VR-based Remote Rehabilitation for Pediatric ABI

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052905
• Other study ID #: 041-21
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: December 2023
• Source: Libra At Home LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 1, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries

Intervention

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.

Locations

Country	Name	City	State
Israel	ALYN Hospital Pediatric and Adolescent Rehabilitation Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Libra At Home LTD	Alyn Pediatric & Adolescent Rehabilitation Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vestibular Oculomotor Motor Screening (VOMS)	Symptoms scoring from 0 (none) to 10 (severe)	6 months
Primary	Pediatric Vestibular Symptom Questionnaire (PVSQ)	Score ranging from 0 (never) to 33 (most of the time) with a 4-Likert scale	6 months
Primary	Convergence Insufficiency Symptom Survey (CISS)	Score ranging from 0 (never) to 56 (Always) with a 5-Likert scale	6 months
Primary	Dizziness Handicap Inventory (DHI)	Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale	6 months
Primary	Dizziness Handicap Inventory for patients caregivers (DHI-PC)	Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale	6 months
Primary	Pediatric Quality of Life Inventory (PEDSQL)	Score ranging from 0 (worst) to 100 (best) with a 5-Likert scale	6 months
Primary	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
Primary	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