Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-29 @ 9:29 AM
Study NCT ID:
NCT04784195
Status:
UNKNOWN
Last Update Posted:
2021-03-11
First Post:
2021-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional and Morphological Characteristics of Neck Muscles in Acrobatic Skydivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535425', 'term': 'Congenital torticollis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anticipatory postural adjustment', 'timeFrame': '10 minutes', 'description': 'Electromyographic test in ms.The myoelectric signal will be recorded by using mDurance R system (mDurance Solutions SL, Granada). The electrodes used will be pre-gelled Ag/AgCl with a diameter of 10mm and an interelectrode distance of 20mm.'}, {'measure': 'Isometric cervical strength', 'timeFrame': '10 minutes', 'description': 'Measured in newton with heandheld Dynamometer (model 001165, Lafayette Instrument Company)'}, {'measure': 'Neck flexor and extensor endurance', 'timeFrame': '10 minutes', 'description': 'Measures in seconds with a stopwatch'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Muscle Issue', 'Sternocleidomastoid; Contracture', 'Deltoid Muscle Strain']}, 'descriptionModule': {'briefSummary': 'An observational cohort study, following the Strengthening the Reporting of Observational Studies in Epidemiology(STROBE) guidelines.\n\nTwo groups will be examined, a group composed by spanish acrobatic skydivers and a control group composed by general physically active population(GPAP).', 'detailedDescription': 'Two groups will be examined for veryfing the morfology and the function of neck muscles.\n\nThe profesional group composed by spanish acrobatic skydivers and a general group composed by general physically active population(GPAP). Both groups are matched at known confounder outcomes such as: physical activity level, age, sex, body weight and history of neck pain. Frequency matching will be carried out, subjects will be matched on known confounders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a high level of physical activity and actualy involved in skydiving practices.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* pain-free in the neck area in the last three months\n* didn't actually take any drugs that can interfere with muscle strength\n\nExclusion Criteria:\n\n* participants that not mached with the skydivers caracteristics"}, 'identificationModule': {'nctId': 'NCT04784195', 'briefTitle': 'Functional and Morphological Characteristics of Neck Muscles in Acrobatic Skydivers', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Murcia'}, 'officialTitle': 'Functional and Morphological Characteristics of Neck Muscles in Acrobatic Skydivers: an Observational Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'CE102001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Profesional acrobatics', 'description': 'Profesional Acrobatic Skyedivers as the cort group', 'interventionNames': ['Behavioral: Observation']}, {'label': 'General active participations', 'description': 'Adults with meched caracteristics with the profesional acrobatics'}], 'interventions': [{'name': 'Observation', 'type': 'BEHAVIORAL', 'description': 'Verification of morfology and functionality of neck muscles', 'armGroupLabels': ['Profesional acrobatics']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Javier Reina Abellan', 'investigatorAffiliation': 'Universidad de Murcia'}}}}