Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Mobile Subthreshold Exercise Program for Concussion--R01
NCT04688255 · View on ClinicalTrials.gov ↗
Study 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. 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.
Conditions Studied
Interventions
- BEHAVIORAL Stretching
- BEHAVIORAL MSTEP
Study Locations (1)
Washington
- Seattle Childrens Hospital — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-03-22 |
| Est. Completion | 2025-10 |
| Phase | NA |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04688255
The ClinicalTrials.gov registry entry for NCT04688255 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 127 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Brain Injuries, Traumatic appearing as the primary indexed condition, and to 2 interventions — of which Stretching is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04688255 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04688255 about?
NCT04688255 is a clinical study titled "Mobile Subthreshold Exercise Program for Concussion--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 immedia...
What is the current status of trial NCT04688255?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2021-03-22. Estimated completion is 2025-10.
What conditions does trial NCT04688255 study?
This clinical trial studies the following conditions: Brain Injuries, Traumatic, Concussion, Brain, Concussion, Mild, Post-Concussion Syndrome, Post-Concussive Syndrome, Chronic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04688255?
The interventions under investigation include: Stretching (BEHAVIORAL), MSTEP (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04688255?
This trial is sponsored by Seattle Children's Hospital, which has 127 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04688255 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.