Trial Outcomes & Findings for Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit (NCT NCT01299025)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

Measured at day 1 (before the training period) and at day 42 (after the training period)

Results posted on

2015-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Control Participants allocated as controls receive no treatment. They may be physically active as usual.	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.
Overall Study STARTED	42	42
Overall Study COMPLETED	39	41
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Participants allocated as controls receive no treatment. They may be physically active as usual.	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.
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=42 Participants Participants allocated as controls receive no treatment. They may be physically active as usual.	Training With Nintendo Wii Fit n=42 Participants 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.	Total n=84 Participants Total of all reporting groups
Age, Continuous	49.4 years STANDARD_DEVIATION 11.1 • n=93 Participants	50.0 years STANDARD_DEVIATION 11.5 • n=4 Participants	49.8 years STANDARD_DEVIATION 11.2 • n=27 Participants
Sex: Female, Male Female	32 Participants n=93 Participants	32 Participants n=4 Participants	64 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Region of Enrollment Sweden	42 participants n=93 Participants	42 participants n=4 Participants	84 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=39 Participants Participants allocated as controls receive no treatment. They may be physically active as usual.	Training With Nintendo Wii Fit n=41 Participants 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.
Change in Timed Up and Go Test From Day 1 to Day 42	0.1 seconds Standard Deviation 2.1	-0.8 seconds Standard Deviation 2.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=39 Participants Participants allocated as controls receive no treatment. They may be physically active as usual.	Training With Nintendo Wii Fit n=41 Participants 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.
Change in Score on the Dynamic Gait Index From Day 1 to Day 42	1.0 Scores on a scale Standard Deviation 2.0	1.78 Scores on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=39 Participants Participants allocated as controls receive no treatment. They may be physically active as usual.	Training With Nintendo Wii Fit n=41 Participants 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.
Change in the Activities-specific Balance Confidence (ABC) Scalefrom Day 1 to Day 42	2.7 Scores on a scale Standard Deviation 11.8	5.0 Scores on a scale Standard Deviation 14.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=39 Participants Participants allocated as controls receive no treatment. They may be physically active as usual.	Training With Nintendo Wii Fit n=41 Participants 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.
Change in the 12 Item Walking Scale From Day 1 to Day 42	-3.95 Scores on a scale Standard Deviation 18.1	-5.9 Scores on a scale Standard Deviation 11.5

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Training With Nintendo Wii Fit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Anette Forsberg

Region Örebro County

Phone: +46-19-6025788

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place