Accidents SportsNCT04110002
An Injury Prevention Program for Professional Ballet
A study testing Injury Prevention Program in people with Accidents Sports and Injury Prevention, run by The Methodist Hospital Research Institute.
Trial summary
The aim of this study is to evaluate the efficacy of an injury prevention program for professional ballet dancers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Accidents Sports, Injury Prevention
- What is being tested?
- Injury Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2016to 1 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Professional Ballet Dancer
- Willing to participate and undergo informed consent process
Who cannot join
- Pregnant Women, non-English speaking subjects, or those who decline participation in the study.
About this study
Official title: 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.
- Conditions
- Accidents Sports, Injury Prevention
- Being tested
- Injury Prevention Program
- Keywords
- injury prevention program; professional ballet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injury Prevention ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Injury Prevention Program |
| Control | No intervention | The control group will practice and perform with no change to pre-existing years' standard operating practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 1 year
Beighton
Beighton scale to ascertain generalized joint laxity. Maximum score of 9, minimum score of 0.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start15 Jul 2016
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidents SportsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arm: randomized to injury prevention protocol or control group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua D Harris, MD, The Methodist Hospital Research Institute
- Investigators
- Joshua D Harris, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110002
- Sponsor's protocol ID
- Pro00014833
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy concerns, no individual participant data will be available. Only aggregate data may be provided.
Publications
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.
PubMed 32782904
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Injury Prevention Program for Professional Ballet: a Randomized Controlled Investigation
- ClinicalTrials.gov ID
- NCT04110002
- Acronym / sponsor ID
- Pro00014833
- Conditions
- Accidents Sports, Injury Prevention
- Keywords
- injury prevention program; professional ballet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the efficacy of an injury prevention program for professional ballet dancers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arm: randomized to injury prevention protocol or control group
| Arm | Type | Receives |
|---|---|---|
| Injury Prevention Program | Experimental | Behavioral: Injury Prevention ProgramThose allocated to the injury prevention program will be instructed on the program, the added exercises, and the additional time commitment. |
| Control | No intervention | –The control group will practice and perform with no change to pre-existing years' standard operating practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Professional Ballet Dancer
- Willing to participate and undergo informed consent process
Key exclusion criteria (1 listed)
- Pregnant Women, non-English speaking subjects, or those who decline participation in the study.
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 |
|---|---|---|
| Injury Prevention Program | Behavioural | Injury Prevention Program |
Primary outcome
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.
3 secondary outcomes
Turn-out degrees
Time frame: 1 year
Beighton
Time frame: 1 year
AOFAS ankle-hindfoot
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Derived from this study: PubMed 32782904Vera 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.
- Individual participant dataSharing planned: No. Due to privacy concerns, no individual participant data will be available. Only aggregate data may be provided.
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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.
Joshua D Harris, MD principal investigator
The Methodist Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Injury Prevention Program in people with Accidents Sports and Injury Prevention, run by The Methodist Hospital Research Institute.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Injury (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04110002, which also lists 1 linked publication.
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 1 Oct 2019.