Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit

This study has been completed.
Sponsor:
Collaborators:
Regional research committee in the Uppsala/örebro region, Sweden
Norrbacka Eugenia stiftelsen, The Norrbacka-Eugenia charity, Sweden
Information provided by (Responsible Party):
Anette Forsberg, Örebro County Council
ClinicalTrials.gov Identifier:
NCT01299025
First received: February 17, 2011
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Other: Training using Nintendo Wii Fit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit

Resource links provided by NLM:


Further study details as provided by Örebro County Council:

Primary Outcome Measures:
  • Timed Up and Go test [ Time Frame: Measured at day 1 and then at day 42, before and after the training period ] [ Designated as safety issue: No ]
    time in seconds, rising from a chair, walking 3 meters, turn och walk back and sit down


Secondary Outcome Measures:
  • Dynamic Gait Index [ Time Frame: Measured at day 1 and day 42, before and after the training ] [ Designated as safety issue: No ]
    8 items of gait and balance

  • Activities specific balance scale [ Time Frame: Measured at day 1 and day 42, before and after the training period ] [ Designated as safety issue: No ]
    self-rating scale of balance activities

  • 12 item walking scale [ Time Frame: Measured at day 1 and day 42, before and after the training ] [ Designated as safety issue: No ]
    self-rating scale of walking limitations


Enrollment: 84
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Participants allocated as controls receive no treatment. They may be physically active as usual.
Experimental: Training with Nintendo Wii Fit
Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week
Other: Training using Nintendo Wii Fit
Training 2 times per week, 30 minutes, for 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299025

Locations
Sweden
Mälarsjukhuset
Eskilstuna, Sweden, 63188
Karlstad hospital
Karlstad, Sweden
Västerås hospital
Västerås, Sweden, 72189
Family Medicine Research centre
Örebro, Sweden, 70116
Sponsors and Collaborators
Örebro County Council
Regional research committee in the Uppsala/örebro region, Sweden
Norrbacka Eugenia stiftelsen, The Norrbacka-Eugenia charity, Sweden
Investigators
Principal Investigator: Anette Forsberg, PhD Örebro County Council
  More Information

No publications provided

Responsible Party: Anette Forsberg, PhD, Research physical therapist, Örebro County Council
ClinicalTrials.gov Identifier: NCT01299025     History of Changes
Other Study ID Numbers: Ö28-10
Study First Received: February 17, 2011
Last Updated: March 23, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Örebro County Council:
balance
walking

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014