Brain ConcussionM-STEPNCT03691363
Mobile Subthreshold Exercise Program for Concussion
A study testing M-STEP in people with Brain Concussion, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Non-randomized pilot intervention using mobile-administered sub-threshold exercise to treat youth with prolonged symptoms of concussion. Read more about this study
- Who is it for?
- Ages 9 to 25 years
- Conditions the study is for
- Brain Concussion
- What is being tested?
- M-STEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Concussion diagnosed by a healthcare provider that occurred 2 weeks-6 months ago
- Continued symptoms with at least 3 symptoms on the HBI and a score of 20+
- No other issues that would preclude physical activity
- Parents and youth are English-speaking
Who cannot join
- Already participating in >30 minutes of MVPA/day
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98104
About this study
Official title: Mobile Subthreshold Exercise Program (M-STEP) for Concussion
Non-randomized pilot intervention using mobile-administered sub-threshold exercise to treat youth with prolonged symptoms of concussion.
Read the detailed description
6-week pilot study of a novel intervention for concussion, administering a sub-threshold exercise program in a mobile fashion using video conferencing and providing feedback using wrist-worn accelerometry and heart rate monitoring.
- Conditions
- Brain Concussion
- Being tested
- M-STEP
- Keywords
- child, Adolescent, exercise, rehabilitation, physical activity, virtual, mobile health
- Medical subject headings
- Brain Concussion, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-STEPBehavioural
Also called Sub-threshold exercise
Youth will be assessed using actigraphy at baseline, and will then be asked to exercise for 1) a duration of 10 minutes > MVPA at baseline with 2) HR>120 while being monitored by a Fitbit. Youth will be asked to exercise daily, and intensity and duration will be increased every few days for a goal of 60 minutes per day at a HR>140 (low end of MVPA). The intervention will be 6 weeks in duration.
| Study group | Role | What they receive |
|---|---|---|
| M-STEP | Experimental | Mobile exercise intervention Receives: Behavioral: M-STEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health Behavior Inventory (HBI), 21 item 0-3 likert, higher scores indicate more severe symptoms
Self-report questionnaire regarding concussive symptoms
Measured: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Secondary outcomes (6)
Change in Pediatric Quality of Life Inventory (PedsQL), 23 item 0-4 likert, converted to a 0-100 scale, higher scores indicate improved function
Self-report questionnaire regarding Health-related quality of life
Measured: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Change in Fear of pain questionnaire (FOPQ)-P/C, adapted for concussion, 24 item (child) and 23 item (parent) 0-4 likert, higher scores indicate greater fear-avoidance
Self-report questionnaire completed by parent and child regarding their fear of concussive symptoms and avoidance of activities that might produce concussive symptoms
Measured: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Change in Patient Health Questionnaire 9 (PHQ-9), 9 item 0-3 likert, higher scores indicate greater symptoms
Self-report questionnaire of depression symptoms
Measured: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Change in Adolescent Sleep Wake Scale (ASWS), 10-item 0-5 likert, higher scores indicate improved sleep quality
Self-report 10-item questionnaire regarding difficulty falling asleep, night wakenings and other sleep issues
Measured: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Change in Generalized anxiety disorder--7 item (GAD7), 7-item 0-3 likert, higher scores indicate more severe symptoms
Self-report questionnaire regarding anxiety symptoms (7-item)
Measured: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Study Satisfaction Questionnaire
8 item survey regarding satisfaction with study, 0-3 likert, higher scores indicate greater satisfaction
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start6 Mar 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All youth will receive the intervention
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara PD Chrisman, MD MPH, Seattle Children's Hospital
- Investigators
- Sara PD Chrisman, MD, MPH, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691363
- Sponsor's protocol ID
- 00001039
- Acronym
- M-STEP
- Status last verified
- Jan 2021
- First submitted
- 27 Sep 2018
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chrisman SPD, Mendoza JA, Zhou C, Palermo TM, Gogue-Garcia T, Janz KF, Rivara FP. Pilot Study of Telehealth Delivered Rehabilitative Exercise for Youth With Concussion: The Mobile Subthreshold Exercise Program (MSTEP). Front Pediatr. 2021 May 28;9:645814. doi: 10.3389/fped.2021.645814. eCollection 2021.
PubMed 34123963
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Subthreshold Exercise Program (M-STEP) for Concussion
- ClinicalTrials.gov ID
- NCT03691363
- Acronym / sponsor ID
- M-STEP / 00001039
- Conditions
- Brain Concussion
- Keywords
- child, Adolescent, exercise, rehabilitation, physical activity, virtual, mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-randomized pilot intervention using mobile-administered sub-threshold exercise to treat youth with prolonged symptoms of concussion.
Detailed description
6-week pilot study of a novel intervention for concussion, administering a sub-threshold exercise program in a mobile fashion using video conferencing and providing feedback using wrist-worn accelerometry and heart rate monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All youth will receive the intervention
| Arm | Type | Receives |
|---|---|---|
| M-STEP | Experimental | Behavioral: M-STEPMobile exercise intervention |
Who may qualify
- Ages
- 9 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Concussion diagnosed by a healthcare provider that occurred 2 weeks-6 months ago
- Continued symptoms with at least 3 symptoms on the HBI and a score of 20+
- No other issues that would preclude physical activity
- Parents and youth are English-speaking
Key exclusion criteria (1 listed)
- Already participating in >30 minutes of MVPA/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-STEPAlso: Sub-threshold exerciseYouth will be assessed using actigraphy at baseline, and will then be asked to exercise for 1) a duration of 10 minutes > MVPA at baseline with 2) HR>120 while being monitored by a Fitbit. Youth will be asked to exercise daily, and intensity and duration will be increased every few days for a goal of 60 minutes per day at a HR>140 (low end of MVPA). The intervention will be 6 weeks in duration. | Behavioural | M-STEP |
Primary outcome
Change in Health Behavior Inventory (HBI), 21 item 0-3 likert, higher scores indicate more severe symptoms
Time frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Self-report questionnaire regarding concussive symptoms
6 secondary outcomes
Change in Pediatric Quality of Life Inventory (PedsQL), 23 item 0-4 likert, converted to a 0-100 scale, higher scores indicate improved function
Time frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Change in Fear of pain questionnaire (FOPQ)-P/C, adapted for concussion, 24 item (child) and 23 item (parent) 0-4 likert, higher scores indicate greater fear-avoidance
Time frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Change in Patient Health Questionnaire 9 (PHQ-9), 9 item 0-3 likert, higher scores indicate greater symptoms
Time frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Change in Adolescent Sleep Wake Scale (ASWS), 10-item 0-5 likert, higher scores indicate improved sleep quality
Time frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Change in Generalized anxiety disorder--7 item (GAD7), 7-item 0-3 likert, higher scores indicate more severe symptoms
Time frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Study Satisfaction Questionnaire
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Derived from this study: PubMed 34123963Chrisman SPD, Mendoza JA, Zhou C, Palermo TM, Gogue-Garcia T, Janz KF, Rivara FP. Pilot Study of Telehealth Delivered Rehabilitative Exercise for Youth With Concussion: The Mobile Subthreshold Exercise Program (MSTEP). Front Pediatr. 2021 May 28;9:645814. doi: 10.3389/fped.2021.645814. eCollection 2021.
Related trials for Brain Concussion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara PD Chrisman, MD, MPH principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-STEP in people with Brain Concussion, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health Behavior Inventory (HBI), 21 item 0-3 likert, higher scores indicate more severe symptoms (time frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021; AzTrials last refreshed its copy on 28 Oct 2026.