Multiple SclerosisNCT01299025
Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit
A study testing Training using Nintendo Wii Fit in people with Multiple Sclerosis, run by Örebro County Council at 4 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Training using Nintendo Wii Fit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 4 sitesSweden
- Study dates
- Sep 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed multiple sclerosis
- Subjective experience of affected balance and walking
- Being able to walk 100 meters with assistance
Who cannot join
- Cognitive or language deficits that prevents using the self-rating scales
- Visual deficits that prevents training with television games
- Weight above 149 kg
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Mälarsjukhuset
Eskilstuna, 63188
Karlstad hospital
Karlstad
Family Medicine Research centre
Örebro, 70116
Västerås hospital
Västerås, 72189
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Training using Nintendo Wii Fit
- Keywords
- balance, walking
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training using Nintendo Wii FitOther
Training 2 times per week, 30 minutes, for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Training using Nintendo Wii Fit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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: 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
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: Measured at day 1 (before training) and day 42 (after training)
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: Measured at day 1 and day 42, before and after the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Collaborators
- Uppsala-Örebro Regional Research Council, Norrbacka-Eugenia Foundation
- Responsible party
- Principal investigator, Anette Forsberg, PhD, Örebro County Council
- Investigators
- Anette Forsberg, PhD, Principal investigator, Örebro County Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299025
- Sponsor's protocol ID
- Ö28-10
- Status last verified
- Apr 2015
- First submitted
- 17 Feb 2011
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit
- ClinicalTrials.gov ID
- NCT01299025
- Acronym / sponsor ID
- Ö28-10
- Conditions
- Multiple Sclerosis
- Keywords
- balance, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Collaborators
- Uppsala-Örebro Regional Research Council, Norrbacka-Eugenia Foundation
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Posted 24 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants allocated as controls receive no treatment. They may be physically active as usual. |
| Training with Nintendo Wii Fit | Experimental | Other: Training using Nintendo Wii FitTraining 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed multiple sclerosis
- Subjective experience of affected balance and walking
- Being able to walk 100 meters with assistance
Key exclusion criteria (3 listed)
- Cognitive or language deficits that prevents using the self-rating scales
- Visual deficits that prevents training with television games
- Weight above 149 kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training using Nintendo Wii FitTraining 2 times per week, 30 minutes, for 6 weeks. | Other | Training with Nintendo Wii Fit |
Primary outcome
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.
3 secondary outcomes
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)
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)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anette Forsberg, PhD principal investigator
Örebro County Council
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training using Nintendo Wii Fit in people with Multiple Sclerosis, run by Örebro County Council at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.