Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-05 @ 9:23 PM
Study NCT ID:
NCT06621667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragmatic Myofascial Release for Hyperkyphotic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007738', 'term': 'Kyphosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2024-09-29', 'studyFirstSubmitQcDate': '2024-09-30', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum voluntary ventilation', 'timeFrame': 'change from base line at 4 weeks.', 'description': 'the maximum voluntary ventilation will be measured using spirometer'}], 'secondaryOutcomes': [{'measure': 'Chest expansion', 'timeFrame': 'change from base line at 4 weeks.', 'description': 'the chest expansion will be measured using tap measurement'}, {'measure': 'kyphotic angle', 'timeFrame': 'change from base line at 4 weeks.', 'description': 'the kyphotic angle will be measured with flexicurve'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperkyphosis']}, 'descriptionModule': {'briefSummary': "kyphotic subjects have respiratory disturbances due to weakening of the diaphragm, responsible for inhalation, which lead to abnormalities in respiratory mechanics and abnormal gas exchange, leading to respiratory complications. Myofascial release of the diaphragm is an intervention intended to indirectly stretch the diaphragm muscle fibers to reduce muscle tension, normalize fiber length, and promote the efficiency of muscle contraction. Although diaphragm myofascial release has been used in clinical practice, to the best of the authors' knowledge, the current study is the first research investigating the effect of diaphragmatic myofascial release on lung function, chest mobility and kyphotic curve in hyperkyphotic subjects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The participant's age ranged from 20 to 40 years.\n* kyphosis angle 40-50◦\n* reporting pain on palpation of the diaphragm\n\nExclusion Criteria:\n\n* A history of respiratory diseases, heart disease, vascular disease, central nervous system disorder, psychiatric disorders, hypertension.\n* History of any trauma or fracture to the thoracic spine.\n* inflammatory diseases such as rheumatoid arthritis, musculoskeletal problem and neurological deficit\n* Restrictive respiratory disease, smokers."}, 'identificationModule': {'nctId': 'NCT06621667', 'briefTitle': 'Diaphragmatic Myofascial Release for Hyperkyphotic Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Response of Lung Function, Chest Mobility, and Kyphotic Curve to Diaphragmatic Myofascial Release in Hyperkyphotic Subjects: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'myorelease for hyperkyphosis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'interventionNames': ['Other: diaphragmatic myofascial release with traditional physical therapy exercises for hyperkyphosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'interventionNames': ['Other: traditional physical therapy exercises for hyperkyphosis']}], 'interventions': [{'name': 'diaphragmatic myofascial release with traditional physical therapy exercises for hyperkyphosis', 'type': 'OTHER', 'description': 'diaphragmatic myofascial release', 'armGroupLabels': ['study group']}, {'name': 'traditional physical therapy exercises for hyperkyphosis', 'type': 'OTHER', 'description': 'traditional physical therapy exercises for hyperkyphosis', 'armGroupLabels': ['control group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistance professor doctor', 'investigatorFullName': 'Marwa Shafiek Mustafa Saleh', 'investigatorAffiliation': 'Cairo University'}}}}