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MSTEP for Concussion (MSTEP-R01 Trial)

N/A
Recruiting
Led By Sara P Chrisman, MD MPH
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Persistent post-concussive symptoms as defined by the presence of at least 3 concussive symptoms rated at least 2 or greater on the Health and Behavior Inventory (HBI) and a total score of at least 10
Youth 11-18 years
Must not have
Youth not fluent in English or at least one Parent not fluent in English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 3 months, 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new exercise program called M-STEP that uses fitness trackers and video calls to help young people aged 11-18 recover from long-lasting concussion symptoms. The program aims to speed up recovery by gradually increasing physical activity and reducing fear of symptoms.

Who is the study for?
This trial is for English or Spanish-speaking youth aged 11-18 with persistent post-concussive symptoms from a concussion diagnosed between 1 week to 12 months prior. Participants must have at least three concussive symptoms and minimal current physical activity. Those already cleared for sports or treated by a Physical Therapist for aerobic activity are excluded.
What is being tested?
The 'Mobile Subthreshold Exercise Program' (M-STEP) is being tested, which uses Fitbits and weekly video calls to guide youths with post-concussion syndrome through rehabilitative exercises remotely, aiming to improve their symptoms more rapidly than standard care.
What are the potential side effects?
Potential side effects may include an increase in concussive symptoms like headaches or dizziness if the exercise program is not properly followed. However, since this involves light stretching and gradual exercise, severe side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least 3 concussion symptoms with a severity of 2 or more and a total score of 10 or higher.
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I am between 11 and 18 years old.
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I am between 11 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I, or one of my parents, do not speak English or Spanish fluently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concussive symptoms (Health Behavior Inventory, HBI)--youth, a 21 item 0-3 likert scale with higher scores indicating more severe symptoms
Pediatric Quality of Life (PEDsQL, parent and youth), a 23 item 0-4 likert scale that is scaled to 0-100 with higher scores indicating better function
Secondary study objectives
Fear of Pain Questionnaire (FOPQ, parent and youth), adapted for concussive symptoms, 24 item (child) and 23 item (parent) 0-4 likert scales with higher scores indicating greater fear-avoidance
Moderate-Vigorous Physical Activity (MVPA), measured with hip-mounted actigraphy
Other study objectives
Adolescent Sleep Wake Scale (ASWS)-10, standardized survey (self-report) regarding sleep quality, a 10-item 0-5 likert scale reported as the mean with higher scores indicating improved sleep quality
Generalized Anxiety Disorder Scale-7 (GAD-7), standardized measure of anxiety symptoms, a 7-item 0-3 likert scale with higher scores indicating more severe symptoms
Patient Health Questionnaire-9 (PHQ-9), standardized measure of depressive symptoms, a 9-item 0-3 likert scale with higher scores indicating more severe symptoms

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention group (MSTEP)Experimental Treatment1 Intervention
REHABILITATIVE EXERCISE: Participants will be asked to exercise at home daily for 6 weeks, meeting with an RA weekly via video conference to gradually increase the intensity and duration of exercise based on symptom tolerance. The eventual goal will be to achieve 60 minutes of MVPA daily (US Federal recommendations). They will wear a personal fitness device (Fitbit) to track whether they are achieving their HR goals.
Group II: Control group (Stretching)Active Control1 Intervention
STRETCHING: Participants will be asked to complete stretches daily. They will initially be given two stretches, primarily focused on the neck and upper back. Additional stretches will be added through weekly discussions with the study RA.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Traumatic Brain Injury (TBI) focus on maintaining adequate cerebral blood flow and managing intracranial pressure to prevent secondary injury. This includes the use of rapid sequence induction and intubation (RSII), low-dose inhalation agents, opioids, and total intravenous anesthesia (TIVA) for patients with increased intracranial pressure. The Mobile Subthreshold Exercise Program (M-STEP) aligns with these principles by promoting increased moderate-to-vigorous physical activity (MVPA) and reducing fear-avoidance behaviors. This approach is beneficial for TBI patients as it helps in the gradual return to full function, potentially reducing persistent post-concussive symptoms such as headaches and dizziness. By addressing both physiological and psychological aspects, these treatments aim to improve overall recovery and quality of life for TBI patients.
The Role of Active Rehabilitation in Concussion Management: A Systematic Review and Meta-analysis.

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
310 Previous Clinical Trials
5,230,894 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,043 Previous Clinical Trials
2,730,089 Total Patients Enrolled
Sara P Chrisman, MD MPHPrincipal InvestigatorUniversity of Washington and Seattle Children's Hospital
2 Previous Clinical Trials
404 Total Patients Enrolled

Media Library

MSTEP Clinical Trial Eligibility Overview. Trial Name: NCT04688255 — N/A
Traumatic Brain Injury Research Study Groups: Intervention group (MSTEP), Control group (Stretching)
Traumatic Brain Injury Clinical Trial 2023: MSTEP Highlights & Side Effects. Trial Name: NCT04688255 — N/A
MSTEP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04688255 — N/A
~21 spots leftby Apr 2025