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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 3 months, 6 months

Awards & highlights

MSTEP-R01 Trial Summary

This trial will test whether a new telehealth-delivered approach to treating youth with persistent post-concussive symptoms (PPCS) is effective. The approach uses physical activity trackers and weekly video conferences with trained research staff.

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.Check my eligibility

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.See study design

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.

MSTEP-R01 Trial 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.

MSTEP-R01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 3 months, 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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

MSTEP-R01 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

302 Previous Clinical Trials

5,216,807 Total Patients Enrolled

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

1,964 Previous Clinical Trials

2,674,530 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the only subjects of this research those who are younger than 25 years old?

"This medical research study includes children aged between 11 and 18 years old, as per the inclusion criteria."

Answered by AI

How can I help researchers by being a part of this trial?

"This study is looking for 200 adolescents, aged 11 to 18, who have post-concussion syndrome. To qualify, they must also meet the following: have at least 3 concussive symptoms rated a 2 or higher on the Health and Behavior Inventory (HBI) and a total score of at least 10."

Answered by AI