Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-31 @ 9:36 PM
Study NCT ID:
NCT05125666
Status:
UNKNOWN
Last Update Posted:
2021-11-18
First Post:
2021-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001259', 'term': 'Ataxia'}, {'id': 'D008527', 'term': 'Medulloblastoma'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-06', 'studyFirstSubmitDate': '2021-10-02', 'studyFirstSubmitQcDate': '2021-11-06', 'lastUpdatePostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Static balance of patients with ataxia after resection measured by center of pressure using force plate mode in the humac balance system.', 'timeFrame': '2 months'}, {'measure': 'Improvement in dynamic balance of patients with ataxia after resection measured by using tilt mode in the humac balance system.', 'timeFrame': '2 months'}, {'measure': 'Improvement in Activities of Daily Living (ADL) measured by functional independence measurement.', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ataxia', 'Medulloblastoma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of using a selected dual-task- training program to improve postural stability in children with ataxia after medulloblastoma resection. Thirty patients will participate in this study. Patients will be classified randomly into two equal groups: study and control groups -Both groups will receive conventional physical therapy treatment including mobility exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning. In addition, the study group will receive a selected dual-task training program including balance and cognitive activities. The treatment program will be conducted three days per week for eight successive weeks. The patients will be assessed with the Scale of Assessment and Rating of Ataxia, Humac Balance System, the Pediatric Balance Scale and Functional Independent Measurement. The measures will be recorded two times: before the application of the treatment program (pre) and after the end of the treatment program (post).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll children with the following criteria will be in rolled in the study\n\n1. Age range from (5-10 years).\n2. Severity of ataxia will be from 15-30 by SARA scale.\n3. Children after 2 months of medulloblastoma resection.\n4. They can stand and walk with minimal support.\n5. They have good cognition, compliance, and ability to understand and instructions.\n6. Children receiving radiotherapy and chemotherapy sessions\n7. They are medically stable\n\nExclusion Criteria:\n\nChildren will be excluded from the study if they have\n\n1. Any neuromuscular disorder.\n2. Visual impairment.\n3. Cognitive problem\n4. Convulsion.\n5. Peripheral neuropathy due to chemotherapy.'}, 'identificationModule': {'nctId': 'NCT05125666', 'briefTitle': 'Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection: (A Randomized Controlled Trial)', 'orgStudyIdInfo': {'id': 'DTT-Ataxia-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dual Task Training', 'interventionNames': ['Other: Dual Task Training (Motor + Cognitive)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ordinary Physical Therapy for Ataxia', 'interventionNames': ['Other: Traditional Regular Exercise']}], 'interventions': [{'name': 'Dual Task Training (Motor + Cognitive)', 'type': 'OTHER', 'description': 'Each child in this group will perform one-hour session consist of two tasks (cognitive and balance task) in addition to the traditional physical therapy program three times weekly for 8 successive weeks.', 'armGroupLabels': ['Dual Task Training']}, {'name': 'Traditional Regular Exercise', 'type': 'OTHER', 'description': 'Each child in this group will receive the selected physical therapy program which include mobility exercises, strengthening exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning for one-hour session three times weekly for 8 successive weeks.', 'armGroupLabels': ['Ordinary Physical Therapy for Ataxia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'El Sayeda Zainab', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Moatsem El Ayadi, MD', 'role': 'CONTACT'}], 'facility': '57357 Children Cancer Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Fatma M Sedeek, BSc', 'role': 'CONTACT', 'email': 'ptfatmaselim@gmai.com', 'phone': '01201980290'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Fatma Mostafa Sedeek Selim', 'investigatorAffiliation': 'Cairo University'}}}}