Ankle DiseaseNCT04145206
Ankle Instability in Flamenco Dancers
An observational study of Ankle Disease and Dance, run by University of Seville at 1 site in Spain.
Trial summary
The injuries in the dancers are usually associated with different factors such as the characteristics of the footwear, height of the heel and physical requirements, the articulation of the ankle being the most susceptible when the loads are not adequately dealt. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Disease, Dance
- What is being tested?
- Flamenco dance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 15 Jun 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study has involved a population of 26 healthy subjects divided into two groups of 13 each one
Who may be able to join
- Flamenco dancers
- -
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
The injuries in the dancers are usually associated with different factors such as the characteristics of the footwear, height of the heel and physical requirements, the articulation of the ankle being the most susceptible when the loads are not adequately dealt. The main objective is to evaluate in a sample of subjects if there is a difference in the stability of the ankle, as a consequence of previous sprains, between flamenco dancers and dancers and a dance-free control group.
Read the detailed description
An observational study. This study has involved a population of 26 subjects divided into two groups of 13 each is studied (40,15 ± 4,675 años); the experimental group is characterized by the practice of flamenco dance
- Conditions
- Ankle Disease, Dance
- Being tested
- Flamenco dance
- Keywords
- ankle, dance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flamenco danceBehavioural
evaluation of ankle injuries in the flamenco dancers
| Study group | Role | What they receive |
|---|---|---|
| experimental group | the experimental group is characterized by the practice of flamenco dance Receives: Behavioral: Flamenco dance | |
| control group | not practice of flamenco dance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle drawer test
Evaluation of the ankle drawer test, in millimeters
Measured: A day, the inclusion day in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Mar 2018
- Primary completion1 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurora Castro Mendez, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145206
- Sponsor's protocol ID
- 170111
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Instability in Flamenco Dancers
- ClinicalTrials.gov ID
- NCT04145206
- Acronym / sponsor ID
- 170111
- Conditions
- Ankle Disease, Dance
- Keywords
- ankle, dance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 30 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 injuries in the dancers are usually associated with different factors such as the characteristics of the footwear, height of the heel and physical requirements, the articulation of the ankle being the most susceptible when the loads are not adequately dealt. The main objective is to evaluate in a sample of subjects if there is a difference in the stability of the ankle, as a consequence of previous sprains, between flamenco dancers and dancers and a dance-free control group.
Detailed description
An observational study. This study has involved a population of 26 subjects divided into two groups of 13 each is studied (40,15 ± 4,675 años); the experimental group is characterized by the practice of flamenco dance
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Behavioral: Flamenco dancethe experimental group is characterized by the practice of flamenco dance |
| control group | – | –not practice of flamenco dance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study has involved a population of 26 healthy subjects divided into two groups of 13 each one
Key inclusion criteria (2 listed)
- Flamenco dancers
- -
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| Flamenco danceevaluation of ankle injuries in the flamenco dancers | Behavioural | experimental group |
Primary outcome
Ankle drawer test
Time frame: A day, the inclusion day in the study
Evaluation of the ankle drawer test, in millimeters
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 4 Nov 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Disease and Dance, run by University of Seville at 1 site in Spain.
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 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Ankle drawer test (time frame: A day, the inclusion day in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2019.