Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-28 @ 10:25 AM
Study NCT ID:
NCT05719532
Status:
UNKNOWN
Last Update Posted:
2023-03-30
First Post:
2023-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Core Strength and Coordinative Skills
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-01-31', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Center of pressure track (COPT)', 'timeFrame': 'Baseline', 'description': 'Posturographic parameter; lower values indicate better postural stability'}, {'measure': 'Area of sway (AOS)', 'timeFrame': 'Baseline', 'description': 'Posturographic parameter; lower values indicate better postural stability'}, {'measure': 'Core stability test of the Swiss Olympic Medical Center', 'timeFrame': 'Baseline', 'description': 'Measurement of Core strength/Core stability in sec; higher values indicate better core strength'}], 'secondaryOutcomes': [{'measure': 'Baecke Questionnaire of Habitual Physical Activity (BQHPA)', 'timeFrame': 'Baseline', 'description': 'Questionnaire of physical fitness; higher values indicate higher physical fitness'}, {'measure': 'Stability energy', 'timeFrame': 'Baseline', 'description': 'Posturographic parameter, measures economy of movement; higher values mean lower stabilty'}, {'measure': 'Harmony index', 'timeFrame': 'Baseline', 'description': 'Posturographic parameter'}, {'measure': 'Frequency of sway', 'timeFrame': 'Baseline', 'description': 'Posturographic parameter'}, {'measure': 'Feedback', 'timeFrame': 'Baseline', 'description': 'Posturographic parameter; quantitative data; a score is calculated by the posturographic system to determine the influence of visual, vestibular and somatosensory feedback on postural control'}, {'measure': 'Movement control', 'timeFrame': 'Baseline', 'description': 'Posturographic parameter; the frequencies of the movement amplitude during the posturographic measurement are calculated and a score for the low and high frequencies is presented. For the lower frequencies (F1, F2) higher values are positive. For the higher frequencies (F3 - F8) lower values are positive.'}, {'measure': 'Weight distribution index', 'timeFrame': 'Baseline', 'description': 'Posturographic parameter; Center of pressure at beginning of measurement'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Baseline', 'description': 'Relation weight to height'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postural Balance', 'Core Strength', 'Core Stability', 'Physical Fitness']}, 'descriptionModule': {'briefSummary': 'Evaluation of healthy young adults regarding balance, core strength/core stability and physical fitness. Correlation of primary outcome parameters and selected secondary parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy young adults between 18 and 35 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adequat cognitive and lingual competence\n* Written informed consent\n\nExclusion Criteria:\n\n* low back pain or other painful disorders regarding the spine during the last 6 weeks\n* Previous spine surgery\n* Neurologic disease or disease of the vestibular organ\n* Previous arthroplasty of joints'}, 'identificationModule': {'nctId': 'NCT05719532', 'briefTitle': 'Core Strength and Coordinative Skills', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Kepler University of Linz'}, 'officialTitle': 'Correlation of Core Strength/Core Stability and Coordinative Skills in Healthy Adults - an Explorative Study', 'orgStudyIdInfo': {'id': 'PMR_Core_Balance_001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy adults', 'description': 'Healthy adults between 18 and 35 years'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4021', 'city': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Mittermaier, M.D.', 'role': 'CONTACT', 'email': 'christian.mittermaier@kepleruniklinikum.at', 'phone': '+43(0)57680836170'}], 'facility': 'Department of Physical Medicine & Rehabilitation, Kepler University Hospital', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}], 'centralContacts': [{'name': 'Christian Mittermaier, M.D.', 'role': 'CONTACT', 'email': 'christian.mittermaier@kepleruniklinikum.at', 'phone': '+43 5 7680 83', 'phoneExt': '78696'}], 'overallOfficials': [{'name': 'Christian Mittermaier, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kepler University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Kepler University of Linz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kepler University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}