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An Injury Prevention Program for Professional Ballet

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.
 
ClinicalTrials.gov Identifier: NCT04110002
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua D Harris, MD, The Methodist Hospital System

Brief Summary:
The aim of this study is to evaluate the efficacy of an injury prevention program for professional ballet dancers.

Condition or disease Intervention/treatment Phase
Accidents Sports Injury Prevention Behavioral: Injury Prevention Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 arm: randomized to injury prevention protocol or control group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Injury Prevention Program for Professional Ballet: a Randomized Controlled Investigation
Actual Study Start Date : July 15, 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 1, 2017

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.
Behavioral: Injury Prevention Program
No Intervention: Control
The control group will practice and perform with no change to pre-existing years' standard operating practice.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Beighton [ Time Frame: 1 year ]
    Beighton scale to ascertain generalized joint laxity. Maximum score of 9, minimum score of 0.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110002


Sponsors and Collaborators
The Methodist Hospital System
Investigators
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Principal Investigator: Joshua D Harris, MD The Methodist Hospital System
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joshua D Harris, MD, Principal Investigator, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT04110002    
Other Study ID Numbers: Pro00014833
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to privacy concerns, no individual participant data will be available. Only aggregate data may be provided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joshua D Harris, MD, The Methodist Hospital System:
injury prevention program; professional ballet
Additional relevant MeSH terms:
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Wounds and Injuries