Back to resultsAn Injury Prevention Program for Professional Ballet
Primary Purpose
Accidents Sports, Injury Prevention
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Injury Prevention Program
Sponsored by
About this trial
This is an interventional prevention trial for Accidents Sports focused on measuring injury prevention program; professional ballet
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Injury Prevention Program
Control
Arm Description
Those allocated to the injury prevention program will be instructed on the program, the added exercises, and the additional time commitment.
The control group will practice and perform with no change to pre-existing years' standard operating practice.
Outcomes
Primary Outcome Measures
Rate of Injury
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.
Secondary Outcome Measures
Turn-out degrees
Turn-out degree values to measure flexibility and strength. Turnout is the sum of hip rotation, tibial torsion, and contributions from the foot.
Beighton
Beighton scale to ascertain generalized joint laxity. Maximum score of 9, minimum score of 0.
AOFAS ankle-hindfoot
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.
Full Information
NCT ID
NCT04110002
First Posted
September 26, 2019
Last Updated
September 27, 2019
Sponsor
The Methodist Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04110002
Brief Title
An Injury Prevention Program for Professional Ballet
Official Title
An Injury Prevention Program for Professional Ballet: a Randomized Controlled Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 15, 2016 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Methodist Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the efficacy of an injury prevention program for professional ballet dancers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidents Sports, Injury Prevention
Keywords
injury prevention program; professional ballet
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 arm: randomized to injury prevention protocol or control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injury Prevention Program
Arm Type
Experimental
Arm Description
Those allocated to the injury prevention program will be instructed on the program, the added exercises, and the additional time commitment.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will practice and perform with no change to pre-existing years' standard operating practice.
Intervention Type
Behavioral
Intervention Name(s)
Injury Prevention Program
Primary Outcome Measure Information:
Title
Rate of Injury
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Turn-out degrees
Description
Turn-out degree values to measure flexibility and strength. Turnout is the sum of hip rotation, tibial torsion, and contributions from the foot.
Time Frame
1 year
Title
Beighton
Description
Beighton scale to ascertain generalized joint laxity. Maximum score of 9, minimum score of 0.
Time Frame
1 year
Title
AOFAS ankle-hindfoot
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua D Harris, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Due to privacy concerns, no individual participant data will be available. Only aggregate data may be provided.
Citations:
PubMed Identifier
32782904
Citation
Vera AM, Barrera BD, Peterson LE, Yetter TR, Dong D, Delgado DA, McCulloch PC, Varner KE, Harris JD. An Injury Prevention Program for Professional Ballet: A Randomized Controlled Investigation. Orthop J Sports Med. 2020 Jul 28;8(7):2325967120937643. doi: 10.1177/2325967120937643. eCollection 2020 Jul.
Results Reference
derived
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An Injury Prevention Program for Professional Ballet
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