Patellofemoral SyndromeNCT01007643
Use of Wii Fit (TM) to Increase Compliance With Home Exercises in Treating Patellofemoral Syndrome
A study testing Wii Fit (TM) Interactive Video Game and Traditional Home Exercise Program in people with Patellofemoral Syndrome and Patellofemoral Pain Syndrome, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 years, women only
- Conditions the study is for
- Patellofemoral Syndrome, Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome
- What is being tested?
- Wii Fit (TM) Interactive Video Game and Traditional Home Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Wii Fit ™ to Increase Compliance With Home Exercises for Treatment of Patellofemoral Syndrome in Adolescent Females
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.
Read the 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.
- Being tested
- Wii Fit (TM) Interactive Video Game, Traditional Home Exercise Program
- Keywords
- anterior knee pain, adolescents, female, interactive video games, patellofemoral syndrome, treatment, compliance, home exercises
- Medical subject headings
- Patellofemoral Pain Syndrome, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii Fit (TM) Interactive Video GameOther
Also called Nintendo Wii Fit (TM)
Use of interactive video game exercise program on a daily basis focusing on quadriceps and hamstring flexibility along with VMO strengthening.
Traditional Home Exercise ProgramOther
Completion of daily home exercise program for quadriceps and hamstring flexibility and VMO strengthening.
| Study group | Role | What they receive |
|---|---|---|
| Wii Fit (TM) Interactive Video Game | Experimental | Wii Fit (TM) Interactive Video Game Receives: Other: Wii Fit (TM) Interactive Video Game |
| Traditional Home Exercise Program | Active comparator | Traditional Home Exercise Program Receives: Other: Traditional Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Exercise Days Completed.
Calculated for the 12 week period as daily exercise completion rate as percentage
Measured: 3 months
Secondary outcomes (4)
Changes in Patellofemoral Symptoms
Measured: 3 months
Change in Hamstring Flexibility
Measured: 3 months
Change in Quadriceps Flexibility
Measured: 3 months
Change in Vastus Medialis Oblique Muscle Strength
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Difficulty in recruitment of study participants in alloted time and funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patellofemoral SyndromeStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erika B Persson, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007643
- Sponsor's protocol ID
- B2009:115
- Status last verified
- Jun 2010
- First submitted
- 3 Nov 2009
- Last updated
- 27 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Wii Fit ™ to Increase Compliance With Home Exercises for Treatment of Patellofemoral Syndrome in Adolescent Females
- ClinicalTrials.gov ID
- NCT01007643
- Acronym / sponsor ID
- B2009:115
- Keywords
- anterior knee pain, adolescents, female, interactive video games, patellofemoral syndrome, treatment, compliance, home exercises
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment of study participants in alloted time and funding
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Posted 27 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wii Fit (TM) Interactive Video Game | Experimental | Other: Wii Fit (TM) Interactive Video GameWii Fit (TM) Interactive Video Game |
| Traditional Home Exercise Program | Active comparator | Other: Traditional Home Exercise ProgramTraditional Home Exercise Program |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wii Fit (TM) Interactive Video GameAlso: Nintendo Wii Fit (TM)Use of interactive video game exercise program on a daily basis focusing on quadriceps and hamstring flexibility along with VMO strengthening. | Other | Wii Fit (TM) Interactive Video Game |
| Traditional Home Exercise ProgramCompletion of daily home exercise program for quadriceps and hamstring flexibility and VMO strengthening. | Other | Traditional Home Exercise Program |
Primary outcome
Percentage of Exercise Days Completed.
Time frame: 3 months
Calculated for the 12 week period as daily exercise completion rate as percentage
4 secondary outcomes
Changes in Patellofemoral Symptoms
Time frame: 3 months
Change in Hamstring Flexibility
Time frame: 3 months
Change in Quadriceps Flexibility
Time frame: 3 months
Change in Vastus Medialis Oblique Muscle Strength
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Patellofemoral Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika B Persson, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wii Fit (TM) Interactive Video Game and Traditional Home Exercise Program in people with Patellofemoral Syndrome and Patellofemoral Pain Syndrome, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Exercise Days Completed. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2012.