Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Training using Nintendo Wii Fit

• Registration Number: NCT01299025
• Lead Sponsor: Örebro County Council

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2015-03-25
• Status Verified: 2015-04
• Results First Submitted QC: 2015-04-07
• Last Update Submitted: 2015-04-07
• Results First Posted: 2015-04-24
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training with Nintendo Wii Fit	Training using Nintendo Wii Fit	Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week

Primary Outcome Measures

Name	Time	Method
Change in Timed Up and Go Test From Day 1 to Day 42	Measured at day 1 (before the training period) and at day 42 (after the training period)	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

Name	Time	Method
Change in the 12 Item Walking Scale From Day 1 to Day 42	Measured at day 1 and day 42, before and after the training	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.
Change in Score on the Dynamic Gait Index From Day 1 to Day 42	Measured at day 1 (before training) and day 42 (after training)	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	Measured at day 1 (before training) and day 42 (after training)	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.

Trial Locations

Locations (4)

Karlstad hospital; 🇸🇪 Karlstad, Sweden

Mälarsjukhuset; 🇸🇪 Eskilstuna, Sweden

Västerås hospital; 🇸🇪 Västerås, Sweden

Family Medicine Research centre; 🇸🇪 Örebro, Sweden