VR-based Remote Rehabilitation for Pediatric ABI

Libra At Home LTD2 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acquired Brain Injury

Interventions

LibraVRDEVICE

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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

ALYN Hospital Pediatric and Adolescent Rehabilitation Center

Jerusalem, Israel

Outcomes

Primary Outcomes

Vestibular Oculomotor Motor Screening (VOMS)

Symptoms scoring from 0 (none) to 10 (severe)

Time frame: 6 months

Pediatric Vestibular Symptom Questionnaire (PVSQ)

Score ranging from 0 (never) to 33 (most of the time) with a 4-Likert scale

Time frame: 6 months

Convergence Insufficiency Symptom Survey (CISS)

Score ranging from 0 (never) to 56 (Always) with a 5-Likert scale

Time frame: 6 months

Dizziness Handicap Inventory (DHI)

Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale

Time frame: 6 months

Dizziness Handicap Inventory for patients caregivers (DHI-PC)

Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale

Time frame: 6 months

Pediatric Quality of Life Inventory (PEDSQL)

Score ranging from 0 (worst) to 100 (best) with a 5-Likert scale

Time frame: 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

Time frame: 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

Time frame: 6 months

Data from ClinicalTrials.gov

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