Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05614167
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2022-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Between Isometric Muscle Strength and Gross Motor Function in Children With Unilateral Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-08', 'studyFirstSubmitDate': '2022-11-05', 'studyFirstSubmitQcDate': '2022-11-05', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gross motor function measure', 'timeFrame': '3 months', 'description': 'standing and walking domain'}, {'measure': 'Isometric muscle strength', 'timeFrame': '3 months', 'description': 'a handheld dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemiplegia', 'Cerebral Palsy', 'muscle stength', 'gmfm'], 'conditions': ['Hemiplegia', 'Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Muscle strength can be defined as the ability of skeletal muscle to develop force for the purpose of providing stability and mobility within the musculoskeletal system, so that functional movement can take place.', 'detailedDescription': 'Cerebral palsy describes a group of disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fatal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, cognition, communication, perception, and/or behaviour, and/or by a seizure disorder\n\nThe development and changes in motor function, both natural and with therapy, can be assessed using the Gross Motor Function Measure (GMFM) created for children with CP'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Muscle weakness was found in children with CP, increasing with severity of gross motor function, approximately 50% of the predicted muscle strength was needed to be able to walk without aids.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Their age between 6 and 12 years old.\n2. Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987).\n3. They could walk with limitation or holding on according to GMFCS (level I, II) (Palisano et al., 1997).\n4. They were able to understand and follow verbal instructions.\n\nExclusion Criteria:\n\n1. Children with any visual or auditory problems.\n2. Children with any surgical interference in the lower limb.\n3. Children with any structural deformities in joints and bones of lower limbs.\n4. Children with any special medications affecting muscle functions (anti-spastic drugs).\n5. Children who suffer from other diseases or associated disorders that interfered with physical activity.'}, 'identificationModule': {'nctId': 'NCT05614167', 'briefTitle': 'Relationship Between Isometric Muscle Strength and Gross Motor Function in Children With Unilateral Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Badr University'}, 'officialTitle': 'Relationship Between Isometric Muscle Strength and Gross Motor Function in Children With Unilateral Cerebral Palsy', 'orgStudyIdInfo': {'id': 'Omnya3'}}, 'armsInterventionsModule': {'interventions': [{'name': 'correlation', 'type': 'OTHER', 'description': 'A total of 97 children with CP between the ages of six and 12 years participated in the study. Muscle strength was measured with a handheld dynamometer. Motor function in children with CP was classified with the Gross Motor Function Classification System (GMFCS), graded with the Gross Motor Function Measure (GMFM)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Badr University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Omnya samy, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'lecturer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'private'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Badr University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, Department of Physical Therapy for Pediatrics and Pediatric Surgery, Faculty of Physical Therapy, Badr University in Cairo, Egypt.', 'investigatorFullName': 'Omnya Samy Abdallah Ghoneim', 'investigatorAffiliation': 'Badr University'}}}}