Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-26 @ 3:42 PM
Study NCT ID:
NCT06902168
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2025-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Diving and Aquatic Exercises on Muscle Spasticity and Motor Function in Children With Spastic Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-29', 'studyFirstSubmitDate': '2025-03-22', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gross motor function measurement-66', 'timeFrame': '8 weeks after intensive swimming program', 'description': 'The gross motor function measurement-66 (GMFM-66) employs a four-point scoring system for each item. The 66 items are recorded according to the following classification: 0 = child unable to initiate the task; 1 = child initiates the task; 2 = child partially completes the task; 3 = child completes the task; and NT = not tested.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diving', 'Aquatic', 'Muscle Spasticity', 'Motor Function', 'Children', 'Spastic Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of diving and aquatic exercises on muscle spasticity and motor function in children with spastic cerebral palsy.', 'detailedDescription': 'Cerebral palsy (CP) is a common neurological disorders that affect movement and muscle coordination in childhood. Hydrotherapy is one of the most popular supplementary treatments for children with neuro-motor impairments, particularly children with CP.\n\nHydrotherapy may be more suitable for children with CP because of the properties of water, and it may be more motivating for children than land-based exercise. Buoyancy makes it easier for children with moderate to severe mobility limitations to move in the water than to move and exercise on land.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 2 to 5 years.\n* Both sexes.\n* Children diagnosed with spastic cerebral palsy, categorized according to the Gross motor function classification system (GMFCS) levels IV, V.\n\nExclusion Criteria:\n\n* Botulinum toxin treatment or surgery in the preceding three months.\n* Botox injections before or during the application of the program.\n* Dorsal rhizotomy.'}, 'identificationModule': {'nctId': 'NCT06902168', 'briefTitle': 'Effect of Diving and Aquatic Exercises on Muscle Spasticity and Motor Function in Children With Spastic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Effect of Diving and Aquatic Exercises on Muscle Spasticity and Motor Function in Children With Spastic Cerebral Palsy', 'orgStudyIdInfo': {'id': 'RC 4-2-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive swimming program', 'description': 'The participants will be enrolled in an intensive swimming program for 8 weeks (45 minutes) in the swimming pool. The swimming program will be to improve safety and functional independence in the water. The hydrotherapy will be performed at a swimming pool temperature suitable for the weather temperature.', 'interventionNames': ['Other: Intensive swimming program']}], 'interventions': [{'name': 'Intensive swimming program', 'type': 'OTHER', 'description': 'The participants will be enrolled in an intensive swimming program for 8 weeks (45 minutes) in the swimming pool. The swimming program will be to improve safety and functional independence in the water. The hydrotherapy will be performed at a swimming pool temperature suitable for the weather temperature.', 'armGroupLabels': ['Intensive swimming program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13518', 'city': 'Banhā', 'state': 'Benha', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sarah K Banawi, PhD', 'role': 'CONTACT', 'email': 'sarakotb321@gmail.com', 'phone': '00201274908934'}], 'facility': 'Benha University (faculty of physical education)', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'centralContacts': [{'name': 'Sarah K Banawi, PhD', 'role': 'CONTACT', 'email': 'sarakotb321@gmail.com', 'phone': '00201274908934'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD in Philosophy, Faculty of Physical Education, Benha University, Egypt.', 'investigatorFullName': 'Sarah Kotb Banawi', 'investigatorAffiliation': 'Benha University'}}}}