Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 8:08 AM
Study NCT ID:
NCT06842212
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-24
First Post:
2025-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance Training To Enhance Stability And Athletic Performance During The Menstrual Cycle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2025-01-23', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Balance', 'timeFrame': '12 weeks', 'description': 'biodex balance system device to measure balance Anterior posterior Stability index (APSI) This index is calculated using the degree of oscillation of the platform, in which low values indicated that the individual had good stability.'}], 'secondaryOutcomes': [{'measure': 'atheletic performance', 'timeFrame': '12 weeks', 'description': 'atheletic subjective performance scale\n\n* asking participants to rate their performance during the past week according to their own opinion.\n* Use the scale between 1-10: 1="not at all satisfied", 10="fully satisfied":'}, {'measure': 'Athletic dynamic balance', 'timeFrame': '12 weeks', 'description': 'Star excursion balance test (SEBT) measure the ability to maintain single leg stance on one leg while reaching as far as possible with the contralateral leg in 8 different directions, When the person demonstrates a significantly decreased reach while standing on the injured limb compared to standing on the healthy limb, the Star Excursion Balance Test has highlighted her loss of dynamic postural control'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menstrual Cycle Phase', 'Athletic Performance', 'Balance Training']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study was done to investigate the effect of balance training on improving balance and athletic performance during menstrual cycle in young athletic females Does balance training improve balance and athletic performance during the menstrual cycle? 60 athletic females will participate in the study. They will be randomly assigned into two groups. Group A will receive balance training on biodex, while group B will be the control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '22 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Menstrual Cycle, young Athletes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Their age will be ranged from 18 to 22. Their BMI will be from 18.5 to 25 kg/cm2 - Athletes\n\nExclusion Criteria:\n\n* free of musculoskeletal or neurological diseases that could affect balance/ taking any medications that affect sex hormones'}, 'identificationModule': {'nctId': 'NCT06842212', 'briefTitle': 'Balance Training To Enhance Stability And Athletic Performance During The Menstrual Cycle', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'Targeted Balance Training During The Menstrual Cycle To Enhance Stability And Athletic Performance: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Balance Training', 'interventionNames': ['Device: Balance Training']}, {'type': 'NO_INTERVENTION', 'label': 'control group'}], 'interventions': [{'name': 'Balance Training', 'type': 'DEVICE', 'description': 'balance training exercises performed on the biodex balance system 3 sessions every week for 12 weeks', 'armGroupLabels': ['Balance Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11852', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'British University in Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}