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OpenTrials
Completed

NCT Number: NCT01299025

Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mälarsjukhuset, Eskilstuna, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training using Nintendo Wii Fit

Other

Training 2 times per week, 30 minutes, for 6 weeks.

Primary outcomes

  1. 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)

    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 outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

Örebro County Council

Other Gov

Collaborators

  • Norrbacka-Eugenia Foundation
  • Uppsala-Örebro Regional Research Council

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 18, 2011
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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