Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT05740020
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2023-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality in Spider Cage on Gross Motor Performance and Balance 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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-01', 'size': 1422531, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-06-06T13:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GROSS MOTOR PERFORMANCE', 'timeFrame': '3 monthes', 'description': 'we will use Gross Motor Function Measure 88 (GMFM-88) to measure Gross motor performance.\n\nthis score range from (0 to 100 ) zero is the minimum value and 100 is the maximum value'}, {'measure': 'BALANCE', 'timeFrame': '3 monthes', 'description': 'we will use Pediatric Balance Scale (PBS) to measure Balance. this score range from (0 to 56 ) zero is the minimum value and 56 is the maximum value'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'This study will detect the effect of virtual reality in spider cage on gross motor performance and balance in children with spastic diplegia.', 'detailedDescription': "The current study will be directed to investigate effect of virtual reality on gross motor and balance as the weakness of the trunk muscles and lower limb muscles along with spasticity potentially predispose balance and walking issues of children with bilateral spastic CP .\n\nThe balance deficits in children with CP are multifactorial. According to the system's model proposed by Woollacott and Shumway-Cook, multiple systems contribute to postural dysfunction in children with CP. Muscle weakness and stiffness of lower limb muscles account for biomechanical constraints and postural malalignment during standing and functional balancing.\n\nVirtual reality is one of the novel technology-based approaches to treat balance and motor function in children with CP. It utilizes the interactive simulations created in computer hardware and software, in which the children find opportunities to engage in environments appearing real to them .\n\nAfter reviewing the available previous published studies, it was found that there is no previous study directly compared between the effects of virtual reality and physical therapy in spider cage on gross motor performance and balance with diplegic children CP children. Both therapeutic modalities were found to induce good clinical outcomes when studied separately, so this study will be conducted to examine the effectiveness of virtual reality.\n\nThe greater demand for physical therapy for Paediatrics' signifies the need for more effective, safer and evident therapeutic modalities. The findings of this study will help both; the therapists and the children to save time, effort and reach the best results in concise times."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children will be included in the study if they fulfil the following criteria:\n\n 1. A medical diagnosis of spastic diplegic CP made by pediatricians or pediatric neurologists.\n 2. Children with spasticity grades ranged from 1 to 2+ according to Modified Ashworth scale (MAS).\n 3. Their age range from 6 to 12 years.\n 4. Children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques.\n\nExclusion Criteria:\n\n* Children with a permanent spastic diplegia, who might have one or more of the following, will be excluded:\n\n 1. They had a permanent deformity (bony or soft tissue contractures).\n 2. Children having visual or auditory defects.\n 3. Current hospitalization for urgent medical reasons.\n 4. Severe mental retardation.\n 5. Children who will undergo fewer than twelve regular sessions of physical therapy at their place will not be included in the survey.\n 6. Children with history of epileptic seizure or any diagnosed cardiac or orthopedic disability that may hinder assessment methods and treatment.'}, 'identificationModule': {'nctId': 'NCT05740020', 'briefTitle': 'Effect of Virtual Reality in Spider Cage on Gross Motor Performance and Balance in Children With Spastic Diplegia', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Effect of Virtual Reality in Spider Cage on Gross Motor Performance and Balance in Children With Spastic Diplegia', 'orgStudyIdInfo': {'id': 'EG, KFS lab Research 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group (A)', 'description': 'Group (A) will receive virtual reality in addition to the traditional exercise program.', 'interventionNames': ['Device: virtual reality glasses', 'Other: The traditional exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group (B)', 'description': 'Group (B) will receive traditional exercise program.', 'interventionNames': ['Other: The traditional exercise program']}], 'interventions': [{'name': 'virtual reality glasses', 'type': 'DEVICE', 'description': 'A specialized VR glasses will be used and VR games application in spider cage', 'armGroupLabels': ['Group (A)']}, {'name': 'The traditional exercise program', 'type': 'OTHER', 'description': 'The selected physical therapy program:\n\n1. Neurodevelopmental approach: aims to facilitate typical motor development and function and to prevent secondary impairments (figure 4).\n2. Approximation: aims to control spasticity and stimulate the joint mechanoreceptors (figure 5).\n3. Stretching exercise: aims to maintain length and flexibility of shorten muscles (figure 6).\n4. Strengthening exercise: aims to improve the functional ability (figure 7).\n5. Spider suspension exercise for 30 minutes (figure 8).\n\n5\\. Gait training activities: aims to improve balance (figure 9). 6. Balance training program: aims to improve balance (figure 10).', 'armGroupLabels': ['Group (A)', 'Group (B)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kafr ash Shaykh', 'state': 'Kafrelsheikh', 'country': 'Egypt', 'facility': 'Physical Therapy', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amr Mohsen Mohamed Abo Khatwa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "bachelor's degree of physical therapy", 'investigatorFullName': 'Amr Mohsen Mohamed Abo Khatwa', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}