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Clinical Trials/NCT03215082
NCT03215082
Unknown
Not Applicable

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

McGill University Health Centre/Research Institute of the McGill University Health Centre4 sites in 3 countries400 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Traumatic Brain Injury; Concussion
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
400
Locations
4
Primary Endpoint
PedsQL
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Isabelle Gagnon

Clinical Scientist

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

Inclusion Criteria

  • Mild TBI or moderate-severe TBI will be included

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

PedsQL

Time Frame: 8 weeks post intervention initiation

Pediatric and adult Quality of Life

Head Thrust Test

Time Frame: 8 weeks post-intervention initiation

Vestibulo-Ocular Reflex

Study Sites (4)

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