Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT02267668
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2014-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subsymptom Threshold Exercise Protocol Following Mild TBI
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
Study Overview
Official Title:
Subsymptom Threshold Exercise Protocol (STEP) to Recovery Following Mild Traumatic Brain Injury: A Pilot Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: