Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT06354803
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Pezzi Ball on Balance in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The drawing procedure was conducted by a researcher without disclosure to the participants, ensuring unbiased allocation. Moreover, both the assessor and statistician remained blinded throughout the assessment period, unaware of the group assignments.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '45 participants with gestational age below 28 weeks'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of postural stability', 'timeFrame': '1 month', 'description': 'By the use of balance check board 636-1 the balance of pregnant women changed significantly which appears in change in the rate of falling'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kinaesthetic training'], 'conditions': ['Postural Stability']}, 'descriptionModule': {'briefSummary': 'The effect of kinaesthetic training on performance and postural stability during pregnancy and 2 weeks postpartum', 'detailedDescription': 'The effect of kinaesthetic training using pezzi ball for 12 sessions with rate of 3 session per week on postural stability and performance during pregnancy and at the 2-week postpartum follow-up. Postural stability was measured using a balance check board 636-1'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Pregnanc women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 25 and 30 years a body mass index (BMI) not exceeding 32 kg/m2, low-risk gestation primiparous pregnancy intact sensory motor integration in the lower extremities.\n\nExclusion Criteria:\n\n* more than 28 weeks gestation\n* had chronic disease\n* multiparous'}, 'identificationModule': {'nctId': 'NCT06354803', 'briefTitle': 'Effect of Pezzi Ball on Balance in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Amelioration of Kinaesthesia in Pregnant Women Using Pezzi Ball Exercises: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KafrelsheikhU 30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': '23 women below 28 week gestation were received kinaesthetic exercises on the Pezzi ball and standard antenatal care', 'interventionNames': ['Other: proprioceptive training']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': '22 women belowe 28 week gestation were received just standard antenatal care'}], 'interventions': [{'name': 'proprioceptive training', 'type': 'OTHER', 'otherNames': ['Standard antenatal care'], 'description': 'Proprioceptive training using swiss ball for 12 sessions', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6850001', 'city': 'Kafr ash Shaykh', 'state': 'Kafrelshiekh', 'country': 'Egypt', 'facility': 'Faculty of physical therapy kafrelshiekh university', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ahmed elsaied moghazy ahmed', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}