Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT05463718
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2022-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality Versus Balance Beam on Spastic Hemiplegic Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2022-06-19', 'studyFirstSubmitQcDate': '2022-07-14', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Balance it will be assist by HUMAC Balance Assessment system', 'timeFrame': '6 month', 'description': 'Evaluation materials that used in assist balance :\n\nHUMAC Balance Assessment system consists of:\n\n1- The force platform 2- The HUMAC CD holding the operating program This test will be use assess the sensory integration of balance and postural control in the conditions of eyes open and eyes closed from standing, lasts for 30 second and the test was repeated for three times and the mean value is calculated from the result of each trial which appears in the form of percent of stability in each trial'}, {'measure': 'Walking ability', 'timeFrame': '6 month', 'description': 'Evaluation materials\n\nSix Minute Walk Test (6MWT) it is a valid and reliable instrumentation using to asses walking capacity The child of this test is to walk as far as possible for 6 minutes. You will walk back and forth in this hallway, after the test, measured walking capacity exercise (BP, HR and SpO2) were re-measured.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Balance Problems in Spastic Hemiplegic Children', 'Walking Performance in Spastic Hemiplegic Children']}, 'descriptionModule': {'briefSummary': 'Is there any difference between the use of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children?', 'detailedDescription': 'To compare the effect of Virtual reality and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.\n\nTo compare the effect of Balance beam and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.\n\nTo compare the effect of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ranges from 7 to 11 years old, from both genders.\n* Modified Ashworth scale adopted from, (Bohannon and Smith,1987) was used to select the patients with grade 1 and 1+ of Spasticity.\n* They were able to stand and walk.\n* Gross motor function measure scale GMFM (level I \\&II). (Russell et al. ,2013).\n* Children with good mentality to understand the evaluation steps.\n\nExclusion Criteria:\n\n* Children who have orthopedic surgery or Botulinum Toxin-A injection in the last 6 months.\n* Children who have any spinal deformities.\n* Children with severe muscle contracture.'}, 'identificationModule': {'nctId': 'NCT05463718', 'briefTitle': 'Virtual Reality Versus Balance Beam on Spastic Hemiplegic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Virtual Reality Versus Balance Beam on Walking Performance in Children With Spastic Hemiplegic Cerebral Palsy', 'orgStudyIdInfo': {'id': '012/003683'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'children treated by the traditional physical therapy program based on Neurodevelopmental technique', 'description': 'Twenty-five cerebral palsied hemiplegic children will be treated by the traditional physical therapy program ( balance board, single limb support, standing with throwing ball ) based on Neurodevelopmental technique for 6 month', 'interventionNames': ['Device: Virtual Reality']}, {'type': 'EXPERIMENTAL', 'label': 'children treated by Virtual Reality for 15 min. besides the traditional physical therapy program', 'description': 'twenty-five cerebral palsied hemiplegics will be included in this group; they will be receive the regular physical therapy program in addition to training by Virtual reality with use of the HMD helmet allows users to perceive a 3D stereoscopic images that enable participants to interact with different balance games as football Soccer, football heading (known as Soccer Heading), the tight rope walks and the Penguin slide game.', 'interventionNames': ['Device: Virtual Reality']}, {'type': 'EXPERIMENTAL', 'label': 'children treated by Balance Beam for 15 min besides the traditional physical therapy program', 'description': 'Twenty-five cerebral palsied hemiplegics will be included in this group; they will be receive the regular physical therapy program in addition to training by standing and walking in balance beam by differentiate levels of walking balance proficiency as varying widths of beam and walking in different direction (forward or backward).', 'interventionNames': ['Device: Virtual Reality']}], 'interventions': [{'name': 'Virtual Reality', 'type': 'DEVICE', 'description': 'children treated by Virtual Reality for 15 min. besides the traditional physical therapy program', 'armGroupLabels': ['children treated by Balance Beam for 15 min besides the traditional physical therapy program', 'children treated by Virtual Reality for 15 min. besides the traditional physical therapy program', 'children treated by the traditional physical therapy program based on Neurodevelopmental technique']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'NOT_YET_RECRUITING', 'country': 'Egypt', 'facility': 'Physical Therapy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'physical therapy, doctoral', 'role': 'CONTACT', 'email': 'un.grad@pt.cu.edu.eg', 'phone': '02 37617691'}], 'facility': 'Physical Therapy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Pediatrics department, Faculty of Physical Therapy, Cairo University', 'investigatorFullName': 'Mohanad Mohsen Madboly Elsayed', 'investigatorAffiliation': 'Cairo University'}}}}