Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-29 @ 7:44 PM
Study NCT ID:
NCT06601569
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Range of Motion and Balance Abnormalities in Children Diagnosed with 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': 'D016059', 'term': 'Range of Motion, Articular'}], 'ancestors': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-29', 'studyFirstSubmitDate': '2024-07-27', 'studyFirstSubmitQcDate': '2024-09-15', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'predictors of range of motion and balance abnormalities', 'timeFrame': 'from 1 august 2024 to 1 october 2024', 'description': 'the aim of the study is to investigate the predicted cause if the range of motion abnormalities measured by (spinal alignment and range of motion assessment scale ) and balance abnormalities ( measured by early clinical assessment of balance scale )in children with cerebral palsy like muscle strength (measured by functional muscle strength scale) and muscle tone changes (measured by modified athwart scale)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': '1. To better understand the factors that contribute to ROM abnormalities in children diagnosed with CP.\n2. To describe the distribution of primary (muscle tone and postural stability)and secondary impairments (ROM and functional muscle strength) across the gross motor spectrum measured by GMFCS scores.\n3. To evaluate the effects of primary and secondary impairments on gross functional outcome in children with spastic CP.\n4. To find any possible correlation between clinical variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '18 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children with cerebral plasy their age ranged fro 18 month t 5 yeas old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* only children with clinical diagnosis of cerebral palsy , who were receiving physiotherapy services at the paediatric out-patient clinic of Faculty of Physical Therapy, Cairo University for a minimum of six months regularly.\n\nExclusion Criteria:\n\n* Children were excluded if they had one or more of the following: behavioral issues, a history of persistent heart or chest disease, significant visual or auditory impairment, botulinum toxin injection at last six months prior to the study.'}, 'identificationModule': {'nctId': 'NCT06601569', 'briefTitle': 'Predictors of Range of Motion and Balance Abnormalities in Children Diagnosed with Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Predictors of Range of Motion and Balance Abnormalities in Children Diagnosed with Cerebral Palsy', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005209'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diplegic cerebral palsy', 'interventionNames': ['Diagnostic Test: balance and range of motion']}, {'label': 'quadripledic cerebral palsy', 'interventionNames': ['Diagnostic Test: balance and range of motion']}, {'label': 'hemiplegic cerebral palsy', 'interventionNames': ['Diagnostic Test: balance and range of motion']}, {'label': 'dyskinetic cerebral palsy', 'interventionNames': ['Diagnostic Test: balance and range of motion']}], 'interventions': [{'name': 'balance and range of motion', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Spinal alignment and range of motion measure scale', 'Modified Ashworth scale (MAS)', 'Early clinical assessment of balance (ECAB) scale', 'Functional strength assessment scale'], 'description': '* Spinal alignment and range of motion measure scale (SAROMM): is a measure of spinal alignment and range of motion using standard physical therapy techniques scored on a 5-point ordinal score of 0 (normal alignment and range with active correction) to4 ("severe" fixed deformity) (Bartlett ey al., 2005)\n* Modified Ashworth scale (MAS): is a measure of muscle motion and scoring the perceived resistance to movement on a scale of 1 (no increase in tone) to 5 (rigid in flexion or extension) (Clopton et al., 2005).\n* Early clinical assessment of balance (ECAB) scale: Is a 13-item test that estimates postural stability for children with CP across all levels of functional ability (Jeffries etal., 2016).\n* Functional strength assessment scale: Therapists completed a functional strength assessment (FSA) to obtain an estimate of strength for major muscle groups including the neck and trunk flexors and extensors, and hip extensors, knee extensors, and shoulder flexors bilaterally.', 'armGroupLabels': ['diplegic cerebral palsy', 'dyskinetic cerebral palsy', 'hemiplegic cerebral palsy', 'quadripledic cerebral palsy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mahmoud usama', 'role': 'CONTACT', 'email': 'afekry335@gmail.com', 'phone': '+21285221209'}], 'facility': 'Faculty of Physical Therapy Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'ahmed fekry salman', 'role': 'CONTACT', 'email': 'a.salman@ammanu.edu.jo', 'phone': '+201067873174'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor physical therapy department', 'investigatorFullName': 'Ahmed fekry ibrahim salman', 'investigatorAffiliation': 'Cairo University'}}}}