Acquired Brain Injury
Conditions
Keywords
Pediatric
Brief summary
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
Interventions
DEVICELibraVR
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. LibraVR 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.
Sponsors
Alyn Pediatric & Adolescent Rehabilitation Hospital
Libra At Home LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* They are ALYN patients undergoing physiotherapy for mild to severe ABI; * They experience symptoms of vestibular function such as vertigo, postural instability, or impaired ocular motility; * They are between the ages of 8 and 18; * The time since injury/event is between 10 days and 1 year after the injury/event; * They are able to maintain stable and dynamic positioning of the head; * 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); * Are able to understand basic instructions; * Have sufficient visual acuity and visual field to identify and track mid-size objects on a screen.
Exclusion criteria
* Psychological, neurological or cognitive disorders which could impede participation, such as a history of epileptic seizures; * Untreated benign paroxysmal positional vertigo (BPPV); * Are in early post-operative stages (to avoid risk of bleeding or cerebrospinal fluid leak); * Hearing impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vestibular Oculomotor Motor Screening (VOMS) | 6 months | Symptoms scoring from 0 (none) to 10 (severe) |
| Pediatric Vestibular Symptom Questionnaire (PVSQ) | 6 months | Score ranging from 0 (never) to 33 (most of the time) with a 4-Likert scale |
| Convergence Insufficiency Symptom Survey (CISS) | 6 months | Score ranging from 0 (never) to 56 (Always) with a 5-Likert scale |
| Dizziness Handicap Inventory (DHI) | 6 months | Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale |
| Dizziness Handicap Inventory for patients caregivers (DHI-PC) | 6 months | Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale |
| Pediatric Quality of Life Inventory (PEDSQL) | 6 months | Score ranging from 0 (worst) to 100 (best) with a 5-Likert scale |
| Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) | 6 months | Time score ranging from 0 (unable to complete) to 120 (completed successfully) in one of three 30-seconds trials and four conditions |
| Berg Balance Scale (Berg) | 6 months | Score ranging from 0 (lowest level of function) to 56 (highest level of function) with a 5-Likert scale |
Countries
Israel
Outcome results
None listed