Subsymptom Threshold Exercise Protocol Following Mild TBI



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:14 - 22
Updated:5/16/2018
Start Date:July 1, 2014
End Date:March 8, 2018

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

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

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.

Inclusion Criteria:

1. 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;

2. Participants are high school and college age (14-22 years old);

3. English speaking. -

Exclusion Criteria:

1. Outside of age range for the study (High school or college age)

2. Have physical injuries or comorbidities that restrict the athlete from engaging in the
exercise intervention

3. Not fluent in English -
We found this trial at
1
site
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mi
from
Cleveland, OH
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