VR-based Remote Rehabilitation for Pediatric ABI
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
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Outcome Measures
Primary Outcome Measures
- Vestibular Oculomotor Motor Screening (VOMS) [6 months]
Symptoms scoring from 0 (none) to 10 (severe)
- Pediatric Vestibular Symptom Questionnaire (PVSQ) [6 months]
Score ranging from 0 (never) to 33 (most of the time) with a 4-Likert scale
- Convergence Insufficiency Symptom Survey (CISS) [6 months]
Score ranging from 0 (never) to 56 (Always) with a 5-Likert scale
- Dizziness Handicap Inventory (DHI) [6 months]
Score ranging from 0 (none) to 100 (severe) with a 3-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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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They are ALYN patients undergoing physiotherapy for mild to severe ABI;
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They experience symptoms of vestibular function such as vertigo, postural instability, or impaired ocular motility;
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They are between the ages of 8 and 18;
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The time since injury/event is between 10 days and 1 year after the injury/event;
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They are able to maintain stable and dynamic positioning of the head;
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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);
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Are able to understand basic instructions;
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Have sufficient visual acuity and visual field to identify and track mid-size objects on a screen.
Exclusion Criteria:
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Psychological, neurological or cognitive disorders which could impede participation, such as a history of epileptic seizures;
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Untreated benign paroxysmal positional vertigo (BPPV);
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Are in early post-operative stages (to avoid risk of bleeding or cerebrospinal fluid leak);
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Hearing impairment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ALYN Hospital Pediatric and Adolescent Rehabilitation Center | Jerusalem | Israel |
Sponsors and Collaborators
- Libra At Home LTD
- Alyn Pediatric & Adolescent Rehabilitation Hospital
Investigators
- Principal Investigator: Naomi Gefen, ALYN Hospital Pediatric and Adolescent Rehabilitation Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 041-21