Balance; DistortedNCT04306068
Plyometrics in the Ankle Stabilizing Muscles in Improving Balance in Ballerinas
A study testing Plyometric protocol in people with Balance; Distorted, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Balance is essential for successful dance performance. The effort of salsa dancers is given by the levels of stability, produced by the muscular activation of lower limbs. The objective of the study is to assess the effectiveness of an intervention of plyometric exercises in the improvement of balance in salsa dancers… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Balance; Distorted
- What is being tested?
- Plyometric protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 24 Mar 2020to 10 Jun 2020
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Dancers
- Female
- From 18 to 25 years
- With more than a year of dance practice
- And without musculoskeletal injury at the time of starting the study.
Who cannot join
- Subjects who do not attend all training sessions
- Pregnant women or intending to remain in state during the study period
- Have not signed the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Intervention by Plyometrics in the Ankle Stabilizers in the Improvement of the Balance in Salsa Dancers From 18 to 25 Years. A Randomized Clinical Study.
Balance is essential for successful dance performance. The effort of salsa dancers is given by the levels of stability, produced by the muscular activation of lower limbs.
The objective of the study is to assess the effectiveness of an intervention of plyometric exercises in the improvement of balance in salsa dancers from 18 to 25 years.
Read more
Randomized clinical study. 40 dancers will be randomized to the two study groups: experimental (application of plyometric exercise protocol) and control (without intervention). The treatment will last 5 weeks, with 2 weekly sessions of 25 minutes each. The dependent variables will be: equilibrium (measured with star excursion balance). The sample distribution will be calculated using the Kolmogorov-Smirnof test. The changes after each evaluation will be calculated with the t-student test. With an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be obtained with Cohen's formula.
It is expected to see improvement in the stability of the ankle and the level of balance in the dancers.
- Conditions
- Balance; Distorted
- Being tested
- Plyometric protocol
- Keywords
- Balance, Plyometrics, Dance, Stability, Injuries
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plyometric protocolOther
Each session will last 20 minutes, with 2 sessions a week, over a period of 5 weeks. The intervention will last 20 minutes, which consists of a 4-station circuit.
Exercise 1: jump on the rope, with your feet together at a moderate pace. Exercise 2: In standing with hands on the hip and hip flexion (one foot in front). Knee flexion and dorsal ankle flexion, with straight trunk. Alternate legs.
Exercise 3: box jump (jump on the box with both feet at the same time). Exercise 4: depth jumps from box to antoher box (jump on the box with both feet at the same time and when falling, immediately jump to the other box).
1 minute with 30 seconds between sets.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Athletes included in the experimental group will perform a plyometric exercise protocol. Each session will consist of a 4-station circuit with 1 minute rest between each station and 30 seconds between sets Receives: Other: Plyometric protocol |
| Control group | No intervention | Athletes included in the control group will follow their usual warm-up routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline stability after treatment and at month
The Star excursion balance test will be used. Before performing the test, the movements will be explained. The test will be calculated in 3 directions with three tapes 140cm long and with a goniometer the subsequent sections of 135º from the previous section will be calculated, and 45º between the subsequent sections.
Participants will start standing with both feet with the midpoint on the intersection mark in the center of the grid. They will be instructed to keep their hands on their hips, their heads facing forward at all times and keeping their feet flat on the floor trying to reach as far as possible in all three directions. The range will be measured by marking the tape with a pen and then measured with a measurement quote.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start24 Mar 2020
- Primary completion30 May 2020
- Study completion10 Jun 2020
Why it stopped: COVID-19 coronavirus pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance; DistortedStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306068
- Sponsor's protocol ID
- DANCE
- Status last verified
- Sep 2021
- First submitted
- 10 Mar 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Intervention by Plyometrics in the Ankle Stabilizers in the Improvement of the Balance in Salsa Dancers From 18 to 25 Years. A Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT04306068
- Acronym / sponsor ID
- DANCE
- Conditions
- Balance; Distorted
- Keywords
- Balance, Plyometrics, Dance, Stability, Injuries
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 coronavirus pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 12 Mar 2020 (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.
Balance is essential for successful dance performance. The effort of salsa dancers is given by the levels of stability, produced by the muscular activation of lower limbs.
The objective of the study is to assess the effectiveness of an intervention of plyometric exercises in the improvement of balance in salsa dancers from 18 to 25 years.
Randomized clinical study. 40 dancers will be randomized to the two study groups: experimental (application of plyometric exercise protocol) and control (without intervention). The treatment will last 5 weeks, with 2 weekly sessions of 25 minutes each. The dependent variables will be: equilibrium (measured with star excursion balance). The sample distribution will be calculated using the Kolmogorov-Smirnof test. The changes after each evaluation will be calculated with the t-student test. With an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be obtained with Cohen's formula.
It is expected to see improvement in the stability of the ankle and the level of balance in the dancers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Plyometric protocolAthletes included in the experimental group will perform a plyometric exercise protocol. Each session will consist of a 4-station circuit with 1 minute rest between each station and 30 seconds between sets |
| Control group | No intervention | –Athletes included in the control group will follow their usual warm-up routine. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Dancers
- Female
- From 18 to 25 years
- With more than a year of dance practice
- And without musculoskeletal injury at the time of starting the study.
Key exclusion criteria (3 listed)
- Subjects who do not attend all training sessions
- Pregnant women or intending to remain in state during the study period
- Have not signed the informed consent
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 |
|---|---|---|
| Plyometric protocolEach session will last 20 minutes, with 2 sessions a week, over a period of 5 weeks. The intervention will last 20 minutes, which consists of a 4-station circuit. Exercise 1: jump on the rope, with your feet together at a moderate pace. Exercise 2: In standing with hands on the hip and hip flexion (one foot in front). Knee flexion and dorsal ankle flexion, with straight trunk. Alternate legs. Exercise 3: box jump (jump on the box with both feet at the same time). Exercise 4: depth jumps from box to antoher box (jump on the box with both feet at the same time and when falling, immediately jump to the other box). 1 minute with 30 seconds between sets. | Other | Experimental group |
Primary outcome
Change from baseline stability after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
The Star excursion balance test will be used. Before performing the test, the movements will be explained. The test will be calculated in 3 directions with three tapes 140cm long and with a goniometer the subsequent sections of 135º from the previous section will be calculated, and 45º between the subsequent sections. Participants will start standing with both feet with the midpoint on the intersection mark in the center of the grid. They will be instructed to keep their hands on their hips, their heads facing forward at all times and keeping their feet flat on the floor trying to reach as far as possible in all three directions. The range will be measured by marking the tape with a pen and then measured with a measurement quote.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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?
A study testing Plyometric protocol in people with Balance; Distorted, run by Investigación en Hemofilia y Fisioterapia 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 5 Sep 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline stability after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 5 Sep 2021.