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OpenTrials
Completed

NCT Number: NCT05052905

VR-based Remote Rehabilitation for Pediatric ABI

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

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Key information

Conditions

Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ALYN Hospital Pediatric and Adolescent Rehabilitation Center

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Vestibular Oculomotor Motor Screening (VOMS)

    Time frame: 6 months

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

  2. Pediatric Vestibular Symptom Questionnaire (PVSQ)

    Time frame: 6 months

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

  3. Convergence Insufficiency Symptom Survey (CISS)

    Time frame: 6 months

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

  4. Dizziness Handicap Inventory (DHI)

    Time frame: 6 months

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

  5. Dizziness Handicap Inventory for patients caregivers (DHI-PC)

    Time frame: 6 months

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

  6. Pediatric Quality of Life Inventory (PEDSQL)

    Time frame: 6 months

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

  7. Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)

    Time frame: 6 months

    Time score ranging from 0 (unable to complete) to 120 (completed successfully) in one of three 30-seconds trials and four conditions

  8. Berg Balance Scale (Berg)

    Time frame: 6 months

    Score ranging from 0 (lowest level of function) to 56 (highest level of function) with a 5-Likert scale

Sponsors and collaborators

Lead sponsor

Libra At Home LTD

Industry

Collaborators

  • Alyn Pediatric & Adolescent Rehabilitation Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 22, 2021
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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