Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-26 @ 2:26 PM
Study NCT ID:
NCT06270550
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2024-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Dynamic Movement Intervention 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2024-02-19', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Dynamic movement intervention on balance and quality of walking of the study group compared to control group, measured using Humac Balance System.', 'timeFrame': 'Baseline', 'description': 'Effect of Dynamic movement intervention on balance and quality of walking of the study group compared to control group with different intervention.\n\nAs balance will be assessed using Humac Balance System.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dynamic Movement Intervention'], 'conditions': ['Spastic Diplegia']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the effect of dynamic movement intervention approach on static and dynamic balance, quality of step length and cadence of walking pattern of children with spastic diplegic cerebral palsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age ranged from 4-7 years.\n* They can walk alone short distance and climb stairs holding on rail (Grade I \\& II according to GMFCS).\n* They can understand and execute instructions.\n* They will be medically stable.\n* Degree of spasticity will be ranged from 1 to 1+ degree according to the Modified Ashworth Scale.\n\nExclusion criteria:\n\n* Visual impairment (visual loss- cataract- myopia- hyperopia).\n* Hearing impairment (deafness)\n* Cognitive problem.\n* Uncontrolled Convulsions.\n* Orthopedic surgery for the affected lower limbs within one year.\n* Botulinum toxin injection within the last 6 months or within the study period.'}, 'identificationModule': {'nctId': 'NCT06270550', 'briefTitle': 'Role of Dynamic Movement Intervention in Children with Spastic Diplegia', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Dynamic Movement Intervention on Children with Spastic Diplegia', 'orgStudyIdInfo': {'id': 'DMI in Spastic Diplegia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dynamic movement intervention based group.', 'interventionNames': ['Other: Dynamic Movement Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Selective physical therapy program based group.', 'interventionNames': ['Other: Dynamic Movement Intervention']}], 'interventions': [{'name': 'Dynamic Movement Intervention', 'type': 'OTHER', 'description': 'Dynamic movement intervention is a physical therapy approach for infants suffering abnormal developmental motor evolution caused by a known or unknown non-degenerative syndrome affecting the central nervous system', 'armGroupLabels': ['Dynamic movement intervention based group.', 'Selective physical therapy program based group.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mahmoud Awara, B.Sc', 'role': 'CONTACT', 'email': 'crawara07@gmail.com', 'phone': '+201013829575'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Bachelor's degree in Physical Therapy", 'investigatorFullName': 'Mahmoud Abdel Aziz Abdel Aziz Awara', 'investigatorAffiliation': 'Cairo University'}}}}