Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT03386968
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2017-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality and Active Video Games to Improve Balance in Children With Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006429', 'term': 'Hemiplegia'}], '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'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088544', 'term': 'Exergaming'}], 'ancestors': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomized Block Design will be utilized in order to attempt to "match" subjects according to functional level and diagnosis (cerebral palsy or acquired brain injury). Upon signing consent the subjects will be grouped based on their diagnosis. At that time gait speed for the 10 M Walk Test will be utilized to categorize all participants into a "fast" and "slow" group. (subjects performing the 10 M Walk Test at a speed less than .4 m/s will be placed in the "slow" group, and subjects testing at a speed greater than or equal to .4 m/s will be placed in the "fast" group After this determination is made, subjects will be randomized to "control" (usual care), and "intervention" one therapy session replaced with a session utilizing Active video games and the Rutger\'s V-step. A minimum of 2 subjects per grouping will be sought in order to analyze for differences.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-05', 'studyFirstSubmitDate': '2017-12-07', 'studyFirstSubmitQcDate': '2017-12-21', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test', 'timeFrame': 'From before intervention to immediately after intervention', 'description': 'The PEDI-CAT measures abilities in three functional domains: Daily Activities, Mobility and Social/Cognitive.'}], 'secondaryOutcomes': [{'measure': 'Change in 10 Meter walk test', 'timeFrame': 'From before intervention to immediately after intervention', 'description': 'Measures time taken for a participant to walk 10 meters'}, {'measure': 'Change in Gross Motor Function Measure (GMFM) subtest D and E', 'timeFrame': 'From before intervention to immediately after intervention', 'description': 'The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy.'}, {'measure': 'Change in Four Square Step Test', 'timeFrame': 'From before intervention to immediately after intervention', 'description': 'Measures how well a patient can change directions while stepping.'}, {'measure': 'Change in Functional Gait Assessment (FGA)', 'timeFrame': 'From before intervention to immediately after intervention', 'description': '10-item test that assesses dynamic balance and postural stability during gait.'}, {'measure': 'Change in Motor Free Visual Perceptual Test (MVPT)-4', 'timeFrame': 'From before intervention to immediately after intervention', 'description': 'The MVPT-4 assesses five categories of visual perception: Visual Discrimination: Ability to discriminate dominant features of different objects, including the ability to discriminate position, shapes, and forms.'}, {'measure': 'Change in Visually guided weight shift ability as measured by the Smart Balance Master®', 'timeFrame': 'From before intervention to immediately after intervention', 'description': 'Force platform system that tests balance'}, {'measure': "Change in Children's Assessment of Participation and Enjoyment", 'timeFrame': 'From before intervention to immediately after intervention', 'description': "Self-report measures of children's participation in recreation and leisure activities outside of mandated school activities."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'hemiplegia', 'diplegia', 'video gaming', 'active video games', 'Playstation X-Box 360', 'Rutgers V-Step', 'Microsoft Kinect'], 'conditions': ['Cerebral Palsy', 'Acquired Brain Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot feasibility study is to assess the feasibility of using the Playstation Xbox 360 and Rutgers V-step via a Kinect Sensor with active video game software as a part of a physical therapy intervention to improve obstacle negotiation, gait speed, and stair negotiation in ambulatory children with Cerebral Palsy (CP) hemiparesis or spastic diplegia, or non-progressive brain injury (BI). Children will be assessed using perceptual, balance, functional and gait assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 7-17\n* Diagnosis of Cerebral Palsy or Diagnosis of Acquired Brain Injury\n* Ambulatory with or without an assistive device x 150 feet\n* Cognition and attention ability sufficient to be successful in video game play and to follow instructions of the investigator.\n* Able to complete testing process.\n* Current patient at Blythedale Children's Hospital program (Expected Length of Stay/availability for study of approximately 8 weeks)\n\nExclusion Criteria:\n\n* Any history of photosensitive epilepsy or seizures triggered by exposure to flashing lights, television or video games\n* Attention or behavior problems that prevent the successful completion of game play\n* Any acute musculoskeletal injury that limits weight bearing on one lower extremity (due to orthopedist concerns for fracture or injury)\n* Any medical condition that prevents the child from tolerating exercise due to cardiovascular conditions"}, 'identificationModule': {'nctId': 'NCT03386968', 'briefTitle': 'Virtual Reality and Active Video Games to Improve Balance in Children With Brain Injury', 'organization': {'class': 'OTHER', 'fullName': "Blythedale Children's Hospital"}, 'officialTitle': 'Use of Low-Cost Virtual Reality and Active Video Games to Improve Balance and Perceptual Skills in Children With Cerebral Palsy and Brain Injury', 'orgStudyIdInfo': {'id': '17-1206TS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video gaming', 'description': "A child's usual physical therapy session will be replaced with a session utilizing Active video games and the Rutger's V-step.", 'interventionNames': ['Behavioral: Active video gaming']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Children will receive their usual care in the physical therapy program at Blythedale.', 'interventionNames': ['Behavioral: Usual care physical therapy']}], 'interventions': [{'name': 'Active video gaming', 'type': 'BEHAVIORAL', 'description': 'Children will visit Blythedale for 8 sessions, one 45-session visit per week, in place of one of the child\'s typical physical therapy sessions. During each session, children will play a video game on the X-Box Kinect system, using the games "Kinect Adventures" and "Kinect Sports". The child will first play a "Kinect Adventures" game, which requires ambulating, ducking, and dodging one\'s way through an obstacle course.', 'armGroupLabels': ['Video gaming']}, {'name': 'Usual care physical therapy', 'type': 'BEHAVIORAL', 'description': 'Children will attend their usual care physical therapy appointments at Blythedale.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': "Blythedale Children's Hospital", 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Blythedale Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}