NCT01007643

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

September 27, 2012

Completed
Last Updated

September 27, 2012

Status Verified

June 1, 2010

Enrollment Period

11 months

First QC Date

November 3, 2009

Results QC Date

July 23, 2012

Last Update Submit

August 27, 2012

Conditions

Keywords

anterior knee painadolescentsfemaleinteractive video gamespatellofemoral syndrometreatmentcompliancehome exercises

Outcome Measures

Primary Outcomes (1)

  • Percentage of Exercise Days Completed.

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

    3 months

Secondary Outcomes (4)

  • Changes in Patellofemoral Symptoms

    3 months

  • Change in Hamstring Flexibility

    3 months

  • Change in Quadriceps Flexibility

    3 months

  • Change in Vastus Medialis Oblique Muscle Strength

    3 months

Study Arms (2)

Wii Fit (TM) Interactive Video Game

EXPERIMENTAL

Wii Fit (TM) Interactive Video Game

Other: Wii Fit (TM) Interactive Video Game

Traditional Home Exercise Program

ACTIVE COMPARATOR

Traditional Home Exercise Program

Other: Traditional Home Exercise Program

Interventions

Use of interactive video game exercise program on a daily basis focusing on quadriceps and hamstring flexibility along with VMO strengthening.

Also known as: Nintendo Wii Fit (TM)
Wii Fit (TM) Interactive Video Game

Completion of daily home exercise program for quadriceps and hamstring flexibility and VMO strengthening.

Traditional Home Exercise Program

Eligibility Criteria

Age11 Years - 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Legacy Sport Medicine

Winnipeg, Manitoba, R2M 5L6, Canada

Location

MeSH Terms

Conditions

Patellofemoral Pain SyndromePatient Compliance

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Limitations and Caveats

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.

Results Point of Contact

Title
Dr Erika Persson
Organization
University of Manitoba

Study Officials

  • Erika B Persson, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 4, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 27, 2012

Results First Posted

September 27, 2012

Record last verified: 2010-06

Locations