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Difficulty in recruitment of study participants in alloted time and funding
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To determine the utility of the Wii Fit TM interactive video game program in patellofemoral symptom resolution, development of increased muscle strength and flexibility as a result of increased compliance with home exercises in adolescent females with patellofemoral syndrome.
Patellofemoral syndrome (PFS) is a very common diagnosis amongst adolescents and young adults. Symptoms can be chronic in nature and interfere with sporting activity and activities of daily living. Current treatment consists of home exercises to increase muscular strength and flexibility. Adolescents are known to have poor compliance with treatments for chronic illnesses.
There is a paucity of published literature surrounding the Wii TM Interactive Video Game. There has been one published report of the use of Wii Fit TM in rehabilitation where participants used the Wii Fit TM to train proprioception after ankle injury. Individuals that participated in the Wii Fit TM group found improvement in their balance on objective measures as well as increased enjoyment with their treatment plan. One anecdotal report used the Wii TM video game in physiotherapy treatments of a college athlete and found a dramatic increase in attendance compliance after introduction of the video game.
This randomized controlled study will determine if using the Wii Fit TM for home exercise completion will increase compliance and subsequently improve symptoms related to patellofemoral syndrome in adolescent females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wii Fit (TM) Interactive Video Game | Experimental | Wii Fit (TM) Interactive Video Game |
|
| Traditional Home Exercise Program | Active Comparator | Traditional Home Exercise Program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wii Fit (TM) Interactive Video Game | Other | Use of interactive video game exercise program on a daily basis focusing on quadriceps and hamstring flexibility along with VMO strengthening. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Exercise Days Completed. | Calculated for the 12 week period as daily exercise completion rate as percentage | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Patellofemoral Symptoms | 3 months | |
| Change in Hamstring Flexibility | 3 months | |
| Change in Quadriceps Flexibility |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erika B Persson, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Legacy Sport Medicine | Winnipeg | Manitoba | R2M 5L6 | Canada |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Traditional Home Exercise Program | Other | Completion of daily home exercise program for quadriceps and hamstring flexibility and VMO strengthening. |
|
| 3 months |
| Change in Vastus Medialis Oblique Muscle Strength | 3 months |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Percentage of Exercise Days Completed. | Calculated for the 12 week period as daily exercise completion rate as percentage | Per Protocol | Posted | Mean | Full Range | percentage of days completed | 3 months |
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| Secondary | Changes in Patellofemoral Symptoms | Not Posted | 3 months | ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Hamstring Flexibility | Not Posted | 3 months | ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Quadriceps Flexibility | Not Posted | 3 months | ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Vastus Medialis Oblique Muscle Strength | Not Posted | 3 months |
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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 | 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. | 0 | 8 | 0 | 8 | ||
| EG001 | 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. | 0 | 14 | 0 | 14 |
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Early termination of the study lead to less than the required number of study subjects enrolled. Thus secondary outcome measures could not be calculated with certainty.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Erika Persson | University of Manitoba | 780-492-4752 | epersson@ualberta.ca |
| ID | Term |
|---|---|
| D046788 | Patellofemoral Pain Syndrome |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| >=65 years |
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| Male |
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