Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-28 @ 5:20 AM
Study NCT ID:
NCT05014451
Status:
UNKNOWN
Last Update Posted:
2021-10-18
First Post:
2021-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Alignment in Relation to Standing Balance and Selective Motor Control in Children With Spastic Diplegia
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2021-08-14', 'studyFirstSubmitQcDate': '2021-08-14', 'lastUpdatePostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic alignment in relation to dynamic standing balance', 'timeFrame': '2 months', 'description': 'Pelvic alignment will be assessed using the Formetric system, while standing balance will be assessed using the Biodex system then results will be compared to find the relation between pelvic alignment and dynamic standing balance in children with diplegia.'}, {'measure': 'Pelvic alignment in relation to selective voluntary motor control of the lower extremities', 'timeFrame': '2 month', 'description': 'Pelvic alignment will be assessed using the Formetric system, while selective motor control (SMC) of lower extremities will be assessed using Selective Control Assessment of the Lower Extremity scale (SCALE) then results will be compared to find the relation between pelvic alignment and selective motor control in children with diplegia.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pelvic alignment', 'pelvic tilt, torsion, inclination', 'Formetric', 'Biodex', 'dynamic balance', 'selective motor control', 'SCALE'], 'conditions': ['Cerebral Palsy', 'Spastic Diplegia']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to identify the relation between pelvic alignment and standing balance and also the relation between pelvic alignment and selective motor control in children with spastic diplegic cerebral palsy.', 'detailedDescription': 'In this study, pelvic alignment of children with diplegia will be evaluated using the Formetric instrument system. Their standing balance will be evaluated using the Biodex balance system, while selective voluntary motor control of lower extremities will be assessed using the Selective Control Assessment of the Lower Extremity scale (SCALE).\n\nResults will be compared to find the correlation between pelvic alignment and standing balance and the correlation between pelvic alignment and selective motor control. Results can help clinicians to better address the problems of pelvic asymmetry in children with spastic diplegia to improve their overall balance and functional abilities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with spastic diplegia, their height will not be less than 1 meter to meet the requirements of assessment by the Biodex and Formetric systems. They will be able to stand without the use of an assistive device and they will be able to follow instructions and understand given orders.', 'healthyVolunteers': False, 'eligibilityCriteria': "Forty children with spastic diplegia of both sexes will be selected with the following criteria:\n\nInclusion Criteria:\n\n1. Their age will be ranged from 6 to 8 years.\n2. The degree of their spasticity will be ranged from 1 to 1+ according to Modified Ashworth' Scale.\n3. They will be on level Ⅰ or Ⅱ on Growth Motor Function Classification System (GMFCS).\n\nExclusion Criteria:\n\nThe Children will be excluded if they have one of the following:\n\n1. Severe visual or hearing impairment.\n2. Fixed deformities or surgical interventions in the lower extremities.\n3. Botulinum toxin injections in the last 6 months."}, 'identificationModule': {'nctId': 'NCT05014451', 'briefTitle': 'Pelvic Alignment in Relation to Standing Balance and Selective Motor Control in Children With Spastic Diplegia', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Pelvic Alignment in Relation to Standing Balance and Selective Motor Control in Children With Spastic Diplegia', 'orgStudyIdInfo': {'id': 'P.T.REC/012/003257'}}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The data will be available after completion of statistical analysis of the results.', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication will be shared.', 'accessCriteria': 'The data will be shared upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching assistant', 'investigatorFullName': 'Naglaa Ezzat Abd Allah Mahmoud', 'investigatorAffiliation': 'Cairo University'}}}}