Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit
April 7, 2015 updated by: Anette Forsberg, PhD, Örebro County Council
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Eskilstuna, Sweden, 63188
- Mälarsjukhuset
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Karlstad, Sweden
- Karlstad Hospital
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Västerås, Sweden, 72189
- Västerås Hospital
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Örebro, Sweden, 70116
- Family Medicine Research centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
Participants allocated as controls receive no treatment.
They may be physically active as usual.
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Experimental: Training with Nintendo Wii Fit
Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week
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Training 2 times per week, 30 minutes, for 6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Timed Up and Go Test From Day 1 to Day 42
Time Frame: Measured at day 1 (before the training period) and at day 42 (after the training period)
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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.
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Measured at day 1 (before the training period) and at day 42 (after the training period)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Score on the Dynamic Gait Index From Day 1 to Day 42
Time Frame: Measured at day 1 (before training) and day 42 (after training)
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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.
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Measured at day 1 (before training) and day 42 (after training)
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Change in the Activities-specific Balance Confidence (ABC) Scalefrom Day 1 to Day 42
Time Frame: Measured at day 1 (before training) and day 42 (after training)
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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.
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Measured at day 1 (before training) and day 42 (after training)
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Change in the 12 Item Walking Scale From Day 1 to Day 42
Time Frame: Measured at day 1 and day 42, before and after the training
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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.
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Measured at day 1 and day 42, before and after the training
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anette Forsberg, PhD, Örebro County Council
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
February 17, 2011
First Submitted That Met QC Criteria
February 17, 2011
First Posted (Estimate)
February 18, 2011
Study Record Updates
Last Update Posted (Estimate)
April 24, 2015
Last Update Submitted That Met QC Criteria
April 7, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ö28-10
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