Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-27 @ 7:41 AM
Study NCT ID:
NCT05227066
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2022-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562856', 'term': 'Cerebral Palsy, Ataxic, Autosomal Recessive'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2022-02-04', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in overall stability index', 'timeFrame': 'baseline and after 3 months of intervention.', 'description': 'change in overall stability index will measured by using biodex balance system'}], 'secondaryOutcomes': [{'measure': 'antero-posterior stability index', 'timeFrame': 'baseline and after 3 months of intervention.', 'description': 'change in antero-posterior stability index will measured by using biodex balance system'}, {'measure': 'mediolateral stability index', 'timeFrame': 'baseline and after 3 months of intervention.', 'description': 'change in mediolateral stability index will measured by using biodex balance system'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ataxic Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Some also have trouble with depth perception This means being able to accurately judge how close or far away something is'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ataxic cerebral palsy aged 7-13 years\n\nExclusion Criteria:\n\n* any musculoskeletal conditions that affect balance previous surgeries that affecting balance'}, 'identificationModule': {'nctId': 'NCT05227066', 'briefTitle': 'Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Delta University for Science and Technology'}, 'officialTitle': 'Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy', 'orgStudyIdInfo': {'id': 'Ataxic CP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'traditional physical therapy group', 'description': 'received traditional physical therapy protocol', 'interventionNames': ['Other: traditional physical therapy group']}, {'type': 'EXPERIMENTAL', 'label': 'lower extremity weights group', 'description': 'received the same traditional physical therapy in addition to lower extremity weights', 'interventionNames': ['Other: adding lower extremity weights', 'Other: traditional physical therapy group']}], 'interventions': [{'name': 'adding lower extremity weights', 'type': 'OTHER', 'description': 'All children in the two groups received physical therapy protocol for 30 minutes in addition to half kg of sandbags weights attached for each leg', 'armGroupLabels': ['lower extremity weights group']}, {'name': 'traditional physical therapy group', 'type': 'OTHER', 'description': 'traditional physical therapy group', 'armGroupLabels': ['lower extremity weights group', 'traditional physical therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4030', 'city': 'Gamasa', 'state': 'Dakahelia', 'country': 'Egypt', 'facility': 'Delta University for Science and Technology', 'geoPoint': {'lat': 31.44112, 'lon': 31.53675}}], 'overallOfficials': [{'name': 'Hala I. Kassem, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of physical therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Delta University for Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of physical therapy', 'investigatorFullName': 'walaa eldesoukey heneidy', 'investigatorAffiliation': 'Delta University for Science and Technology'}}}}