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

McGill University

Status: Unknown

Conditions: Mild Traumatic Brain Injury; Concussion

Treatments: Behavioral: standard care; Other: Vestibular-Visual Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03215082

2018-3373

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 6 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Mild TBI or moderate-severe TBI will be included

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

Experimental

Experimental group

Description:

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.

Treatment:

Other: Vestibular-Visual Intervention

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: standard care