Subsymptom Threshold Exercise Protocol Following Mild TBI (STEP)

University Hospitals (UH)

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Behavioral: STEP; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02267668

11-13-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 14 to 22 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

STEP arm

Experimental group

Description:

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.

Treatment:

Behavioral: STEP

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control