VR-based Remote Rehabilitation for Pediatric ABI

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

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 Overview

• Status: Completed
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Device: LibraVR

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • ALYN Hospital Pediatric and Adolescent Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study; Exercises

Device: LibraVR; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Libra At Home LTD
• Collaborators: Alyn Pediatric & Adolescent Rehabilitation Hospital
• Investigators: Principal Investigator: Naomi Gefen, ALYN Hospital Pediatric and Adolescent Rehabilitation Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 12, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 9, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: 041-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No