Clinical trial NCT03215082: Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury
Official title: Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Traumatic Brain Injury; Concussion
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Mild TBI or moderate-severe TBI will be included

Exclusion Criteria:

-

Primary outcomes:
measure: PedsQL
timeFrame: 8 weeks post intervention initiation
measure: Head Thrust Test
timeFrame: 8 weeks post-intervention initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary,
state: Alberta
city: Montreal
country: Canada
facility: Montreal Children's Hospital, MUHC
state: Quebec
city: Saint-Maurice
country: France
facility: Service de Rééducation des Pathologies Neurologiques de l'Enfant - Pôle de Rééducation et Réadaptation de l'Enfant Hôpitaux de Saint Maurice
city: Tel Aviv
country: Israel
facility: Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine
Study officials:
References:
citation: Sorek G, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Shaklai S, Katz-Leurer M. The Cardiac Autonomic Response Recovery to the Modified Tilt Test in Children Post Moderate-Severe Traumatic Brain Injury. Brain Inj. 2022 Jul 3;36(8):1033-1038. doi: 10.1080/02699052.2022.2110942. Epub 2022 Aug 15.
citation: Sorek G, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Shaklai S, Katz-Leurer M. The integrated functions of the cardiac autonomic and vestibular/oculomotor systems in adolescents following severe traumatic brain injury and typically developing controls. Brain Inj. 2020 Sep 18;34(11):1480-1488. doi: 10.1080/02699052.2020.1807055. Epub 2020 Aug 18.