Subsymptom Threshold Exercise Protocol Following Mild TBI

Traumatic Brain Injury Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267668
• Other study ID #: 11-13-04
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: March 8, 2018

Study information

• Verified date: May 2018
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 8, 2018
• Est. primary completion date: March 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 22 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Behavioral:
• STEP
Physical therapists guide participants through novel set of assigned exercises
• Control
Participants self-guide through standard exercises

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Centers for Disease Control and Prevention. Nonfatal traumatic brain injuries related to sports and recreation activities among persons aged =19 years--United States, 2001-2009. MMWR Morb Mortal Wkly Rep. 2011 Oct 7;60(39):1337-42. — View Citation

Gagnon I, Galli C, Friedman D, Grilli L, Iverson GL. Active rehabilitation for children who are slow to recover following sport-related concussion. Brain Inj. 2009 Nov;23(12):956-64. doi: 10.3109/02699050903373477. — View Citation

Outcome

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