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Subsymptom Threshold Exercise Protocol Following Mild TBI (STEP)

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEP
Control
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring concussion, sports concussion, exercise therapy

Eligibility Criteria

14 Years - 22 Years (Child, Adult)All SexesDoes not accept 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 -

Sites / Locations

  • University Hospitals Case Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STEP arm

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 14, 2014
Last Updated
May 8, 2018
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02267668
Brief Title
Subsymptom Threshold Exercise Protocol Following Mild TBI
Acronym
STEP
Official Title
Subsymptom Threshold Exercise Protocol (STEP) to Recovery Following Mild Traumatic Brain Injury: A Pilot Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2014 (Actual)
Primary Completion Date
March 8, 2017 (Actual)
Study Completion Date
March 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
concussion, sports concussion, exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STEP arm
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
STEP
Other Intervention Name(s)
Subsymptom Threshold Exercise Protocol
Intervention Description
Physical therapists guide participants through novel set of assigned exercises
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Participants self-guide through standard exercises
Primary Outcome Measure Information:
Title
Concussion symptom resolution
Description
Symptom self-reports; improvement reflected by points on the scale
Time Frame
6 weeks
Title
Neuropsychological testing
Description
Improved cognitive performance with the treatment, reflected in standard scores on cognitive measures.
Time Frame
6 weeks
Title
Postural stability
Description
Improved balance with the treatment, reflected in reductions in errors on the Balance Error Scoring System (BESS).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Participants are high school and college age (14-22 years old); English speaking. - Exclusion Criteria: Outside of age range for the study (High school or college age) Have physical injuries or comorbidities that restrict the athlete from engaging in the exercise intervention Not fluent in English -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Bailey, PhD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21976115
Citation
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.
Results Reference
background
PubMed Identifier
19831492
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.
Results Reference
background

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Subsymptom Threshold Exercise Protocol Following Mild TBI

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