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NCT04688255 · ClinicalTrials.gov registry record · NA
Mobile Subthreshold Exercise Program for Concussion--R01
A NA study of Brain Injuries, Traumatic and Concussion, Brain, sponsored by Seattle Children's Hospital.
- Active
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT04688255 is a NA study of Brain Injuries, Traumatic and Concussion, Brain that is active but no longer recruiting, run by Seattle Children's Hospital. The registered enrollment target is 200 participants, below the 247-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (19% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04688255, a NA study of Brain Injuries, Traumatic and Concussion, Brain, is active but no longer recruiting, sponsored by Seattle Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
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?
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, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 247-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (19% lower). The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
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.
NCT04688255 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
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.
What interventions are being tested in trial NCT04688255?
The interventions under investigation include: Stretching (BEHAVIORAL), MSTEP (BEHAVIORAL).
Who is sponsoring clinical trial NCT04688255?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
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.
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