Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-01-01 @ 5:20 AM
Study NCT ID:
NCT07072533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-18
First Post:
2025-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Blood Flow Restriction With Aerobic Training on Chest Muscles in Diaplegic Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090003', 'term': 'Blood Flow Restriction Therapy'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'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': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A which is the experimental group treated with blood flow restriction plus aerobic training and group B which is the control group treated with aerobic trainin only.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2025-06-28', 'studyFirstSubmitQcDate': '2025-07-09', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chest muscle strength', 'timeFrame': '3 months', 'description': 'chest muscle strength will be measured by handheld dynamometry measured in Newton'}], 'secondaryOutcomes': [{'measure': 'pulmonary function tests', 'timeFrame': '3 months', 'description': 'pulmonary function tests in the form of forced vital capacity and forced expiratory volume in one second will be measured in Liters'}, {'measure': 'sub-maximal aerobic capacity', 'timeFrame': '3 months', 'description': 'sub-maximal aerobic capacity will be measured using six minute walk test measured in seconds'}, {'measure': 'quality f life', 'timeFrame': '3 months', 'description': 'quality f life will be measured using the pediatric quality of life inventory measured in scores from zero point to four points'}, {'measure': 'oxygen saturation and heart rate response', 'timeFrame': '3 months', 'description': 'oxygen saturation and heart rate response will be measured using pulse oximeter measured in percentage for oxygen saturation and pulses per minute for heart rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy Spastic Diplegia']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of blood flow restriction combined with aerobic training on chest muscle strength in individual with diaplegic cerebral palsy', 'detailedDescription': 'combining blood flow restriction with aerobic training may enhance muscle function and endurance by increasing localized metabolic stress and systemic cardiovascular effects inducing muscular hypertrophy and strength gaining with low load training especially chest muscles which affected in individuals with diaplegic cerebral palsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ndiaplegic cerebral palsy. GMFCS level I-III. medically stable.\n\nExclusion Criteria:\n\nsevere cognitive impairment. cardio respiratory contraindication. previous thoracic surgery or musculoskeletal deformities affecting chest.'}, 'identificationModule': {'nctId': 'NCT07072533', 'briefTitle': 'Effect of Blood Flow Restriction With Aerobic Training on Chest Muscles in Diaplegic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Blood Flow Restriction With Aerobic Training on Chest Muscles in Diaplegic Cerebral Palsy', 'orgStudyIdInfo': {'id': 'SREC.PT.SUE(11)625'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'blood flow restriction combined with aerobic training', 'description': 'individual will do blood flow restriction aerobic training', 'interventionNames': ['Other: blood flow restriction training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'aerobic training only', 'description': 'individual will do aerobic training', 'interventionNames': ['Other: blood flow restriction training']}], 'interventions': [{'name': 'blood flow restriction training', 'type': 'OTHER', 'otherNames': ['aerobic training'], 'description': 'individual will do aerobic training .', 'armGroupLabels': ['aerobic training only', 'blood flow restriction combined with aerobic training']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Salah Eid Ahmed Ali, Assis Lect', 'role': 'CONTACT', 'email': 'Salah.Eid@sue.edu.eeg', 'phone': '01158125773'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Salah Eid Ahmed Ali', 'investigatorAffiliation': 'Cairo University'}}}}