Acquired Brain InjuryNCT05052905
VR-based Remote Rehabilitation for Pediatric ABI
A study testing LibraVR in people with Acquired Brain Injury, run by Libra At Home LTD at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- LibraVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Oct 2021to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
ALYN Hospital Pediatric and Adolescent Rehabilitation Center
Jerusalem
About this study
Official title: Virtual Reality Based Rehabilitation of Vestibular and Oculomotor Function for Pediatric ABI in a Home Setting
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
- Conditions
- Acquired Brain Injury
- Being tested
- LibraVR
- Keywords
- Pediatric
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LibraVRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Exercises Receives: Device: LibraVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular Oculomotor Motor Screening (VOMS)
Symptoms scoring from 0 (none) to 10 (severe)
Measured: 6 months
Pediatric Vestibular Symptom Questionnaire (PVSQ)
Score ranging from 0 (never) to 33 (most of the time) with a 4-Likert scale
Measured: 6 months
Convergence Insufficiency Symptom Survey (CISS)
Score ranging from 0 (never) to 56 (Always) with a 5-Likert scale
Measured: 6 months
Dizziness Handicap Inventory (DHI)
Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale
Measured: 6 months
Dizziness Handicap Inventory for patients caregivers (DHI-PC)
Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale
Measured: 6 months
Pediatric Quality of Life Inventory (PEDSQL)
Score ranging from 0 (worst) to 100 (best) with a 5-Likert scale
Measured: 6 months
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
Measured: 6 months
Berg Balance Scale (Berg)
Score ranging from 0 (lowest level of function) to 56 (highest level of function) with a 5-Likert scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start15 Oct 2021
- Primary completion15 Dec 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Libra At Home LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alyn Pediatric & Adolescent Rehabilitation Hospital
- Responsible party
- Sponsor
- Investigators
- Naomi Gefen, Principal investigator, ALYN Hospital Pediatric and Adolescent Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052905
- Sponsor's protocol ID
- 041-21
- Status last verified
- Dec 2023
- First submitted
- 25 Aug 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Based Rehabilitation of Vestibular and Oculomotor Function for Pediatric ABI in a Home Setting
- ClinicalTrials.gov ID
- NCT05052905
- Acronym / sponsor ID
- 041-21
- Conditions
- Acquired Brain Injury
- Keywords
- Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Libra At Home LTDIndustry (pharma, biotech, devices)
- Collaborators
- Alyn Pediatric & Adolescent Rehabilitation Hospital
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Device: LibraVRExercises |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LibraVRLibraVR 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. | Device | Study |
Primary outcome
Vestibular Oculomotor Motor Screening (VOMS)
Time frame: 6 months
Symptoms scoring from 0 (none) to 10 (severe)
Pediatric Vestibular Symptom Questionnaire (PVSQ)
Time frame: 6 months
Score ranging from 0 (never) to 33 (most of the time) with a 4-Likert scale
Convergence Insufficiency Symptom Survey (CISS)
Time frame: 6 months
Score ranging from 0 (never) to 56 (Always) with a 5-Likert scale
Dizziness Handicap Inventory (DHI)
Time frame: 6 months
Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale
Dizziness Handicap Inventory for patients caregivers (DHI-PC)
Time frame: 6 months
Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale
Pediatric Quality of Life Inventory (PEDSQL)
Time frame: 6 months
Score ranging from 0 (worst) to 100 (best) with a 5-Likert scale
Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)
Time frame: 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)
Time frame: 6 months
Score ranging from 0 (lowest level of function) to 56 (highest level of function) with a 5-Likert scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Gefen principal investigator
ALYN Hospital Pediatric and Adolescent Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LibraVR in people with Acquired Brain Injury, run by Libra At Home LTD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular Oculomotor Motor Screening (VOMS) (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023; AzTrials last refreshed its copy on 26 Oct 2026.