Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-01-02 @ 2:41 AM
Study NCT ID:
NCT05464004
Status:
COMPLETED
Last Update Posted:
2022-07-19
First Post:
2022-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Nintendo Wii Balance Board in Children With Cerebral Palsy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Effects of Nintendo Wii balance board in combination with conventional physical therapy in children with CP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2022-07-14', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of Nintendo Wii balance board in children with CP', 'timeFrame': '8th week', 'description': 'Changes from the baseline. it was designed to measure the balance issues in children with pediatric balance scale and pediatric forward reach test. it consist of 14 items and total score of 56'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Balance Problem', 'Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '17370477', 'type': 'BACKGROUND', 'citation': 'Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.'}, {'pmid': '11727367', 'type': 'BACKGROUND', 'citation': 'Gage JR, Novacheck TF. An update on the treatment of gait problems in cerebral palsy. J Pediatr Orthop B. 2001 Oct;10(4):265-74.'}, {'pmid': '16097489', 'type': 'BACKGROUND', 'citation': 'Woollacott MH, Shumway-Cook A. Postural dysfunction during standing and walking in children with cerebral palsy: what are the underlying problems and what new therapies might improve balance? Neural Plast. 2005;12(2-3):211-9; discussion 263-72. doi: 10.1155/NP.2005.211.'}, {'pmid': '32086598', 'type': 'BACKGROUND', 'citation': 'Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.'}]}, 'descriptionModule': {'briefSummary': 'I wan to check the effects of Nintendo Wii balance board therapy in children with CP.', 'detailedDescription': 'Evaluate the effects of Nintendo Wii balance board therapy in combination with conventional physical therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children with age of 7-14 years. No history of falls. children able to stand independently. delays in gait development.\n\nExclusion Criteria:\n\n* Children with hemiplegic CP. Comorbidities. children with lower limb contractures. hearing disorders. children with epilepsy.'}, 'identificationModule': {'nctId': 'NCT05464004', 'briefTitle': 'Effects of Nintendo Wii Balance Board in Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Nintendo Wii Balance Board in Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'REC/RCR & AHS/22/0706'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional physical therapy', 'description': 'stretching, strengthening and balance exercises', 'interventionNames': ['Other: Nintendo Wii balance board']}, {'type': 'EXPERIMENTAL', 'label': 'Nintendo Wii balance board therapy', 'description': 'Nintendo Wii balance board therapy in combination with conventional physical therapy', 'interventionNames': ['Other: Nintendo Wii balance board']}], 'interventions': [{'name': 'Nintendo Wii balance board', 'type': 'OTHER', 'otherNames': ['Conventional physical therapy'], 'description': 'Experimental group was given Nintendo Wii balance board therapy in combination with conventional physical therapy for 16 sessions/8 weeks\n\nControl group was conventional physical therapy which include stretching of the hamstrings, quadriceps and calf muscles. strengthening of the lower limb. Balance exercises include walk in parallel bar', 'armGroupLabels': ['Nintendo Wii balance board therapy', 'conventional physical therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40050', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Rising Sun Institute', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Wajiha Shahid, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}