VR-based Remote Rehabilitation for Pediatric ABI

Not Applicable

Completed

• Conditions: Acquired Brain Injury
• Interventions: Device: LibraVR

• Registration Number: NCT05052905
• Lead Sponsor: Libra At Home LTD

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-09-12
• Study First Posted: 2021-09-22
• Study Start: 2021-10-15
• Primary Completion: 2022-12-15
• Study Completion: 2023-04-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-09
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study	LibraVR	Exercises

Primary Outcome Measures

Name	Time	Method
Pediatric Vestibular Symptom Questionnaire (PVSQ)	6 months	Score ranging from 0 (never) to 33 (most of the time) with a 4-Likert scale
Vestibular Oculomotor Motor Screening (VOMS)	6 months	Symptoms scoring from 0 (none) to 10 (severe)
Convergence Insufficiency Symptom Survey (CISS)	6 months	Score ranging from 0 (never) to 56 (Always) with a 5-Likert scale
Dizziness Handicap Inventory for patients caregivers (DHI-PC)	6 months	Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale
Dizziness Handicap Inventory (DHI)	6 months	Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale
Pediatric Quality of Life Inventory (PEDSQL)	6 months	Score ranging from 0 (worst) to 100 (best) with a 5-Likert scale
Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)	6 months	Time score ranging from 0 (unable to complete) to 120 (completed successfully) in one of three 30-seconds trials and four conditions
Berg Balance Scale (Berg)	6 months	Score ranging from 0 (lowest level of function) to 56 (highest level of function) with a 5-Likert scale

Trial Locations

Locations (1)

ALYN Hospital Pediatric and Adolescent Rehabilitation Center; 🇮🇱 Jerusalem, Israel