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Clinical Trials/NCT05052905
NCT05052905
Completed
N/A

Virtual Reality Based Rehabilitation of Vestibular and Oculomotor Function for Pediatric ABI in a Home Setting

Libra At Home LTD1 site in 1 country2 target enrollmentOctober 15, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acquired Brain Injury
Sponsor
Libra At Home LTD
Enrollment
2
Locations
1
Primary Endpoint
Pediatric Vestibular Symptom Questionnaire (PVSQ)
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 15, 2021
End Date
April 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Libra At Home LTD
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Vestibular Oculomotor Motor Screening (VOMS)

Time Frame: 6 months

Symptoms scoring from 0 (none) to 10 (severe)

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 for patients caregivers (DHI-PC)

Time Frame: 6 months

Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale

Dizziness Handicap Inventory (DHI)

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

Study Sites (1)

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