NCT02267668

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2018

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

2.7 years

First QC Date

October 14, 2014

Last Update Submit

May 8, 2018

Conditions

Traumatic Brain Injury

Keywords

concussionsports concussionexercise therapy

Outcome Measures

Primary Outcomes (3)

  • Concussion symptom resolution

    Symptom self-reports; improvement reflected by points on the scale

    6 weeks

  • Neuropsychological testing

    Improved cognitive performance with the treatment, reflected in standard scores on cognitive measures.

    6 weeks

  • Postural stability

    Improved balance with the treatment, reflected in reductions in errors on the Balance Error Scoring System (BESS).

    6 weeks

Study Arms (2)

STEP arm

EXPERIMENTAL

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.

Behavioral: STEP

Control

ACTIVE COMPARATOR

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.

Behavioral: Control

Interventions

STEPBEHAVIORAL

Physical therapists guide participants through novel set of assigned exercises

Also known as: Subsymptom Threshold Exercise Protocol
STEP arm
ControlBEHAVIORAL

Participants self-guide through standard exercises

Control

Eligibility Criteria

Age14 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related 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.

    PMID: 21976115BACKGROUND

  • 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.

    PMID: 19831492BACKGROUND

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Concussion

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesHead Injuries, ClosedWounds, Nonpenetrating

Study Officials

  • Christopher Bailey, PhD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neuropsychologist and Director of Concussion Program, Neurological Institute

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 17, 2014

Study Start

July 1, 2014

Primary Completion

March 8, 2017

Study Completion

March 8, 2018

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations

US(1)