Subsymptom Threshold Exercise Protocol Following Mild TBI

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: STEP; Behavioral: Control

• Registration Number: NCT02267668
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Study Timeline

• Study Start: 2014-07-01
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-17
• Primary Completion: 2017-03-08
• Study Completion: 2018-03-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STEP arm	STEP	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.
Control	Control	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.

Primary Outcome Measures

Name	Time	Method
Neuropsychological testing	6 weeks	Improved cognitive performance with the treatment, reflected in standard scores on cognitive measures.
Concussion symptom resolution	6 weeks	Symptom self-reports; improvement reflected by points on the scale
Postural stability	6 weeks	Improved balance with the treatment, reflected in reductions in errors on the Balance Error Scoring System (BESS).

Trial Locations

Locations (1)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States