Subsymptom Threshold Exercise Protocol Following Mild TBI

Study Overview
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Brief Summary
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The study will monitor outcomes of two interventions to develop a best practice in the treatment of mild Traumatic Brain Injury (mTBI).

Detailed Description
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The proposed pilot randomized controlled clinical trial (RCCT) will provide preliminary data to examine the effect of a novel intervention to promote brain health after mild Traumatic Brain Injury (mTBI). The study will implement a randomized controlled clinical trial of a 6 week exercise intervention (STEP) for participants with persistent mTBI symptoms, comparing STEP to standard of care practice in the controls. We will demonstrate the feasibility and acceptability of the STEP intervention. We hypothesize that STEP will lead to meaningful improvement on objective measures of self-reported mTBI symptoms, formal neuropsychological performance, and postural stability.

Official Title
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Subsymptom Threshold Exercise Protocol (STEP) to Recovery Following Mild Traumatic Brain Injury: A Pilot Randomized Controlled Clinical Trial

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: STEP
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who have sustained a concussion and have not experienced symptom resolution by 4 weeks, as indicated by a Post-Concussive Scale - Revised (PCS-R) score of 20 or higher at 4 weeks post-injury or beyond; Participants are high school and college age (14-22 years old); English speaking. - Exclusion Criteria: Outside of age range for the study (High school or college age) Have physical injuries or comorbidities that restrict the athlete from engaging in the exercise intervention Not fluent in English -

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEP arm<br>The Baseline Evaluation Session will include formal neuropsychological evaluation, postural stability evaluation, and an education session (education about mTBI, mTBI recovery, and expected outcomes from mTBI). Intervention includes exercise tolerance evaluations, 3 times per week exercise by physical therapist. Self report of symptoms and exertion. | Behavioral: STEP<br>* Physical therapists guide participants through novel set of assigned exercises<br>* Other names: Subsymptom Threshold Exercise Protocol;|
| Active Comparator: Control<br>The Baseline Evaluation Session will include formal neuropsychological evaluation, posturalstability evaluation, and an education session (education about mTBI, mTBI recovery, and expected outcomes from mTBI). Control protocol includes instructions for stretching, instructions for restricting physically demanding activity during first 3 weeks of study; instructions for light, self-guided daily exercise in last 3 weeks of study. Self report of symptoms and exertion. | Behavioral: Control<br>* Participants self-guide through standard exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concussion symptom resolution | Symptom self-reports; improvement reflected by points on the scale | 6 weeks | 
| Neuropsychological testing | Improved cognitive performance with the treatment, reflected in standard scores on cognitive measures. | 6 weeks | 
| Postural stability | Improved balance with the treatment, reflected in reductions in errors on the Balance Error Scoring System (BESS). | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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concussion, sports concussion, exercise therapy