Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit

CompletedNot a drug-phase studyMS (type not specified)NCT01299025

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Change in Timed Up and Go Test From Day 1 to Day 42 <0.01

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Training using Nintendo Wii Fit

Results by group

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)

GroupValueIntervalNumber analysed
Control0.1 seconds2.1 (Standard Deviation)39
Training With Nintendo Wii Fit-0.8 seconds2.4 (Standard Deviation)41

Control

0.1

Training With Nintendo Wii Fit

-0.8

p = <0.01

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Control420 (0.0%)
Training With Nintendo Wii Fit420 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • 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)

    Walking and mobility

Other measures (3)

  • 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)

    Walking and mobility
  • 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)

    Walking and mobility
  • 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

    Walking and mobility

Who could take part

MS (type not specified) · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Sept 2010

    2. Main results due

      Jun 2011

    3. Finished

      Jun 2011

    4. Results posted

      Apr 2015

    Assembled by software from public sources.