NCT02267668

Subsymptom Threshold Exercise Protocol Following Mild TBI

Subsymptom Threshold Exercise Protocol (STEP) to Recovery Following Mild Traumatic Brain Injury: A Pilot Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 14 Years – 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	STEP	Physical therapists guide participants through novel set of assigned exercises
BEHAVIORAL	Control	Participants self-guide through standard exercises

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-03-08
• Completion: 2018-03-08
• First posted: 2014-10-17
• Last updated: 2018-05-14

Locations

1 site across 1 country: United States