200 Participants Needed

MSTEP for Concussion

(MSTEP-R01 Trial)

SP
Overseen BySara P Chrisman, MD MPH
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Seattle Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using exercise to treat concussion symptoms.

Is the Mobile Subthreshold Exercise Program (MSTEP) safe for use in humans?

Research indicates that subthreshold exercise programs, including MSTEP, are generally safe for individuals with concussion, as no adverse events were recorded in studies involving both healthy youth and those with concussion.12345

How is the MSTEP treatment for concussion different from other treatments?

MSTEP is unique because it delivers subthreshold exercise (exercise below the level that causes symptoms) virtually through telehealth, using tools like Zoom and fitness devices, making it accessible for youth in rural areas or during situations like the COVID-19 pandemic, unlike traditional treatments that require in-person visits.23467

What data supports the effectiveness of the treatment MSTEP for concussion?

Research suggests that subsymptom threshold exercise, which is part of the MSTEP program, can help reduce symptoms and improve recovery in people with persistent post-concussion symptoms. Studies have shown that structured aerobic exercise and physical interventions can lead to faster recovery and symptom improvement after a concussion.128910

Who Is on the Research Team?

SP

Sara P Chrisman, MD

Principal Investigator

University of Washington and Seattle Children's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can participate from anywhere since the study is conducted remotely.
I have had at least 3 concussion symptoms with a severity of 2 or more and a total score of 10 or higher.
I had a concussion diagnosed by a professional between 1 week and 12 months ago.

Exclusion Criteria

Children who have worked with a physical therapist to improve their cardiovascular exercise.
I have been advised against moderate to vigorous physical activity due to other injuries or medical conditions.
Children who say they are doing at least 30 minutes of heart-pumping exercise each day.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the M-STEP intervention or stretching control for 6 weeks, with weekly video conferencing and use of Fitbits for progress tracking

6 weeks
6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

6 months
3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • MSTEP
  • Stretching
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention group (MSTEP)Experimental Treatment1 Intervention
Group II: Control group (Stretching)Active Control1 Intervention

MSTEP is already approved in United States, Canada for the following indications:

🇺🇸
Approved in United States as M-STEP for:
🇨🇦
Approved in Canada as M-STEP for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials
319
Recruited
5,232,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Published Research Related to This Trial

A study involving 12 patients with post-concussion syndrome showed that subsymptom threshold exercise training is safe and leads to significant improvements in exercise capacity and reduction of PCS symptoms over 2 to 3 weeks.
Participants were able to exercise longer and at higher heart rates without exacerbating symptoms, with athletes recovering faster than nonathletes, indicating that controlled exercise can be an effective treatment for PCS.
A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome.Leddy, JJ., Kozlowski, K., Donnelly, JP., et al.[2022]
A structured aerobic exercise intervention (SAEP) significantly reduced the time to reach asymptomatic status and medical clearance in adolescents and young adults recovering from sport-related concussions, compared to usual care exercise prescriptions (UCEP).
The SAEP group experienced consistently lower symptom severity scores throughout the trial, indicating that this exercise protocol is both safe and effective for early intervention following a concussion.
Randomized controlled trial of early aerobic exercise following sport-related concussion: Progressive percentage of age-predicted maximal heart rate versus usual care.Hutchison, MG., Di Battista, AP., Lawrence, DW., et al.[2023]
Subthreshold aerobic exercise significantly reduces symptom scores in individuals with concussion, but it does not shorten the time to recovery, based on a systematic review of 12 trials.
Individually tailored multimodal interventions, which include cervical, vestibular, and oculomotor therapies, show a moderate effect in improving symptom scores and help concussed individuals with persistent symptoms return to sport more quickly.
Do physical interventions improve outcomes following concussion: a systematic review and meta-analysis?Reid, SA., Farbenblum, J., McLeod, S.[2022]

Citations

A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. [2022]
Randomized controlled trial of early aerobic exercise following sport-related concussion: Progressive percentage of age-predicted maximal heart rate versus usual care. [2023]
Do physical interventions improve outcomes following concussion: a systematic review and meta-analysis? [2022]
Outcomes Following a Vestibular Rehabilitation and Aerobic Training Program to Address Persistent Post-Concussion Symptoms. [2018]
The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. [2020]
Mobile Subthreshold Exercise Program (MSTEP) for concussion: study protocol for a randomized controlled trial. [2023]
An At-Home, Virtually Administered Graded Exertion Protocol for Use in Concussion Management: Preliminary Evaluation of Safety and Feasibility for Determining Clearance to Return to High-Intensity Exercise in Healthy Youth and Children With Subacute Concussion. [2023]
Use of Supervised Exercise During Recovery Following Sports-Related Concussion. [2021]
Pilot Study of Telehealth Delivered Rehabilitative Exercise for Youth With Concussion: The Mobile Subthreshold Exercise Program (MSTEP). [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Association of Simple Step Test With Readiness for Exercise in Youth After Concussion. [2021]
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