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Experimental for Concussion (SiMPlyRehab Trial)

N/A
Waitlist Available
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Mild TBI or moderate-severe TBI will be included
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks post-intervention initiation
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Concussion

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks post intervention initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks post intervention initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Head Thrust Test
PedsQL

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
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.

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Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
470 Previous Clinical Trials
166,561 Total Patients Enrolled
~51 spots leftby Nov 2025