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

Not Applicable

• Conditions: Mild Traumatic Brain Injury; Concussion

• Registration Number: NCT03215082
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Study Start: 2018-01-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05
• Primary Completion: 2020-10
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Mild TBI or moderate-severe TBI will be included

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PedsQL	8 weeks post intervention initiation	Pediatric and adult Quality of Life
Head Thrust Test	8 weeks post-intervention initiation	Vestibulo-Ocular Reflex

Trial Locations

Locations (4)

Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary,; 🇨🇦 Calgary, Alberta, Canada

Montreal Children's Hospital, MUHC; 🇨🇦 Montreal, Quebec, Canada

Service de Rééducation des Pathologies Neurologiques de l'Enfant - Pôle de Rééducation et Réadaptation de l'Enfant Hôpitaux de Saint Maurice; 🇫🇷 Saint-Maurice, France

Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine; 🇮🇱 Tel Aviv, Israel