Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit

Multiple Sclerosis Clinical Trial

Official title:

Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299025
• Other study ID #: Ö28-10
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: April 7, 2015
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: April 2015
• Source: Örebro County Council
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Training using Nintendo Wii Fit
Training 2 times per week, 30 minutes, for 6 weeks.

Locations

Country	Name	City	State
Sweden	Mälarsjukhuset	Eskilstuna
Sweden	Karlstad hospital	Karlstad
Sweden	Family Medicine Research centre	Örebro
Sweden	Västerås hospital	Västerås

Sponsors (3)

Lead Sponsor	Collaborator
Örebro County Council	Norrbacka-Eugenia Foundation, Uppsala-Örebro Regional Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measured at day 1 (before the training period) and at day 42 (after the training period)	No
Secondary	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.	Measured at day 1 (before training) and day 42 (after training)	No
Secondary	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.	Measured at day 1 (before training) and day 42 (after training)	No
Secondary	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.	Measured at day 1 and day 42, before and after the training	No