NCT01299025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

April 24, 2015

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

February 17, 2011

Results QC Date

March 25, 2015

Last Update Submit

April 7, 2015

Conditions

Multiple Sclerosis

Keywords

balancewalking

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (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)

  • 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)

  • 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

Study Arms (2)

Control

NO INTERVENTION

Participants allocated as controls receive no treatment. They may be physically active as usual.

Training with Nintendo Wii Fit

EXPERIMENTAL

Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week

Other: Training using Nintendo Wii Fit

Interventions

Training using Nintendo Wii FitOTHER

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

Training with Nintendo Wii Fit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed multiple sclerosis
  • Subjective experience of affected balance and walking
  • Being able to walk 100 meters with assistance

You may not qualify if:

  • Cognitive or language deficits that prevents using the self-rating scales
  • Visual deficits that prevents training with television games
  • Weight above 149 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mälarsjukhuset

Eskilstuna, 63188, Sweden

Location

Karlstad hospital

Karlstad, Sweden

Location

Family Medicine Research centre

Örebro, 70116, Sweden

Location

Västerås hospital

Västerås, 72189, Sweden

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Dr Anette Forsberg
Organization
Region Örebro County
anette.forsberg@regionorebrolan.se
+46-19-6025788

Study Officials

  • Anette Forsberg, PhD

    Örebro County Council

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Research physical therapist

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 18, 2011

Study Start

September 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 24, 2015

Results First Posted

April 24, 2015

Record last verified: 2015-04

Locations

SE(4)