Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-24 @ 9:24 AM
Study NCT ID:
NCT06492603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examination of Biomechanical Characteristics of Linea Alba in Diastasis Recti Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Linea Alba Stiffness', 'timeFrame': 'Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum', 'description': 'It is a Biomechanical Characteristic of the Linea Alba'}, {'measure': 'Linea Alba Elasticity', 'timeFrame': 'Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum', 'description': 'It is a Biomechanical Characteristic of the Linea Alba'}, {'measure': 'Linea Alba Creep', 'timeFrame': 'Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum', 'description': 'It is a Viscoelastic Characteristic of the Linea Alba'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Separated Recti Abdominis']}, 'descriptionModule': {'briefSummary': 'Diastasis recti is an increased distance between the rectus abdominis muscles at the midline caused by weakness in the anterior abdominal wall.', 'detailedDescription': 'Most healthcare providers agree that in diastasis rectus abdominis there is a weakness, thinning, and widening of the linea alba and weakness of the associated abdominal musculature.\n\nUltrasonography is regarded as the most accurate method for measuring the IRD and its results are consistent with the data derived from palpation, calipers, and intraoperative measurements.\n\nThe MyotonPRO Device is used for the non-invasive measurement of Device is for the non-invasive measurement of biomechanical and viscoelastic properties of superficial soft biological tissues. Skeletal muscles or tendons can be measured at different regions, at full rest or in contraction.\n\nThis study aims to assess the biomechanical and viscoelastic properties of the Linea Alba in patients who are diagnosed with diastasis rectus abdominis by ultrasonography.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '40 post-Cesarean women who are diagnosed with or without diastasis rectus abdominis. They will be selected from the teaching Hospitals of South Valley University.', 'genderDescription': 'This study examines the Biomechanical and Viscoelastic Characteristics of Diastasis Rectus Abdominis in Postpartum Women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postpartum Mothers who delivered by a cesarean section.\n* Postpartum Mothers with a BMI below 30 or a Waist-hip ratio below 1.\n* Postpartum Mothers above 18 years old and those below 40 years old.\n\nExclusion Criteria:\n\n* Postpartum Mothers who delivered by a vaginal delivery.\n* Postpartum Mothers who had hernias in the abdominal region or laparotomy.\n* Postpartum Mothers with a BMI over 30 or a Waist-hip ratio over 1.\n* Postpartum Mothers below 18 years old and those above 40 years old.'}, 'identificationModule': {'nctId': 'NCT06492603', 'briefTitle': 'Examination of Biomechanical Characteristics of Linea Alba in Diastasis Recti Patients', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Examination of Linea Alba Biomechanical and Viscoelastic Characteristics in Patients Diagnosed With Diastasis Recti Using Ultrasound', 'orgStudyIdInfo': {'id': 'Diastasis Recti'}}, 'armsInterventionsModule': {'armGroups': [{'label': '20 Women in the Postpartum Diastasis Recti Group', 'interventionNames': ['Device: Ultrasonography', 'Device: The MyotonPRO Device']}, {'label': '20 Women in the Control Group (Postpartum Without Diastasis Recti)', 'interventionNames': ['Device: Ultrasonography', 'Device: The MyotonPRO Device']}], 'interventions': [{'name': 'Ultrasonography', 'type': 'DEVICE', 'description': 'Ultrasound is an assessment device that uses high-energy sound waves to look at either superficial tissues like linea alba and/or organs inside the body. The sound waves make echoes that form pictures of the tissues and organs on a computer screen (sonogram).', 'armGroupLabels': ['20 Women in the Control Group (Postpartum Without Diastasis Recti)', '20 Women in the Postpartum Diastasis Recti Group']}, {'name': 'The MyotonPRO Device', 'type': 'DEVICE', 'description': 'The MyotonPro is a portable device for measuring biomechanical and viscoelastic properties in superficial soft tissues', 'armGroupLabels': ['20 Women in the Control Group (Postpartum Without Diastasis Recti)', '20 Women in the Postpartum Diastasis Recti Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed G Shehata, Lecturer', 'role': 'CONTACT', 'email': 'dr_m.gamal1987@svu.edu.eg', 'phone': '01014397608'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Lecturer of Physical Therapy for Women's Health", 'investigatorFullName': 'Mohamed Gamal Abouelyazeed Ali', 'investigatorAffiliation': 'South Valley University'}}}}