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VR-based Remote Rehabilitation for Pediatric ABI

NCT ID: NCT05052905

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2023-04-01

Brief Summary

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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

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Conditions

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Acquired Brain Injury

Keywords

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Pediatric

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study

Exercises

Group Type EXPERIMENTAL

LibraVR

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alyn Pediatric & Adolescent Rehabilitation Hospital

OTHER

Sponsor Role collaborator

Libra At Home LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naomi Gefen

Role: PRINCIPAL_INVESTIGATOR

ALYN Hospital Pediatric and Adolescent Rehabilitation Center

Locations

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ALYN Hospital Pediatric and Adolescent Rehabilitation Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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041-21

Identifier Type: -

Identifier Source: org_study_id