Concussion, BrainMSTEP-R01NCT04688255
Mobile Subthreshold Exercise Program for Concussion--R01
A study testing MSTEP and Stretching in people with Concussion, Brain and Concussion, Mild, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Approximately 1.9 million youth sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) such as headache, dizziness, and difficulty focusing that continue for weeks or months. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Concussion, Brain, Concussion, Mild, Brain Injuries, Traumatic
- What is being tested?
- MSTEP and Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to Oct 2025
- Phase
- Interventional
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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth 11-18 years
- Concussion occurring 1 week to 12 months prior to the start of the study and diagnosed by a clinician trained in concussion management consistent with the 2017 Berlin consensus definition of concussion ("A traumatic brain injury, induced by biomechanical forces")
- 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
- Can be located anywhere as all study procedures are remote
Who cannot join
- Youth not fluent in English or at least one Parent not fluent in English or Spanish
- Other injuries or medical conditions in addition to concussion that have prompted a clinician to recommend against MVPA, such as concerning abnormalities on routine brain imaging
- Youth who indicate that they are completing an average of 30 minutes per day or greater of physical activity that increases their heart rate (indicative of a minimal need for a physical activity intervention)
- Youth who have previously engaged with a Physical Therapist to increase aerobic activity
- Youth who have been fully cleared for sport
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Childrens Hospital
Seattle, Washington, 98104
About this study
Official title: Randomized Controlled Trial Using Telehealth-delivered Rehabilitative Exercise to Treat Youth With Prolonged Concussion Recovery (Mobile Subthreshold Exercise Program, MSTEP-R01)
Approximately 1.9 million youth sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) such as headache, dizziness, and difficulty focusing that continue for weeks or months. PPCS results in greater utilization of sub-specialty care and can impact immediate and long-term social development, cognitive function and academic success. Previous recommendations for treating PPCS have focused on cognitive and physical rest, but more recently guidelines have shifted based on new research suggesting the benefit of rehabilitative exercise for PPCS. The rationale behind using exercise to treat youth with concussion is that gradually increasing physical activity facilitates return to full function. Rehabilitative exercise has since become one of the most common approaches to treating youth with PPCS, but access is challenging since most programs require weekly centralized visits with a concussion specialist. To bridge this gap, the investigators developed a telehealth-delivered approach to treat PPCS, utilizing physical activity trackers (Fitbits) and weekly video conferences with trained research staff. They then conducted a series of pilot studies with this approach, finding excellent feasibility, acceptability, and evidence for more rapid declines in concussive symptoms compared to controls. The investigators also found preliminary evidence that mechanisms behind this intervention may stem from both physiologic processes due to increased moderate-to-vigorous physical activity (MVPA) and psychologic processes such as reducing fear- avoidance of concussive symptoms. They now propose a fully-powered randomized controlled trial (RCT) to asses the efficacy of the "Mobile Subthreshold Exercise Program" (M-STEP) for treating youth with PPCS.
Read the detailed description
The investigators will recruit n=200 youth 11-18 years old with PPCS. Youth will be randomized to 6 weeks of either usual care plus M-STEP (intervention) or usual care plus stretching (control). Youth in M-STEP will be coached through gradual increases in intensity and duration of rehabilitative exercise via weekly video conferencing (Zoom) and will use Fitbits to guide their progress. Youth in the stretching group will act as attention controls. All youth will complete research-grade measures at multiple time points. Youth will be followed for a total of 6 months. Data will be analyzed using mixed effects models to examine differences between experimental groups in the primary outcome, trajectory of concussive symptoms, and the secondary outcome, changes over time in health-related quality of life, on an intention-to-treat basis. Potential mediators of the treatment effect will also be examined, including fear-avoidance of concussive symptoms and MVPA, and explore the impact of factors such as patient sex and parental protective behaviors.
The investigators thus assert the following hypotheses:
Hypothesis 1: M-STEP youth will have more rapid declines in HBI and improvement in PedsQL compared to control youth
Hypothesis 2: M-STEP youth will have greater increases in MVPA over time than control youth, and these increases will predict more rapid improvement in HBI and PedsQL.
Hypothesis 3: M-STEP youth will have steeper declines in fear-avoidance compared to control youth, and these declines will predict more rapid improvement in HBI and PedsQL.
IMPACT: The proposed study will definitively answer the question of whether a mobile sub-threshold exercise program (M-STEP) improves outcomes for youth with PPCS. It will also provide essential information about both the long-term impact of this intervention and potential mediators as well as biopsychosocial factors that influence treatment response. The study design uses a rigorous protocolized smartphone administered mHealth intervention that will be readily reproducible and generalizable to the majority of youth with PPCS. If successful, this will be one of the few evidenced-based interventions available to treat youth with PPCS.
- Conditions
- Concussion, Brain, Concussion, Mild, Brain Injuries, Traumatic, Persistent Post Traumatic Headache, Post-Concussion Syndrome, Post-Concussive Syndrome, Chronic
- Being tested
- MSTEP, Stretching
- Keywords
- Traumatic brain injury, Concussion, Exercise, Physical activity, Subthreshold, Treatment, Pediatric, Child
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic, Post-Concussion Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSTEPBehavioural
Aerobic exercise that is advanced weekly
StretchingBehavioural
Stretching exercises that are advanced weekly
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (MSTEP) | Experimental | 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. Receives: Behavioral: MSTEP |
| Control group (Stretching) | Active comparator | 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. Receives: Behavioral: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concussive symptoms (Health Behavior Inventory, HBI)--youth, a 21 item 0-3 likert scale with higher scores indicating more severe symptoms
Examine trajectory of concussive symptoms over time. The central hypothesis is that the intervention group will have a more rapid decline in concussive symptoms..
Measured: Baseline, weekly during the intervention (x6 weeks), 3 months and 6 months.
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
Examine trajectory of concussive symptoms over time. The central hypothesis is that the intervention group will have a more rapid improvement in health-related quality of life.
Measured: Baseline, 6 weeks, 3 months and 6 months.
Secondary outcomes (2)
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
Examine trajectory of fear-avoidance over time and assess for mediation of change in concussive symptoms. The central hypothesis is that decreases in fear-avoidance of concussive symptoms will partially mediate the decline in concussive symptoms.
Measured: Baseline, 6 weeks, 3 months and 6 months.
Moderate-Vigorous Physical Activity (MVPA), measured with hip-mounted actigraphy
Examine trajectory of MVPA over time and assess for mediation of change in concussive symptoms. The central hypothesis is that increases in MVPA will partially mediate the decline in concussive symptoms.
Measured: Baseline, 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start22 Mar 2021
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies 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
- Model description
- Randomized controlled trial (RCT)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sara PD Chrisman, MD MPH, Seattle Children's Hospital
- Investigators
- Sara P Chrisman, MD MPH, Principal investigator, University of Washington and Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688255
- Sponsor's protocol ID
- 00002697
- Other IDs
- 1R01HD094722-01A1
- Acronym
- MSTEP-R01
- Status last verified
- May 2025
- First submitted
- 23 Dec 2020
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chrisman SPD, Whitlock KB, Mendoza JA, Burton MS, Somers E, Hsu A, Fay L, Palermo TM, Rivara FP. Pilot Randomized Controlled Trial of an Exercise Program Requiring Minimal In-person Visits for Youth With Persistent Sport-Related Concussion. Front Neurol. 2019 Jun 17;10:623. doi: 10.3389/fneur.2019.00623. eCollection 2019.
PubMed 31316446Chrisman SPD, Whitlock KB, Somers E, Burton MS, Herring SA, Rowhani-Rahbar A, Rivara FP. Pilot study of the Sub-Symptom Threshold Exercise Program (SSTEP) for persistent concussion symptoms in youth. NeuroRehabilitation. 2017;40(4):493-499. doi: 10.3233/NRE-161436.
PubMed 28222566Chrisman SPD, Bollinger BJ, Flaat A, Sahlberg J, Zhou C, Mendoza JA, Brooks MA, Palermo TM, Hansen CR, Rivara FP. Mobile Subthreshold Exercise Program (MSTEP) for Youth With Prolonged Concussion Recovery: A Randomized Clinical Trial. JAMA Pediatr. 2026 Oct 19. doi: 10.1001/jamapediatrics.2026.4927. Online ahead of print.
PubMed 42895728Chrisman SPD, Zhou C, Sahlberg J, Bollinger BJ, Hansen C, Mendoza JA, Brooks MA, Rivara FP, Palermo TM. Psychometrics of a fear-avoidance measure adapted for youth with persistent postconcussive symptoms: Fear of Concussive Symptoms Questionnaire (FOCSQ) child and parent-proxy versions. Neuropsychology. 2026 Jan;40(1):108-115. doi: 10.1037/neu0001031. Epub 2025 Oct 2.
PubMed 41037445Chrisman SPD, Bollinger BJ, Mendoza JA, Palermo TM, Zhou C, Brooks MA, Rivara FP. Mobile Subthreshold Exercise Program (MSTEP) for concussion: study protocol for a randomized controlled trial. Trials. 2022 Apr 26;23(1):355. doi: 10.1186/s13063-022-06239-3.
PubMed 35473570