Trial Outcomes & Findings for Wii-Fit For Balance And Gait In Elderly Veterans (NCT NCT02190045)

Results Overview

The primary efficacy outcome was the Berg Balance Scale (BBS), which assesses balance impairments in older adults and is a good measure of static and dynamic stability. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from "0" (lowest level of function) to "4" (highest level). The maximum score is 56. BBS has an excellent inter-rater reliability (0.98). A change of four points is considered the minimally detectable change for community dwelling older adults that ambulate without an assistive device.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

8 weeks

Results posted on

2018-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Wii-Fit Program Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks Wii-Fit exercises: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks	Cognitive Remediation Program Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks Cognitive remediation exercises: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks
Overall Study STARTED	15	15
Overall Study COMPLETED	12	15
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wii-Fit For Balance And Gait In Elderly Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wii-Fit Program n=15 Participants Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks Wii-Fit exercises: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks	Cognitive Remediation Program n=15 Participants Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks Cognitive remediation exercises: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks	Total n=30 Participants Total of all reporting groups
Age, Continuous	67.5 years STANDARD_DEVIATION 8.1 • n=99 Participants	69.0 years STANDARD_DEVIATION 3.8 • n=107 Participants	68.0 years STANDARD_DEVIATION 6.7 • n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Sex: Female, Male Male	13 Participants n=99 Participants	13 Participants n=107 Participants	26 Participants n=206 Participants
Race/Ethnicity, Customized Race · Non-Hispanic Caucasian	8 Participants n=99 Participants	12 Participants n=107 Participants	20 Participants n=206 Participants
Race/Ethnicity, Customized Race · Non-Hispanic African American	7 Participants n=99 Participants	3 Participants n=107 Participants	10 Participants n=206 Participants
Berg Balance Scale	48.5 units on a scale STANDARD_DEVIATION 2.6 • n=99 Participants	50.1 units on a scale STANDARD_DEVIATION 2.5 • n=107 Participants	49.3 units on a scale STANDARD_DEVIATION 2.6 • n=206 Participants

PRIMARY outcome

Timeframe: 8 weeks

The primary efficacy outcome was the Berg Balance Scale (BBS), which assesses balance impairments in older adults and is a good measure of static and dynamic stability. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from "0" (lowest level of function) to "4" (highest level). The maximum score is 56. BBS has an excellent inter-rater reliability (0.98). A change of four points is considered the minimally detectable change for community dwelling older adults that ambulate without an assistive device.

Outcome measures

Outcome measures
Measure	Wii-Fit Program n=15 Participants Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks Wii-Fit exercises: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks	Cognitive Remediation Program n=15 Participants Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks Cognitive remediation exercises: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks
Berg Balance Scale	48.5 units on a scale Standard Deviation 2.6	50.1 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

Adverse Events

Wii-Fit Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive Remediation Program

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

Kalpana Padala, MD

CAVHS/ UAMS

Phone: 501-257-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place