VR-based Remote Rehabilitation for Pediatric ABI

Study Overview
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Brief Summary
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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

Official Title
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Virtual Reality Based Rehabilitation of Vestibular and Oculomotor Function for Pediatric ABI in a Home Setting

Conditions
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Acquired Brain Injury

Intervention / Treatment
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* Device: LibraVR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study<br>Exercises | Device: LibraVR<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vestibular Oculomotor Motor Screening (VOMS) | Symptoms scoring from 0 (none) to 10 (severe) | 6 months | 
| Pediatric Vestibular Symptom Questionnaire (PVSQ) | Score ranging from 0 (never) to 33 (most of the time) with a 4-Likert scale | 6 months | 
| Convergence Insufficiency Symptom Survey (CISS) | Score ranging from 0 (never) to 56 (Always) with a 5-Likert scale | 6 months | 
| Dizziness Handicap Inventory (DHI) | Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale | 6 months | 
| Dizziness Handicap Inventory for patients caregivers (DHI-PC) | Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale | 6 months | 
| Pediatric Quality of Life Inventory (PEDSQL) | Score ranging from 0 (worst) to 100 (best) with a 5-Likert scale | 6 months | 
| Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) | Time score ranging from 0 (unable to complete) to 120 (completed successfully) in one of three 30-seconds trials and four conditions | 6 months | 
| Berg Balance Scale (Berg) | Score ranging from 0 (lowest level of function) to 56 (highest level of function) with a 5-Likert scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric