Wii-Fit For Balance And Gait In Elderly Veterans
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02190045|
Recruitment Status : Completed
First Posted : July 15, 2014
Results First Posted : September 24, 2018
Last Update Posted : September 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gait, Unsteady Postural Balance||Other: Wii-Fit exercises Other: Cognitive remediation exercises||Not Applicable|
Objectives/Rationale Falls are a major public health problem. They are the leading cause of injuries and injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly. Despite the many proven benefits of exercise, many older adults in the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit as an exercise program.
- To establish the safety, feasibility, and efficacy of an 8-week Wii-Fit program to improve measures of balance, and gait in older adults, compared to a cognitive remediation program, Brain fitness.
- To compare the effect of an 8-week Wii-Fit program to Brain fitness program, on measures of biomechanical assessment, adherence, safety, physical activity, fear of fall, enjoyment, functional status, cognition and quality of life.
Design 8-week, randomized, parallel group, active intervention study Methods Patients will be recruited via IRB approved flyers posted in various locations of the Little Rock and North Little Rock CAVHS campuses and via referrals from the CAVHS providers. Thirty elderly Veterans will be randomly assigned to Wii-Fit arm or Brain fitness arm. Both groups will participate in the intervention for approximately 45 minutes 3 days a week for 8 weeks. Outcome measures will be assessed at baseline, and approximately week 4 and after completion of week 8. Balance and gait will be assessed by Berg Balance Scale. Secondary outcome measures include biomechanical testing for gait and balance, Safety, Adherence, measures of functional status, cognition, quality of life, fear of falling, physical activity and physical activity enjoyment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Wii-Fit For Balance And Gait In Elderly Veterans|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||December 2016|
Experimental: Wii-Fit program
Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
Other: Wii-Fit exercises
Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks
Placebo Comparator: Cognitive remediation program
Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
Other: Cognitive remediation exercises
Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks
- Berg Balance Scale [ Time Frame: 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.
- Quality of Life (SF-36) [ Time Frame: 8 weeks ]
- Functional Status Measures [ Time Frame: 8 weeks ]
- Activities Specific Balance Confidence Scale [ Time Frame: 8 weeks ]
- Modified Mini- Mental Exam [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190045
|United States, Arkansas|
|Central Arkansas Veterans Healthcare System (3J/NLR)|
|North Little Rock, Arkansas, United States, 72114|
|Principal Investigator:||Kalpana Padala, MD||Central Arkansas Veterans Healthcare System|