Subsymptom Threshold Exercise Protocol Following Mild TBI

University Hospitals Cleveland Medical Center16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

STEPBEHAVIORAL

Physical therapists guide participants through novel set of assigned exercises

ControlBEHAVIORAL

Participants self-guide through standard exercises

Eligibility

Sex: ALLMin age: 14 YearsMax age: 22 Years

Medical Language ↔ Plain English

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 -

Locations (1)

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Concussion symptom resolution

Symptom self-reports; improvement reflected by points on the scale

Time frame: 6 weeks

Neuropsychological testing

Improved cognitive performance with the treatment, reflected in standard scores on cognitive measures.

Time frame: 6 weeks

Postural stability

Improved balance with the treatment, reflected in reductions in errors on the Balance Error Scoring System (BESS).

Time frame: 6 weeks

Data from ClinicalTrials.gov

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