Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
Study NCT ID:
NCT04306068
Status:
WITHDRAWN
Last Update Posted:
2021-09-05
First Post:
2020-03-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Plyometrics in the Ankle Stabilizing Muscles in Improving Balance in Ballerinas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'COVID-19 coronavirus pandemic', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2020-03-10', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline stability after treatment and at month', 'timeFrame': 'Screening visit, within the first seven days after treatment and after one month follow-up visit', 'description': '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.\n\nParticipants 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balance', 'Plyometrics', 'Dance', 'Stability', 'Injuries'], 'conditions': ['Balance; Distorted']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nRandomized 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.\n\nIt is expected to see improvement in the stability of the ankle and the level of balance in the dancers."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dancers\n* Female\n* From 18 to 25 years\n* With more than a year of dance practice\n* And without musculoskeletal injury at the time of starting the study.\n\nExclusion Criteria:\n\n* Subjects who do not attend all training sessions\n* Pregnant women or intending to remain in state during the study period\n* Have not signed the informed consent'}, 'identificationModule': {'nctId': 'NCT04306068', 'briefTitle': 'Plyometrics in the Ankle Stabilizing Muscles in Improving Balance in Ballerinas', 'organization': {'class': 'NETWORK', 'fullName': 'Investigación en Hemofilia y Fisioterapia'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'DANCE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': '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', 'interventionNames': ['Other: Plyometric protocol']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Athletes included in the control group will follow their usual warm-up routine.'}], 'interventions': [{'name': 'Plyometric protocol', 'type': 'OTHER', 'description': '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.\n\nExercise 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.\n\nExercise 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).\n\n1 minute with 30 seconds between sets.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28670', 'city': 'Madrid', 'state': 'Comunity of Madrid', 'country': 'Spain', 'facility': 'Universidad Europea de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Investigación en Hemofilia y Fisioterapia', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}