Trial Outcomes & Findings for The Effect of Video Game Exercise on Dynamic Balance and Gait in Individuals With Huntington's Disease (NCT NCT01735981)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

6 weeks

Results posted on

2021-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Dance Dance Revolution Exercise, Then Hand Held Video Game (Control) 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.	Hand Held Video Game (Control), Then Dance Dance Revolution Exercise 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.
Allocated STARTED	13	11
Allocated COMPLETED	11	8
Allocated NOT COMPLETED	2	3
Crossed Over STARTED	11	7
Crossed Over COMPLETED	11	7
Crossed Over NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dance Dance Revolution Exercise, Then Hand Held Video Game (Control) n=13 Participants 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.	Hand Held Video Game (Control), Then Dance Dance Revolution Exercise n=11 Participants 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 n=24 Participants Total of all reporting groups
Age, Continuous	52.9 years STANDARD_DEVIATION 13 • n=5 Participants	50 years STANDARD_DEVIATION 16.4 • n=7 Participants	51.6 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: 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).

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

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=17 Participants 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.	Hand Held Video Game (Control) n=17 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Gait Parameters	1.289 meters per second Standard Deviation 0.47	1.292 meters per second Standard Deviation 0.47

PRIMARY outcome

Timeframe: 6 weeks

Population: 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).

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

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=17 Participants 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.	Hand Held Video Game (Control) n=17 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Gait Parameters	123.35 cm Standard Deviation 35.23	123.11 cm Standard Deviation 35.9

PRIMARY outcome

Timeframe: 6 weeks

Population: 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).

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

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=17 Participants 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.	Hand Held Video Game (Control) n=17 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Gait Parameters	36.82 percentage of gait cycle spent in swing Standard Deviation 3.64	36.01 percentage of gait cycle spent in swing Standard Deviation 4.33

PRIMARY outcome

Timeframe: 6 weeks

Population: 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).

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

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=17 Participants 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.	Hand Held Video Game (Control) n=17 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Gait Parameters	25.83 percent of gait cycle in double support Standard Deviation 7.36	28.34 percent of gait cycle in double support Standard Deviation 8

PRIMARY outcome

Timeframe: 6 weeks

Population: 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).

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

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=17 Participants 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.	Hand Held Video Game (Control) n=17 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Gait Parameters	12.37 cm Standard Deviation 5.14	12.69 cm Standard Deviation 5.41

PRIMARY outcome

Timeframe: 6 weeks

Population: 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).

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

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=16 Participants 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.	Hand Held Video Game (Control) n=16 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Gait Parameters	0.81 meters per second Standard Deviation 0.41	0.83 meters per second Standard Deviation 0.42

PRIMARY outcome

Timeframe: 6 weeks

Population: 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).

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

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=16 Participants 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.	Hand Held Video Game (Control) n=16 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Gait Parameters	81.09 cm Standard Deviation 31.78	83.44 cm Standard Deviation 32.6

PRIMARY outcome

Timeframe: 6 weeks

Population: 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).

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

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=16 Participants 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.	Hand Held Video Game (Control) n=16 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Gait Parameters	37.24 percentage of gait cycle spent in swing Standard Deviation 4.05	35.83 percentage of gait cycle spent in swing Standard Deviation 4.37

PRIMARY outcome

Timeframe: 6 weeks

Population: 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).

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

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=16 Participants 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.	Hand Held Video Game (Control) n=16 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Gait Parameters	26.43 percent of gait cycle in double support Standard Deviation 10.54	30.71 percent of gait cycle in double support Standard Deviation 9.44

PRIMARY outcome

Timeframe: 6 weeks

Population: 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).

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

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=16 Participants 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.	Hand Held Video Game (Control) n=16 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Gait Parameters	20.61 cm Standard Deviation 5.71	21.28 cm Standard Deviation 5.41

PRIMARY outcome

Timeframe: 6 weeks

Population: 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).

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

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=17 Participants 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.	Hand Held Video Game (Control) n=17 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Gait Parameters	1.16 meters per second Standard Deviation 0.49	1.14 meters per second Standard Deviation 0.43

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=18 Participants 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.	Hand Held Video Game (Control) n=18 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Tinetti Mobility Test	22.94 score on a scale Standard Deviation 4.23	22.61 score on a scale Standard Deviation 3.29

SECONDARY outcome

Timeframe: 6 weeks

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

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.

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=17 Participants 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.	Hand Held Video Game (Control) n=17 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Four Square Step Test	10.19 seconds Standard Deviation 3.77	10.02 seconds Standard Deviation 7.81

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=18 Participants 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.	Hand Held Video Game (Control) n=18 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
Activities-Specific Balance Confidence Scale	78.40 score on a scale Standard Deviation 15.64	77.56 score on a scale Standard Deviation 15.24

SECONDARY outcome

Timeframe: post intervention and post hand-held game, each lasts 6 weeks

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

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.

Outcome measures

Outcome measures
Measure	Dance Dance Revolution Exercise n=17 Participants 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.	Hand Held Video Game (Control) n=17 Participants All participants that completed the hand-held video game control group for the first 6 weeks or the second 6 weeks of the study.
World Health Organization Quality of Life	286 score on a scale Standard Deviation 67.96	294 score on a scale Standard Deviation 58.96

Adverse Events

Dance Dance Revolution Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hand Held Video Game (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anne Kloos

The Ohio State University

Phone: 614-688-5942

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place