Multiple Sclerosis
Conditions
Keywords
balance, walking
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.
Interventions
OTHERTraining using Nintendo Wii Fit
Training 2 times per week, 30 minutes, for 6 weeks.
Sponsors
Uppsala-Örebro Regional Research Council
Norrbacka-Eugenia Foundation
Örebro County Council
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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. |
| 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 | 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Participants allocated as controls receive no treatment. They may be physically active as usual. | 42 |
| Training With Nintendo Wii Fit Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week
Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks. | 42 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Control | Training With Nintendo Wii Fit | Total |
|---|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 11.1 | 50.0 years STANDARD_DEVIATION 11.5 | 49.8 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment Sweden | 42 participants | 42 participants | 84 participants |
| Sex: Female, Male Female | 32 Participants | 32 Participants | 64 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
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.
Time frame: Measured at day 1 (before the training period) and at day 42 (after the training period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Timed Up and Go Test From Day 1 to Day 42 | 0.1 seconds | Standard Deviation 2.1 |
| Training With Nintendo Wii Fit | Change in Timed Up and Go Test From Day 1 to Day 42 | -0.8 seconds | Standard Deviation 2.4 |
p-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Measured at day 1 (before training) and day 42 (after training)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Score on the Dynamic Gait Index From Day 1 to Day 42 | 1.0 Scores on a scale | Standard Deviation 2 |
| Training With Nintendo Wii Fit | Change in Score on the Dynamic Gait Index From Day 1 to Day 42 | 1.78 Scores on a scale | Standard Deviation 2.3 |
Secondary
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.
Time frame: Measured at day 1 and day 42, before and after the training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in the 12 Item Walking Scale From Day 1 to Day 42 | -3.95 Scores on a scale | Standard Deviation 18.1 |
| Training With Nintendo Wii Fit | Change in the 12 Item Walking Scale From Day 1 to Day 42 | -5.9 Scores on a scale | Standard Deviation 11.5 |
Secondary
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.
Time frame: Measured at day 1 (before training) and day 42 (after training)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in the Activities-specific Balance Confidence (ABC) Scalefrom Day 1 to Day 42 | 2.7 Scores on a scale | Standard Deviation 11.8 |
| Training With Nintendo Wii Fit | Change in the Activities-specific Balance Confidence (ABC) Scalefrom Day 1 to Day 42 | 5.0 Scores on a scale | Standard Deviation 14.4 |