Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury

Study Overview
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Brief Summary
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The aim of this research program is to 1) Evaluate potential problems with vision, inner ear-eye reflexes and deficits of processing eye information that occur following TBI; and 2) Evaluate treatment programs for individuals with eye and inner ear problems that persist for greater than 10 days following injury. This study will include 465 youth and young adults (aged 6-30 years old) who sustain a TBI of any severity. An initial evaluative phase using the best available technology to evaluate eye and inner ear function will be performed, and compared with typical tests that are used in the clinic. If symptoms and functional problems remain 10 days after injury, participants will be randomly placed into a treatment group (including eye movement, inner ear-eye reflex and attention exercises as per our pilot studies) or a control group (typical rehabilitation). Success will be measured in terms of return to sport (mild TBI), achievement of goals (moderate and severe TBI) and quality of life. It is expected that this program will inform clinical practice and future research leading to a treatment program in TBI that includes multiple components.

Official Title
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Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury

Conditions
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Mild Traumatic Brain Injury; Concussion

Intervention / Treatment
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* Other: Vestibular-Visual Intervention
* Behavioral: standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild TBI or moderate-severe TBI will be included Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The intervention will be an individualized impairment-based program based on a pre-determined sequence. A minimal intervention for all participants randomized to the intervention group at all sites will include general oculomotor and gaze stabilization retraining as tolerated. Intervention activities will be recorded and described in detail in a treatment log. | Other: Vestibular-Visual Intervention<br>* vestibular-visual exercises<br>|
| Active Comparator: Control<br>Standard care for mild TBI consists mainly of general education, energy conservation, academic adaptations, and restricting children and adolescents from participation in vigorous physical activities as well as complex cognitive activities until complete symptom resolution. It is the usual approach promoted by various associations and consensus groups. In addition, in all participating centers, children and teens requiring musculoskeletal approaches to address neck pain/dysfunction will receive it as indicated, based on the clinical judgment of the local team. Participants with moderate and severe TBI will also receive rehabilitation activities as planned in their respective centers. The standard care intervention will be recorded and described in detail in a treatment log. | Behavioral: standard care<br>* standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PedsQL | Pediatric and adult Quality of Life | 8 weeks post intervention initiation | 
| Head Thrust Test | Vestibulo-Ocular Reflex | 8 weeks post-intervention initiation |