Subsymptom Threshold Exercise Protocol (STEP) to Recovery Following Mild Traumatic Brain Injury: A Pilot Randomized Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- University Hospitals Cleveland Medical Center
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Neuropsychological testing
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The study will monitor outcomes of two interventions to develop a best practice in the treatment of mild Traumatic Brain Injury (mTBI).
Detailed Description
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.
Investigators
Christopher M. Bailey
Neuropsychologist and Director of Concussion Program, Neurological Institute
University Hospitals Cleveland Medical Center
Eligibility Criteria
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 -
Outcomes
Primary Outcomes
Neuropsychological testing
Time Frame: 6 weeks
Improved cognitive performance with the treatment, reflected in standard scores on cognitive measures.
Concussion symptom resolution
Time Frame: 6 weeks
Symptom self-reports; improvement reflected by points on the scale
Postural stability
Time Frame: 6 weeks
Improved balance with the treatment, reflected in reductions in errors on the Balance Error Scoring System (BESS).