Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-03-04 @ 10:28 AM
Study NCT ID:
NCT07228806
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Telerehabilitation on Pelvic Floor Dysfunction at Postpartum Woman
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069350', 'term': 'Telerehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic floor muscle strength assessment', 'timeFrame': 'Before exercises programme and 8th week of exercises programme', 'description': 'Pelvic floor muscle strength assessment using the SineBravo 2-channel EMG Biofeedback device'}], 'secondaryOutcomes': [{'measure': 'Measurement of the distance between the inferior edge of the pubic symphysis and the anteromedial edge of the puborectalis muscle using transperineal ultrasound', 'timeFrame': 'Before exercises programme and 8th week of exercises programme'}, {'measure': 'Pelvic floor questionnaire for pregnant and postpartum women', 'timeFrame': 'Before exercises programme and 8th week of exercises programme'}, {'measure': 'Female Sexual Function Index', 'timeFrame': 'Before exercises programme and 8th week of exercises programme'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postpartum Woman', 'Pelvic Floor Dysfunction', 'Telerehabilitation'], 'conditions': ['Postpartum Pelvic Floor Function and Symptoms']}, 'descriptionModule': {'briefSummary': "These events are largely due to pelvic floor dysfunction that develops after pregnancy. Kegel exercises and core stabilisation exercises performed in the postpartum period are important in preventing pelvic floor dysfunction. However, considering the mother's adaptation process to both the baby and her new life in the postpartum period, there may be problems with exercise compliance. Increasing exercise compliance through telerehabilitation can be effective in preventing pelvic floor dysfunction and improving women's quality of life."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged between 18 and 45\n2. Primiparous women\n3. Term vaginal delivery\n4. 6 weeks postpartum\n5. Willingness to participate in the study\n\nExclusion Criteria:\n\n1. Presence of faecal or urinary incontinence prior to pregnancy\n2. Use of assisted delivery devices (vacuum, forceps)\n3. Presence of neurological disease\n4. Presence of psychiatric illness or cognitive problems that make it difficult to answer questions\n5. Caesarean section delivery\n6. History of diabetes mellitus\n7. Perineal rupture'}, 'identificationModule': {'nctId': 'NCT07228806', 'briefTitle': 'Effectiveness of Telerehabilitation on Pelvic Floor Dysfunction at Postpartum Woman', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Etlik City Hospital'}, 'officialTitle': 'Evaluation of the Effectiveness of Telerehabilitation on Pelvic Floor Dysfunction in Postpartum Women: A Single-Blind Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'AEŞH-EK-2025-062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation group', 'interventionNames': ['Other: Pelvic floor exercises with telerehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional group', 'interventionNames': ['Other: Pelvic floor exercises without telerehabilitation']}], 'interventions': [{'name': 'Pelvic floor exercises with telerehabilitation', 'type': 'OTHER', 'description': 'Patients in the telerehabilitation group will be assigned the same 8-week exercise programme as those in the conventional group to be carried out at home. Unlike the conventional group, patients in the telerehabilitation group will be contacted by telephone each week throughout the exercise programme to check their adherence to the programme, to ask if they have encountered any problems with the exercise programme, and to answer any questions they may have.', 'armGroupLabels': ['Telerehabilitation group']}, {'name': 'Pelvic floor exercises without telerehabilitation', 'type': 'OTHER', 'description': 'An 8-week exercise programme consisting of 45-minute Kegel exercises and core stabilisation exercises per day will be provided for implementation at home in the conventional group.', 'armGroupLabels': ['Conventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'state': 'Yenimahalle', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ayşe Naz Kalem Özgen', 'role': 'CONTACT', 'email': 'kalemnaz@gmail.com', 'phone': '+90 0312 797 00 00'}], 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ayşe Naz Kalem Özgen, specialist', 'role': 'CONTACT', 'email': 'kalemnaz@gmail.com', 'phone': '+90 0312 797 00 00'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PM&R Specialist', 'investigatorFullName': 'Ayse Naz Kalem', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}