Back to resultsVR-based Remote Rehabilitation for Pediatric ABI
Primary Purpose
Acquired Brain Injury
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
LibraVR
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Brain Injury focused on measuring Pediatric
Eligibility Criteria
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.
Sites / Locations
- ALYN Hospital Pediatric and Adolescent Rehabilitation Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study
Arm Description
Exercises
Outcomes
Primary Outcome Measures
Vestibular Oculomotor Motor Screening (VOMS)
Symptoms scoring from 0 (none) to 10 (severe)
Pediatric Vestibular Symptom Questionnaire (PVSQ)
Score ranging from 0 (never) to 33 (most of the time) with a 4-Likert scale
Convergence Insufficiency Symptom Survey (CISS)
Score ranging from 0 (never) to 56 (Always) with a 5-Likert scale
Dizziness Handicap Inventory (DHI)
Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale
Dizziness Handicap Inventory for patients caregivers (DHI-PC)
Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale
Pediatric Quality of Life Inventory (PEDSQL)
Score ranging from 0 (worst) to 100 (best) with a 5-Likert scale
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
Berg Balance Scale (Berg)
Score ranging from 0 (lowest level of function) to 56 (highest level of function) with a 5-Likert scale
Secondary Outcome Measures
Full Information
NCT ID
NCT05052905
First Posted
August 25, 2021
Last Updated
August 15, 2022
Sponsor
Libra At Home LTD
Collaborators
Alyn Pediatric & Adolescent Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05052905
Brief Title
VR-based Remote Rehabilitation for Pediatric ABI
Official Title
Virtual Reality Based Rehabilitation of Vestibular and Oculomotor Function for Pediatric ABI in a Home Setting
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Libra At Home LTD
Collaborators
Alyn Pediatric & Adolescent Rehabilitation Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury
Keywords
Pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study
Arm Type
Experimental
Arm Description
Exercises
Intervention Type
Device
Intervention Name(s)
LibraVR
Intervention Description
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 Outcome Measure Information:
Title
Vestibular Oculomotor Motor Screening (VOMS)
Description
Symptoms scoring from 0 (none) to 10 (severe)
Time Frame
6 months
Title
Pediatric Vestibular Symptom Questionnaire (PVSQ)
Description
Score ranging from 0 (never) to 33 (most of the time) with a 4-Likert scale
Time Frame
6 months
Title
Convergence Insufficiency Symptom Survey (CISS)
Description
Score ranging from 0 (never) to 56 (Always) with a 5-Likert scale
Time Frame
6 months
Title
Dizziness Handicap Inventory (DHI)
Description
Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale
Time Frame
6 months
Title
Dizziness Handicap Inventory for patients caregivers (DHI-PC)
Description
Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale
Time Frame
6 months
Title
Pediatric Quality of Life Inventory (PEDSQL)
Description
Score ranging from 0 (worst) to 100 (best) with a 5-Likert scale
Time Frame
6 months
Title
Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)
Description
Time score ranging from 0 (unable to complete) to 120 (completed successfully) in one of three 30-seconds trials and four conditions
Time Frame
6 months
Title
Berg Balance Scale (Berg)
Description
Score ranging from 0 (lowest level of function) to 56 (highest level of function) with a 5-Likert scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Gefen
Organizational Affiliation
ALYN Hospital Pediatric and Adolescent Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
ALYN Hospital Pediatric and Adolescent Rehabilitation Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
VR-based Remote Rehabilitation for Pediatric ABI
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