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| Name | Class |
|---|---|
| Uppsala-Örebro Regional Research Council | OTHER |
| Norrbacka-Eugenia Foundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training using Nintendo Wii Fit | Other | Training 2 times per week, 30 minutes, for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at day 1 (before training) and day 42 (after training) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anette Forsberg, PhD | Örebro County Council | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mälarsjukhuset | Eskilstuna | 63188 | Sweden | |||
| Karlstad hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants allocated as controls receive no treatment. They may be physically active as usual. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants allocated as controls receive no treatment. They may be physically active as usual. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | seconds | Measured at day 1 (before the training period) and at day 42 (after the training period) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants allocated as controls receive no treatment. They may be physically active as usual. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Anette Forsberg | Region Örebro County | +46-19-6025788 | anette.forsberg@regionorebrolan.se |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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 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 at day 1 and day 42, before and after the training |
| Karlstad |
| Sweden |
| Family Medicine Research centre | Örebro | 70116 | Sweden |
| Västerås hospital | Västerås | 72189 | Sweden |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Posted | Mean | Standard Deviation | Scores on a scale | Measured at day 1 (before training) and day 42 (after training) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | Measured at day 1 (before training) and day 42 (after training) |
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|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | Measured at day 1 and day 42, before and after the training |
|
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|
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 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. | 0 | 42 | 0 | 42 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |