VR-based Remote Rehabilitation for Pediatric ABI

NCT05052905 | Completed

• 1 other identifier: 041-21
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Acquired Brain Injury

Keywords

Pediatric

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Study

EXPERIMENTAL

Exercises

Device: LibraVR

Interventions

LibraVR DEVICE

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.

Study

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Libra At Home LTD: lead
• Alyn Pediatric & Adolescent Rehabilitation Hospital: collaborator

Study Sites (1)

ALYN Hospital Pediatric and Adolescent Rehabilitation Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Naomi Gefen

  ALYN Hospital Pediatric and Adolescent Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 22, 2021
• Study Start: October 15, 2021
• Primary Completion: December 15, 2022
• Study Completion: April 1, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)