Traumatic Brain Injury
Conditions
Keywords
concussion, sports concussion, exercise therapy
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.
Interventions
BEHAVIORALSTEP
Physical therapists guide participants through novel set of assigned exercises
BEHAVIORALControl
Participants self-guide through standard exercises
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 22 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concussion symptom resolution | 6 weeks | Symptom self-reports; improvement reflected by points on the scale |
| Neuropsychological testing | 6 weeks | Improved cognitive performance with the treatment, reflected in standard scores on cognitive measures. |
| Postural stability | 6 weeks | Improved balance with the treatment, reflected in reductions in errors on the Balance Error Scoring System (BESS). |
Countries
United States
Outcome results
None listed