Trial Outcomes & Findings for Use of Wii Fit (TM) to Increase Compliance With Home Exercises in Treating Patellofemoral Syndrome (NCT NCT01007643)

NCT ID: NCT01007643

Last Updated: 2012-09-27

Results Overview

Calculated for the 12 week period as daily exercise completion rate as percentage

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2012-09-27

Participant Flow

22 females between 11-17 yrs. of age with untreated patellofemoral syndrome recruited from a pediatric sport medicine clinic from October 2009 to June 2010.

Participant milestones

Measure	Wii Fit (TM) Interactive Video Game Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.	Traditional Exercise Program Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
Overall Study STARTED	8	14
Overall Study COMPLETED	8	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Wii Fit (TM) to Increase Compliance With Home Exercises in Treating Patellofemoral Syndrome

Baseline characteristics by cohort

Measure	Wii Fit (TM) Interactive Video Game n=8 Participants Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.	Traditional Exercise Program n=14 Participants Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	12.6 years STANDARD_DEVIATION 1.5 • n=5 Participants	13.5 years STANDARD_DEVIATION 1.5 • n=7 Participants	13.2 years STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	8 participants n=5 Participants	14 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Per Protocol

Calculated for the 12 week period as daily exercise completion rate as percentage

Outcome measures

Measure	Wii Fit (TM) Interactive Video Game n=8 Participants Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.	Traditional Exercise Program n=14 Participants Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
Percentage of Exercise Days Completed.	48.3 percentage of days completed Interval 15.7 to 72.6	62.4 percentage of days completed Interval 20.2 to 91.6

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

Adverse Events

Wii Fit (TM) Interactive Video Game

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Exercise Program

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 Erika Persson

University of Manitoba

Phone: 780-492-4752

Email: epersson@ualberta.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place