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

This study has been terminated.
(Difficulty in recruitment of study participants in alloted time and funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01007643
First Posted: November 4, 2009
Last Update Posted: September 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Manitoba
Results First Submitted: July 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions: Patellofemoral Syndrome
Patellofemoral Pain Syndrome
Anterior Knee Pain Syndrome
Interventions: Other: Wii Fit (TM) Interactive Video Game
Other: Traditional Home Exercise Program

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Wii Fit (TM) Interactive Video Game   Traditional Exercise Program
STARTED   8   14 
COMPLETED   8   14 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Wii Fit (TM) Interactive Video Game   Traditional Exercise Program   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   14   22 
Age 
[Units: Participants]
     
<=18 years   8   14   22 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.6  (1.5)   13.5  (1.5)   13.2  (1.5) 
Gender 
[Units: Participants]
     
Female   8   14   22 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Canada   8   14   22 


  Outcome Measures

1.  Primary:   Percentage of Exercise Days Completed.   [ Time Frame: 3 months ]

2.  Secondary:   Changes in Patellofemoral Symptoms   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Change in Hamstring Flexibility   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Change in Quadriceps Flexibility   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Change in Vastus Medialis Oblique Muscle Strength   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Erika Persson
Organization: University of Manitoba
phone: 780-492-4752
e-mail: epersson@ualberta.ca



Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01007643     History of Changes
Other Study ID Numbers: B2009:115
First Submitted: November 3, 2009
First Posted: November 4, 2009
Results First Submitted: July 23, 2012
Results First Posted: September 27, 2012
Last Update Posted: September 27, 2012