Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT05052905
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2021-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VR-based Remote Rehabilitation for Pediatric ABI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-09', 'studyFirstSubmitDate': '2021-08-25', 'studyFirstSubmitQcDate': '2021-09-12', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vestibular Oculomotor Motor Screening (VOMS)', 'timeFrame': '6 months', 'description': 'Symptoms scoring from 0 (none) to 10 (severe)'}, {'measure': 'Pediatric Vestibular Symptom Questionnaire (PVSQ)', 'timeFrame': '6 months', 'description': 'Score ranging from 0 (never) to 33 (most of the time) with a 4-Likert scale'}, {'measure': 'Convergence Insufficiency Symptom Survey (CISS)', 'timeFrame': '6 months', 'description': 'Score ranging from 0 (never) to 56 (Always) with a 5-Likert scale'}, {'measure': 'Dizziness Handicap Inventory (DHI)', 'timeFrame': '6 months', 'description': 'Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale'}, {'measure': 'Dizziness Handicap Inventory for patients caregivers (DHI-PC)', 'timeFrame': '6 months', 'description': 'Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale'}, {'measure': 'Pediatric Quality of Life Inventory (PEDSQL)', 'timeFrame': '6 months', 'description': 'Score ranging from 0 (worst) to 100 (best) with a 5-Likert scale'}, {'measure': 'Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)', 'timeFrame': '6 months', 'description': 'Time score ranging from 0 (unable to complete) to 120 (completed successfully) in one of three 30-seconds trials and four conditions'}, {'measure': 'Berg Balance Scale (Berg)', 'timeFrame': '6 months', 'description': 'Score ranging from 0 (lowest level of function) to 56 (highest level of function) with a 5-Likert scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric'], 'conditions': ['Acquired Brain Injury']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the feasibility and effectiveness of an at-home program of VR-based vestibular and oculomotor rehabilitation on improving postural stability, ocular motility and activities of daily living for children with mild to severe ABI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* They are ALYN patients undergoing physiotherapy for mild to severe ABI;\n* They experience symptoms of vestibular function such as vertigo, postural instability, or impaired ocular motility;\n* They are between the ages of 8 and 18;\n* The time since injury/event is between 10 days and 1 year after the injury/event;\n* They are able to maintain stable and dynamic positioning of the head;\n* They able to walk with or without assistive equipment, or use a wheelchairs with no need for head support, defined by a LSS (level of sitting scale) score of 3 or greater (scale range: 1-8);\n* Are able to understand basic instructions;\n* Have sufficient visual acuity and visual field to identify and track mid-size objects on a screen.\n\nExclusion Criteria:\n\n* Psychological, neurological or cognitive disorders which could impede participation, such as a history of epileptic seizures;\n* Untreated benign paroxysmal positional vertigo (BPPV);\n* Are in early post-operative stages (to avoid risk of bleeding or cerebrospinal fluid leak);\n* Hearing impairment.'}, 'identificationModule': {'nctId': 'NCT05052905', 'briefTitle': 'VR-based Remote Rehabilitation for Pediatric ABI', 'organization': {'class': 'INDUSTRY', 'fullName': 'Libra At Home LTD'}, 'officialTitle': 'Virtual Reality Based Rehabilitation of Vestibular and Oculomotor Function for Pediatric ABI in a Home Setting', 'orgStudyIdInfo': {'id': '041-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study', 'description': 'Exercises', 'interventionNames': ['Device: LibraVR']}], 'interventions': [{'name': 'LibraVR', 'type': 'DEVICE', 'description': 'LibraVR is a standalone VR-based rehabilitation software for use in physiotherapy. It is designed to work with standard off-the-shelf hardware that is tested and approved for use in conjunction with the software.\n\nLibraVR system consists of the software (LibraVR Clinic) running on a PC (database of patients, creation of protocols, uploading protocols to mobile), and the LibraVR Mobile APP that runs on commercial mobile smartphones embedded in a lightweight cardboard or plastic VR viewer that the child wears as they would eyeglasses. The software displays a range of immersive VR exercises.', 'armGroupLabels': ['Study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'ALYN Hospital Pediatric and Adolescent Rehabilitation Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Naomi Gefen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ALYN Hospital Pediatric and Adolescent Rehabilitation Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Libra At Home LTD', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Alyn Pediatric & Adolescent Rehabilitation Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}