Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Kalpana Padala, MD, Central Arkansas Veterans Healthcare System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gait, Unsteady
Postural Balance
Interventions Other: Wii-Fit exercises
Other: Cognitive remediation exercises
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Wii-Fit Program Cognitive Remediation Program
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 15 15
Completed 12 15
Not Completed 3 0
Arm/Group Title Wii-Fit Program Cognitive Remediation Program Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
67.5  (8.1) 69.0  (3.8) 68.0  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
2
  13.3%
2
  13.3%
4
  13.3%
Male
13
  86.7%
13
  86.7%
26
  86.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 15 participants 15 participants 30 participants
Non-Hispanic Caucasian
8
  53.3%
12
  80.0%
20
  66.7%
Non-Hispanic African American
7
  46.7%
3
  20.0%
10
  33.3%
Berg Balance Scale  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 30 participants
48.5  (2.6) 50.1  (2.5) 49.3  (2.6)
1.Primary Outcome
Title Berg Balance Scale
Hide Description 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wii-Fit Program Cognitive Remediation Program
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
48.5  (2.6) 50.1  (2.5)
2.Secondary Outcome
Title Quality of Life (SF-36)
Hide Description [Not Specified]
Time Frame 8 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Functional Status Measures
Hide Description [Not Specified]
Time Frame 8 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Activities Specific Balance Confidence Scale
Hide Description [Not Specified]
Time Frame 8 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Modified Mini- Mental Exam
Hide Description [Not Specified]
Time Frame 8 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Wii-Fit Program Cognitive Remediation Program
Hide Arm/Group Description

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 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

All-Cause Mortality
Wii-Fit Program Cognitive Remediation Program
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Wii-Fit Program Cognitive Remediation Program
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Wii-Fit Program Cognitive Remediation Program
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kalpana Padala, MD
Organization: CAVHS/ UAMS
Phone: 501-257-1000
EMail: kppadala@uams.edu
Layout table for additonal information
Responsible Party: Kalpana Padala, MD, Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT02190045     History of Changes
Other Study ID Numbers: 404039
First Submitted: July 11, 2014
First Posted: July 15, 2014
Results First Submitted: January 23, 2018
Results First Posted: September 24, 2018
Last Update Posted: September 24, 2018