Back to resultsBalance Training for People With Multiple Sclerosis Using Nintendo Wii Fit
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Training using Nintendo Wii Fit
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring balance, walking
Eligibility Criteria
Inclusion Criteria:
- Diagnosed multiple sclerosis
- Subjective experience of affected balance and walking
- Being able to walk 100 meters with assistance
Exclusion Criteria:
- Cognitive or language deficits that prevents using the self-rating scales
- Visual deficits that prevents training with television games
- Weight above 149 kg
Sites / Locations
- Mälarsjukhuset
- Karlstad hospital
- Västerås hospital
- Family Medicine Research centre
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Training with Nintendo Wii Fit
Arm Description
Participants allocated as controls receive no treatment. They may be physically active as usual.
Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week
Outcomes
Primary Outcome Measures
Change in Timed Up and Go Test From Day 1 to Day 42
Change in seconds on the Timed Up and Go test (TUG). In the TUG test time is taken from rising from a chair, walking 3 meters, turning,walking back and sitting down.
Secondary Outcome Measures
Change in Score on the Dynamic Gait Index From Day 1 to Day 42
The Dynamic Gait index consists of 8 items. Performance on each item is rated from 0 (severe impairment) to 3 (nomal performance). Minimum total score is 0 and maximum 24. Higher scores indicate better walking and balance performance.
Change in the Activities-specific Balance Confidence (ABC) Scalefrom Day 1 to Day 42
The ABC scale is a self-rating scale of balance activities in everyday Life. It includes 16 items. The patient rates his/her performance from 0-100. Score on each item are summed an divided by 16. Minimum score is 0 and maximum score 100. A higher score indicate higher confidence in ones balance and walking capacity.
Change in the 12 Item Walking Scale From Day 1 to Day 42
The 12 item walking scale is a self-rating scale of walking limitations. The scale includes 12 items that each are scores from 1 to 5, where 5 is extremely limited. Scores are added and transformed to a scale from 0-100. 0 indicates no limitation and 100 extremely limited.
Full Information
NCT ID
NCT01299025
First Posted
February 17, 2011
Last Updated
April 7, 2015
Sponsor
Örebro County Council
Collaborators
Uppsala-Örebro Regional Research Council, Norrbacka-Eugenia Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01299025
Brief Title
Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit
Official Title
Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro County Council
Collaborators
Uppsala-Örebro Regional Research Council, Norrbacka-Eugenia Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim is to evaluate balance training using Nintendo Wii Fit. The hypothesis is that a period of training will increase balance capacity och self-efficacy.
People with diagnosed multiple sclerosis are invited to participate. Estimation of study power gave that 29 people in each group was necessary to detect a difference in the primary outcome measure, Timed Up and Go test.
Other measures used are the Four square step test, Dynamic Gait Index, Timed stands test, 25 foot walking test, 12-item Walking scale and the ABC scale.
Participants were randomised to either training or control. The training consisted of 6 weeks training with Nintendo Wii Fit 30 minutes 2 times a week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
balance, walking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants allocated as controls receive no treatment. They may be physically active as usual.
Arm Title
Training with Nintendo Wii Fit
Arm Type
Experimental
Arm Description
Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week
Intervention Type
Other
Intervention Name(s)
Training using Nintendo Wii Fit
Intervention Description
Training 2 times per week, 30 minutes, for 6 weeks.
Primary Outcome Measure Information:
Title
Change in Timed Up and Go Test From Day 1 to Day 42
Description
Change in seconds on the Timed Up and Go test (TUG). In the TUG test time is taken from rising from a chair, walking 3 meters, turning,walking back and sitting down.
Time Frame
Measured at day 1 (before the training period) and at day 42 (after the training period)
Secondary Outcome Measure Information:
Title
Change in Score on the Dynamic Gait Index From Day 1 to Day 42
Description
The Dynamic Gait index consists of 8 items. Performance on each item is rated from 0 (severe impairment) to 3 (nomal performance). Minimum total score is 0 and maximum 24. Higher scores indicate better walking and balance performance.
Time Frame
Measured at day 1 (before training) and day 42 (after training)
Title
Change in the Activities-specific Balance Confidence (ABC) Scalefrom Day 1 to Day 42
Description
The ABC scale is a self-rating scale of balance activities in everyday Life. It includes 16 items. The patient rates his/her performance from 0-100. Score on each item are summed an divided by 16. Minimum score is 0 and maximum score 100. A higher score indicate higher confidence in ones balance and walking capacity.
Time Frame
Measured at day 1 (before training) and day 42 (after training)
Title
Change in the 12 Item Walking Scale From Day 1 to Day 42
Description
The 12 item walking scale is a self-rating scale of walking limitations. The scale includes 12 items that each are scores from 1 to 5, where 5 is extremely limited. Scores are added and transformed to a scale from 0-100. 0 indicates no limitation and 100 extremely limited.
Time Frame
Measured at day 1 and day 42, before and after the training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed multiple sclerosis
Subjective experience of affected balance and walking
Being able to walk 100 meters with assistance
Exclusion Criteria:
Cognitive or language deficits that prevents using the self-rating scales
Visual deficits that prevents training with television games
Weight above 149 kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anette Forsberg, PhD
Organizational Affiliation
Örebro County Council
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mälarsjukhuset
City
Eskilstuna
ZIP/Postal Code
63188
Country
Sweden
Facility Name
Karlstad hospital
City
Karlstad
Country
Sweden
Facility Name
Västerås hospital
City
Västerås
ZIP/Postal Code
72189
Country
Sweden
Facility Name
Family Medicine Research centre
City
Örebro
ZIP/Postal Code
70116
Country
Sweden
12. IPD Sharing Statement
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Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit
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