Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 5:35 AM
Study NCT ID:
NCT06927869
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-25
First Post:
2025-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pully System Exercise Role in Management of Spasticity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], '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'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2025-02-11', 'studyFirstSubmitQcDate': '2025-04-12', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'erobic capacity', 'timeFrame': '3 months', 'description': '6m walk test'}], 'primaryOutcomes': [{'measure': 'gross motor function of children with cerebral palsy using GMFMS', 'timeFrame': '3 months', 'description': 'evaluate change that occurs over time in the gross motor function of children with cerebral palsy'}, {'measure': 'pediatric balance scale', 'timeFrame': '3 months', 'description': 'A 14-item criterion-referenced measure that examines functional balance in the context of everyday tasks in the pediatric population.'}], 'secondaryOutcomes': [{'measure': 'spasticity with EMG', 'timeFrame': '3 months', 'description': 'In assessing muscle tone it is important to consider all the inputs and outputs affecting it, using biomechanical-EMG techniques for measuring active tone'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pully system', 'cerebral palsy', 'spasticity'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate the effect of pully system exercise in in management of spasticity in cerebral palsy children\n\nDoes pully system exercise has role in management of spasticity in cerebral palsy children ?\n\nParticipants will:\n\nThe participants assigned to the control group will receive a standard care program. This program is designed to provide basic supportive therapies without the specialized pulley system exercises', 'detailedDescription': 'there are two groups one group will receive traditional physical therapy programme another group will receive pully system exercise'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Inclusion criteria\n* The degree of spasticity is (1) according to Modified Ashwarth's scale\n* They able to understand orders given to them.\n* All children evaluated before and after the suggested period of the physical therapy program (3months).\n\nExclusion Criteria:\n\n* \\- No fixed deformities.\n* They have neither visual nor auditory problems.\n* They have neither perceptual nor cognitive problems."}, 'identificationModule': {'nctId': 'NCT06927869', 'briefTitle': 'Pully System Exercise Role in Management of Spasticity', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Effect of Pully System Exercise in Management of Spasticity in Cerebral Palsy Children: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'KFSIRB200-193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'description': 'the l group will receive a standard care program.', 'interventionNames': ['Other: designed physical therapy , pully system exercise']}, {'type': 'EXPERIMENTAL', 'label': 'study', 'description': 'study group will received pulley system exercises', 'interventionNames': ['Other: designed physical therapy , pully system exercise']}], 'interventions': [{'name': 'designed physical therapy , pully system exercise', 'type': 'OTHER', 'description': 'Participants assigned to the intervention group will engage in a specially designed physical therapy program focusing on pulley system exercises. The program is scheduled to occur three times per week, which is frequent enough to potentially induce meaningful improvements while allowing adequate rest between sessions to prevent fatigue and overtraining', 'armGroupLabels': ['group 1', 'study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Elsalam university', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of pediatric physical therapy', 'investigatorFullName': 'Sara Yousef Abdel Elglil Yousef Elsebahy', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}