Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury (SiMPlyRehab)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03215082|
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : April 5, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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
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
- PedsQL [ Time Frame: 8 weeks post intervention initiation ]Pediatric and adult Quality of Life
- Head Thrust Test [ Time Frame: 8 weeks post-intervention initiation ]Vestibulo-Ocular Reflex
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
|Contact: Isabelle Gagnon, PhD||514-412-4400 ext 23896||Isabelle.firstname.lastname@example.org|
|Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary,||Recruiting|
|Calgary, Alberta, Canada, T2N 1N4|
|Contact: Kathryn Schneider, PhD 403-210-8951 email@example.com|
|Montreal Children's Hospital, MUHC||Recruiting|
|Montreal, Quebec, Canada, H4A3J1|
|Contact: Isabelle Gagnon, PhD 514-412-4400 ext 23896 firstname.lastname@example.org|
|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 email@example.com|
|Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine||Recruiting|
|Tel Aviv, Israel|
|Contact: Michal Katz-Leurer, PhD 97236405432 firstname.lastname@example.org|