Traumatic Brain InjurySTEPNCT02267668
Subsymptom Threshold Exercise Protocol Following Mild TBI
A study testing STEP in people with Traumatic Brain Injury, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The study will monitor outcomes of two interventions to develop a best practice in the treatment of mild Traumatic Brain Injury (mTBI). Read more about this study
- Who is it for?
- Ages 14 to 22 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- STEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2014to 8 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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. -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Subsymptom Threshold Exercise Protocol (STEP) to Recovery Following Mild Traumatic Brain Injury: A Pilot Randomized Controlled Clinical Trial
The study will monitor outcomes of two interventions to develop a best practice in the treatment of mild Traumatic Brain Injury (mTBI).
Read the 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
- Being tested
- STEP, Control
- Keywords
- concussion, sports concussion, exercise therapy
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPBehavioural
Also called Subsymptom Threshold Exercise Protocol
Physical therapists guide participants through novel set of assigned exercises
ControlBehavioural
Participants self-guide through standard exercises
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concussion symptom resolution
Symptom self-reports; improvement reflected by points on the scale
Measured: 6 weeks
Neuropsychological testing
Improved cognitive performance with the treatment, reflected in standard scores on cognitive measures.
Measured: 6 weeks
Postural stability
Improved balance with the treatment, reflected in reductions in errors on the Balance Error Scoring System (BESS).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study start1 Jul 2014
- Primary completion8 Mar 2017
- Study completion8 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher M. Bailey, University Hospitals Cleveland Medical Center
- Investigators
- Christopher Bailey, PhD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267668
- Sponsor's protocol ID
- 11-13-04
- Acronym
- STEP
- Status last verified
- May 2018
- First submitted
- 14 Oct 2014
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21976115Gagnon 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.
PubMed 19831492
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subsymptom Threshold Exercise Protocol (STEP) to Recovery Following Mild Traumatic Brain Injury: A Pilot Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02267668
- Acronym / sponsor ID
- STEP / 11-13-04
- Conditions
- Traumatic Brain Injury
- Keywords
- concussion, sports concussion, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEP arm | Experimental | Behavioral: STEPThe 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. |
| Control | Active comparator | Behavioral: ControlThe 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. |
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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. -
Key exclusion criteria (3 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEPAlso: Subsymptom Threshold Exercise ProtocolPhysical therapists guide participants through novel set of assigned exercises | Behavioural | STEP arm |
| ControlParticipants self-guide through standard exercises | Behavioural | Control |
Primary outcome
Concussion symptom resolution
Time frame: 6 weeks
Symptom self-reports; improvement reflected by points on the scale
Neuropsychological testing
Time frame: 6 weeks
Improved cognitive performance with the treatment, reflected in standard scores on cognitive measures.
Postural stability
Time frame: 6 weeks
Improved balance with the treatment, reflected in reductions in errors on the Balance Error Scoring System (BESS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Background: PubMed 21976115Centers 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.
- Background: PubMed 19831492Gagnon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Bailey, PhD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEP in people with Traumatic Brain Injury, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concussion symptom resolution (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02267668, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.