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

Primary Purpose

Patellofemoral Syndrome, Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Wii Fit (TM) Interactive Video Game
Traditional Home Exercise Program
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Syndrome focused on measuring anterior knee pain, adolescents, female, interactive video games, patellofemoral syndrome, treatment, compliance, home exercises

Eligibility Criteria

11 Years - 17 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female between ages of 11 and 17 years of age
  • A diagnosis of patellofemoral syndrome with one or more of the following symptoms: anterior knee pain, positive theater sign, stairs provoking knee pain.
  • No physiotherapy or regular, structured home exercise program is being followed
  • Parental/guardian consent to participate
  • Patient assent to participate

Exclusion Criteria:

  • Patients participating in physiotherapy at the time of initial assessment or have had physiotherapy in the last 6 months for patellofemoral syndrome
  • Patients performing regular home exercise program prescribed by physician, physiotherapist, or other allied health professional for patellofemoral syndrome at time of initial assessment
  • Patients who have additional knee pathology (e.g. acute patellar dislocation; acute internal knee derangement (i.e. meniscal, ligament injury); osteochondritis dissecans; severe apophysitis or tendinitis) that could interfere with rehabilitation exercises due to pain or instability from these conditions
  • Individuals with history of knee surgery
  • Individuals that have a Wii Fit TM video game at home
  • Individuals for whom consent and assent is not obtained

Sites / Locations

  • Legacy Sport Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wii Fit (TM) Interactive Video Game

Traditional Home Exercise Program

Arm Description

Wii Fit (TM) Interactive Video Game

Traditional Home Exercise Program

Outcomes

Primary Outcome Measures

Percentage of Exercise Days Completed.
Calculated for the 12 week period as daily exercise completion rate as percentage

Secondary Outcome Measures

Changes in Patellofemoral Symptoms
Change in Hamstring Flexibility
Change in Quadriceps Flexibility
Change in Vastus Medialis Oblique Muscle Strength

Full Information

First Posted
November 3, 2009
Last Updated
August 27, 2012
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01007643
Brief Title
Use of Wii Fit (TM) to Increase Compliance With Home Exercises in Treating Patellofemoral Syndrome
Official Title
The Use of Wii Fit ™ to Increase Compliance With Home Exercises for Treatment of Patellofemoral Syndrome in Adolescent Females
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruitment of study participants in alloted time and funding
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Syndrome, Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome
Keywords
anterior knee pain, adolescents, female, interactive video games, patellofemoral syndrome, treatment, compliance, home exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wii Fit (TM) Interactive Video Game
Arm Type
Experimental
Arm Description
Wii Fit (TM) Interactive Video Game
Arm Title
Traditional Home Exercise Program
Arm Type
Active Comparator
Arm Description
Traditional Home Exercise Program
Intervention Type
Other
Intervention Name(s)
Wii Fit (TM) Interactive Video Game
Other Intervention Name(s)
Nintendo Wii Fit (TM)
Intervention Description
Use of interactive video game exercise program on a daily basis focusing on quadriceps and hamstring flexibility along with VMO strengthening.
Intervention Type
Other
Intervention Name(s)
Traditional Home Exercise Program
Intervention Description
Completion of daily home exercise program for quadriceps and hamstring flexibility and VMO strengthening.
Primary Outcome Measure Information:
Title
Percentage of Exercise Days Completed.
Description
Calculated for the 12 week period as daily exercise completion rate as percentage
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in Patellofemoral Symptoms
Time Frame
3 months
Title
Change in Hamstring Flexibility
Time Frame
3 months
Title
Change in Quadriceps Flexibility
Time Frame
3 months
Title
Change in Vastus Medialis Oblique Muscle Strength
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female between ages of 11 and 17 years of age A diagnosis of patellofemoral syndrome with one or more of the following symptoms: anterior knee pain, positive theater sign, stairs provoking knee pain. No physiotherapy or regular, structured home exercise program is being followed Parental/guardian consent to participate Patient assent to participate Exclusion Criteria: Patients participating in physiotherapy at the time of initial assessment or have had physiotherapy in the last 6 months for patellofemoral syndrome Patients performing regular home exercise program prescribed by physician, physiotherapist, or other allied health professional for patellofemoral syndrome at time of initial assessment Patients who have additional knee pathology (e.g. acute patellar dislocation; acute internal knee derangement (i.e. meniscal, ligament injury); osteochondritis dissecans; severe apophysitis or tendinitis) that could interfere with rehabilitation exercises due to pain or instability from these conditions Individuals with history of knee surgery Individuals that have a Wii Fit TM video game at home Individuals for whom consent and assent is not obtained
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika B Persson, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Legacy Sport Medicine
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2M 5L6
Country
Canada

12. IPD Sharing Statement

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

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