standard Deviation) [meters per second]	1.289 (0.47)	1.292 (0.47)

2. Secondary Outcome

Title	Tinetti Mobility Test
Description	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.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	18	18
Mean (Standard Deviation) [score on a scale]	22.94 (4.23)	22.61 (3.29)

3. Secondary Outcome

Title	Four Square Step Test
Description	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.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Loss of one participant in Four-Square Step Test due to incomplete data

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	17	17
Mean (Standard Deviation) [seconds]	10.19 (3.77)	10.02 (7.81)

4. Secondary Outcome

Title	Activities-Specific Balance Confidence Scale
Description	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.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	18	18
Mean (Standard Deviation) [score on a scale]	78.40 (15.64)	77.56 (15.24)

5. Secondary Outcome

Title	World Health Organization Quality of Life
Description	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.
Time Frame	post intervention and post hand-held game, each lasts 6 weeks

Outcome Measure Data

Analysis Population Description

Loss of one participant for the WHOQOL-Bref due to incomplete data

Arm/Group Title	Video Game Exercise	Control
Arm/Group Description	Video game exercise using Dance Dance Revolution Video game exercise using Dance Dance Revolution: use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance	hand-held video game control hand-held video game: hand-held video games
Measure Participants	17	17
Mean (Standard Deviation) [score on a scale]	286 (67.96)	294 (58.96)

6. Primary Outcome

Title	Gait Parameters
Description	utilized GAITRite to obtain spatiotemporal measures of gait: forward stride length.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

GAITRite outcome data was eliminated for one participant who consistently exhibited an abnormal gait during testing sessions on the walkway that did not reflect his usual walking pattern. One participant could not walk backward. Thus, 17 participants were included in the GAITRite analysis (n = 16 for backward condition).

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	17	17
Mean (Standard Deviation) [cm]	123.35 (35.23)	123.11 (35.9)

7. Primary Outcome

Title	Gait Parameters
Description	utilized GAITRite to obtain spatiotemporal measures of gait: forward swing percent.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

GAITRite outcome data was eliminated for one participant who consistently exhibited an abnormal gait during testing sessions on the walkway that did not reflect his usual walking pattern. One participant could not walk backward. Thus, 17 participants were included in the GAITRite analysis (n = 16 for backward condition).

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	17	17
Mean (Standard Deviation) [percentage of gait cycle spent in swing]	36.82 (3.64)	36.01 (4.33)

8. Primary Outcome

Title	Gait Parameters
Description	utilized GAITRite to obtain spatiotemporal measures of gait: forward double support percent.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

GAITRite outcome data was eliminated for one participant who consistently exhibited an abnormal gait during testing sessions on the walkway that did not reflect his usual walking pattern. One participant could not walk backward. Thus, 17 participants were included in the GAITRite analysis (n = 16 for backward condition).

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	17	17
Mean (Standard Deviation) [percent of gait cycle in double support]	25.83 (7.36)	28.34 (8)

9. Primary Outcome

Title	Gait Parameters
Description	utilized GAITRite to obtain spatiotemporal measures of gait: forward heel to heel base of support.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

GAITRite outcome data was eliminated for one participant who consistently exhibited an abnormal gait during testing sessions on the walkway that did not reflect his usual walking pattern. One participant could not walk backward. Thus, 17 participants were included in the GAITRite analysis (n = 16 for backward condition).

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	17	17
Mean (Standard Deviation) [cm]	12.37 (5.14)	12.69 (5.41)

10. Primary Outcome

Title	Gait Parameters
Description	utilized GAITRite to obtain spatiotemporal measures of gait: backwards velocity.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

GAITRite outcome data was eliminated for one participant who consistently exhibited an abnormal gait during testing sessions on the walkway that did not reflect his usual walking pattern. One participant could not walk backward. Thus, 17 participants were included in the GAITRite analysis (n = 16 for backward condition).

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	16	16
Mean (Standard Deviation) [meters per second]	0.81 (0.41)	0.83 (0.42)

11. Primary Outcome

Title	Gait Parameters
Description	utilized GAITRite to obtain spatiotemporal measures of gait: backwards stride length.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

GAITRite outcome data was eliminated for one participant who consistently exhibited an abnormal gait during testing sessions on the walkway that did not reflect his usual walking pattern. One participant could not walk backward. Thus, 17 participants were included in the GAITRite analysis (n = 16 for backward condition).

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	16	16
Mean (Standard Deviation) [cm]	81.09 (31.78)	83.44 (32.6)

12. Primary Outcome

Title	Gait Parameters
Description	utilized GAITRite to obtain spatiotemporal measures of gait: backwards swing percent.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

GAITRite outcome data was eliminated for one participant who consistently exhibited an abnormal gait during testing sessions on the walkway that did not reflect his usual walking pattern. One participant could not walk backward. Thus, 17 participants were included in the GAITRite analysis (n = 16 for backward condition).

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	16	16
Mean (Standard Deviation) [percentage of gait cycle spent in swing]	37.24 (4.05)	35.83 (4.37)

13. Primary Outcome

Title	Gait Parameters
Description	utilized GAITRite to obtain spatiotemporal measures of gait: backwards double support percent.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

GAITRite outcome data was eliminated for one participant who consistently exhibited an abnormal gait during testing sessions on the walkway that did not reflect his usual walking pattern. One participant could not walk backward. Thus, 17 participants were included in the GAITRite analysis (n = 16 for backward condition).

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	16	16
Mean (Standard Deviation) [percent of gait cycle in double support]	26.43 (10.54)	30.71 (9.44)

14. Primary Outcome

Title	Gait Parameters
Description	utilized GAITRite to obtain spatiotemporal measures of gait: backwards heel to heel base of support.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

GAITRite outcome data was eliminated for one participant who consistently exhibited an abnormal gait during testing sessions on the walkway that did not reflect his usual walking pattern. One participant could not walk backward. Thus, 17 participants were included in the GAITRite analysis (n = 16 for backward condition).

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	16	16
Mean (Standard Deviation) [cm]	20.61 (5.71)	21.28 (5.41)

15. Primary Outcome

Title	Gait Parameters
Description	utilized GAITRite to obtain spatiotemporal measures of gait: obstacle velocity.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

GAITRite outcome data was eliminated for one participant who consistently exhibited an abnormal gait during testing sessions on the walkway that did not reflect his usual walking pattern. One participant could not walk backward. Thus, 17 participants were included in the GAITRite analysis (n = 16 for backward condition).

Arm/Group Title	Dance Dance Revolution Exercise	Hand Held Video Game (Control)
Arm/Group Description	All participants who completed the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.	All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Measure Participants	17	17
Mean (Standard Deviation) [meters per second]	1.16 (0.49)	1.14 (0.43)

Adverse Events

Time Frame	Course of the time from when the participant was enrolled in the study (8-12 weeks)
Arm/Group Title	Dance Dance Revolution Exercise		Hand Held Video Game (Control)
Arm/Group Description	All participants who were initially enrolled into the group with the video game exercise using Dance Dance Revolution either in the first 6 weeks of the study or the second 6 weeks.		All participants that who were initially enrolled into the control group with the hand-held video game control for the first 6 weeks or the second 6 weeks of the study.
All Cause Mortality
	Dance Dance Revolution Exercise		Hand Held Video Game (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/18 (0%)
Serious Adverse Events
	Dance Dance Revolution Exercise		Hand Held Video Game (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Dance Dance Revolution Exercise		Hand Held Video Game (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.