What side effects are associated with this type of intervention?

The most common treatments for Traumatic Brain Injury (TBI) that involve increased moderate-to-vigorous physical activity (MVPA) and reducing fear-avoidance behaviors generally have minimal side effects. However, patients may experience temporary exacerbation of symptoms such as headaches, dizziness, or fatigue during or after physical activity. It is crucial to monitor and adjust the intensity of exercise to stay below the threshold that worsens symptoms. Additionally, psychological interventions aimed at reducing fear-avoidance behaviors are generally well-tolerated but may cause temporary emotional discomfort as patients confront their fears. Overall, these treatments are considered safe and beneficial when properly supervised.

What prior FDA approvals exist?

There are no specific FDA-approved pharmacologic treatments for Traumatic Brain Injury (TBI) that focus on increasing moderate-to-vigorous physical activity (MVPA) and reducing fear-avoidance behaviors, as seen in the Mobile Subthreshold Exercise Program (M-STEP). Current management of TBI primarily involves supportive care, rehabilitation therapies, and symptom management. Rehabilitation often includes physical therapy, occupational therapy, and cognitive therapy to help improve function and reduce symptoms. The M-STEP trial represents an innovative approach by incorporating telehealth and physical activity trackers to facilitate recovery in youth with persistent post-concussive symptoms.

What other types of research exist?

Promising novel alternatives to M-STEP for TBI patients include: 1) Early subthreshold aerobic exercise programs, which involve controlled, low-intensity physical activity soon after injury to promote recovery. 2) Vestibular rehabilitation combined with aerobic training, which addresses balance and dizziness issues while improving overall physical fitness. 3) Telehealth-delivered exercise programs, utilizing wearable technology and remote monitoring to provide personalized, accessible rehabilitation. 4) Cognitive-behavioral therapy (CBT) integrated with physical exercise, targeting both psychological and physical aspects of recovery.

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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

Must not have

Youth not fluent in English or at least one Parent not fluent in English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had at least 3 concussion symptoms with a severity of 2 or more and a total score of 10 or higher.

Select...

I am between 11 and 18 years old.

Select...

I am between 11 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I, or one of my parents, do not speak English or Spanish fluently.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Traumatic Brain Injury (TBI) focus on maintaining adequate cerebral blood flow and managing intracranial pressure to prevent secondary injury. This includes the use of rapid sequence induction and intubation (RSII), low-dose inhalation agents, opioids, and total intravenous anesthesia (TIVA) for patients with increased intracranial pressure. The Mobile Subthreshold Exercise Program (M-STEP) aligns with these principles by promoting increased moderate-to-vigorous physical activity (MVPA) and reducing fear-avoidance behaviors. This approach is beneficial for TBI patients as it helps in the gradual return to full function, potentially reducing persistent post-concussive symptoms such as headaches and dizziness. By addressing both physiological and psychological aspects, these treatments aim to improve overall recovery and quality of life for TBI patients.

The Role of Active Rehabilitation in Concussion Management: A Systematic Review and Meta-analysis.