- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04110002
An Injury Prevention Program for Professional Ballet
September 27, 2019 updated by: Joshua D Harris, MD, The Methodist Hospital Research Institute
An Injury Prevention Program for Professional Ballet: a Randomized Controlled Investigation
The aim of this study is to evaluate the efficacy of an injury prevention program for professional ballet dancers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Professional Ballet Dancer
- Willing to participate and undergo informed consent process
Exclusion Criteria:
- Pregnant Women, non-English speaking subjects, or those who decline participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Injury Prevention Program
Those allocated to the injury prevention program will be instructed on the program, the added exercises, and the additional time commitment.
|
|
|
No Intervention: Control
The control group will practice and perform with no change to pre-existing years' standard operating practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Injury
Time Frame: 1 year
|
Number of injuries sustained and reported per subject during the 1 year study.
Data will be aggregated according to arm of study to ascertain the rate of injury for each group.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Turn-out degrees
Time Frame: 1 year
|
Turn-out degree values to measure flexibility and strength.
Turnout is the sum of hip rotation, tibial torsion, and contributions from the foot.
|
1 year
|
|
Beighton
Time Frame: 1 year
|
Beighton scale to ascertain generalized joint laxity.
Maximum score of 9, minimum score of 0.
|
1 year
|
|
AOFAS ankle-hindfoot
Time Frame: 1 year
|
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score. 100 point total score.
Instrument combines functional outcome and pain for subject's ankle or hindfoot.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joshua D Harris, MD, The Methodist Hospital Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
September 26, 2019
First Submitted That Met QC Criteria
September 27, 2019
First Posted (Actual)
October 1, 2019
Study Record Updates
Last Update Posted (Actual)
October 1, 2019
Last Update Submitted That Met QC Criteria
September 27, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00014833
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to privacy concerns, no individual participant data will be available.
Only aggregate data may be provided.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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