NCT04110002

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Status
completed

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

July 15, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 26, 2019

Last Update Submit

September 27, 2019

Conditions

Accidents SportsInjury Prevention

Keywords

injury prevention program; professional ballet

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (3)

  • Turn-out degrees

    1 year

  • Beighton

    1 year

  • AOFAS ankle-hindfoot

    1 year

Study Arms (2)

Injury Prevention Program

EXPERIMENTAL

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

Control

NO INTERVENTION

The control group will practice and perform with no change to pre-existing years' standard operating practice.

Interventions

Injury Prevention ProgramBEHAVIORAL
Injury Prevention Program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Professional Ballet Dancer
  • Willing to participate and undergo informed consent process

You may not qualify if:

  • Pregnant Women, non-English speaking subjects, or those who decline participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32782904DERIVED

Study Officials

  • Joshua D Harris, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 2 arm: randomized to injury prevention protocol or control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2019

First Posted

October 1, 2019

Study Start

July 15, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Due to privacy concerns, no individual participant data will be available. Only aggregate data may be provided.