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

Mild Traumatic Brain Injury; Concussion Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03215082
• Other study ID #: 2018-3373
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: McGill University Health Center
• Contact: Isabelle Gagnon, PhD
• Phone: 514-412-4400
• Email: Isabelle.gagnon8[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 50 Years

Eligibility

Inclusion Criteria:

• Mild TBI or moderate-severe TBI will be included

Exclusion Criteria:

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury; Concussion
• Wounds and Injuries

Intervention

Other:
• Vestibular-Visual Intervention
vestibular-visual exercises

Behavioral:
• standard care
standard care

Locations

Country	Name	City	State
Canada	Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary,	Calgary	Alberta
Canada	Montreal Children's Hospital, MUHC	Montreal	Quebec
France	Service de Rééducation des Pathologies Neurologiques de l'Enfant - Pôle de Rééducation et Réadaptation de l'Enfant Hôpitaux de Saint Maurice	Saint-Maurice
Israel	Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Countries where clinical trial is conducted

Canada,  France,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PedsQL	Pediatric and adult Quality of Life	8 weeks post intervention initiation
Primary	Head Thrust Test	Vestibulo-Ocular Reflex	8 weeks post-intervention initiation