Recruiting

Observational Study

Sponsor:

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

Code:

NCT03215082

Conditions

Mild Traumatic Brain Injury; Concussion

Eligibility Criteria

Sex: All

Age: 6 - 50

Healthy Volunteers: Accepted

Interventions

Vestibular-Visual Intervention

standard care

Study Details

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.

Conditions

Mild Traumatic Brain Injury; Concussion

Study ID

NCT03215082

Start date

Jan 1, 2018

Status verified date

Apr, 2019

Completion date

Dec, 2020

Anticipated

Primary completion date

Oct, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Mild TBI or moderate-severe TBI will be included

Exclusion Criteria:

-

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental

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.

active comparator: Control

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.

Interventions

Vestibular-Visual Intervention

vestibular-visual exercises

standard care

standard care

Primary outcome measure

  • PedsQL [ Time Frame: 8 weeks post intervention initiation ]
  • Head Thrust Test [ Time Frame: 8 weeks post-intervention initiation ]

Central Contacts and Locations

Central contacts

Isabelle Gagnon, PhD

514-412-4400Isabelle.gagnon8@mcgill.ca

Locations

Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary,

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Kathryn Schneider, PhD

403-210-8951kjschnei@ucalgary.ca

Montreal Children's Hospital, MUHC

Recruiting

Montreal, Quebec, Canada, H4A3J1

Contacts

Isabelle Gagnon, PhD

514-412-4400isabelle.gagnon8@mcgill.ca

More Information

Sponsor

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

Last update posted

Apr 5, 2019

Last verified

Apr, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2019-04-05.