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

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ClinicalTrials.gov Identifier: NCT03215082
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Isabelle Gagnon, McGill University Health Center

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.


Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury; Concussion Other: Vestibular-Visual Intervention Behavioral: standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Vestibular-Visual Intervention
vestibular-visual exercises

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.
Behavioral: standard care
standard care




Primary Outcome Measures :
  1. PedsQL [ Time Frame: 8 weeks post intervention initiation ]
    Pediatric and adult Quality of Life

  2. Head Thrust Test [ Time Frame: 8 weeks post-intervention initiation ]
    Vestibulo-Ocular Reflex



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mild TBI or moderate-severe TBI will be included

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215082


Contacts
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Contact: Isabelle Gagnon, PhD 514-412-4400 ext 23896 Isabelle.gagnon8@mcgill.ca

Locations
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Canada, Alberta
Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Kathryn Schneider, PhD    403-210-8951    kjschnei@ucalgary.ca   
Canada, Quebec
Montreal Children's Hospital, MUHC Recruiting
Montreal, Quebec, Canada, H4A3J1
Contact: Isabelle Gagnon, PhD    514-412-4400 ext 23896    isabelle.gagnon8@mcgill.ca   
France
Service de Rééducation des Pathologies Neurologiques de l'Enfant - Pôle de Rééducation et Réadaptation de l'Enfant Hôpitaux de Saint Maurice Recruiting
Saint-Maurice, France, 94410
Contact: Mathilde Chevignard, PhD    01 43 96 63 40    m.chevignard@hopitaux-stmaurice.fr   
Israel
Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine Recruiting
Tel Aviv, Israel
Contact: Michal Katz-Leurer, PhD    97236405432    michalkz@post.tau.ac.il   
Sponsors and Collaborators
McGill University Health Center

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Responsible Party: Isabelle Gagnon, Clinical Scientist, McGill University Health Center
ClinicalTrials.gov Identifier: NCT03215082     History of Changes
Other Study ID Numbers: 2018-3373
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating