Active Injury Management (AIM) After Pediatric Concussion
NCT ID: NCT03869970
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
237 participants
INTERVENTIONAL
2019-06-11
2023-08-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rest
Discharge instructions focused on 24 - 48 hours of rest then symptom guided activity, Fitbit monitored.
REST
The REST group will be recommended to return to school and light physical and cognitive activity as soon as tolerated- but no sooner than 48 hrs post-injury per current consensus recommendations. Notifications from the Fitbit app will be turned off, and step goal will be set at 500, to minimize positive feedback and reminders from achievement of activity goals
mHealth
Use of the "resilience" application on a smart phone to assess daily symptoms over 14 days and follow a self directed, symptom guided return to physical activity. Also Fitbit monitored.
mHEALTH
mHEALTH group will be instructed to download the SuperBetter© app. In addition to the pre-programmed general resilience goals, research assistants will help the subjects to set personal mental, social, and emotional rehabilitation goals and milestones for acute recovery from mTBI (e.g. return to school for ½ the day, have an improvement in symptoms). These goals/milestones will give the patient an opportunity to celebrate the achievement of improvement from mTBI with the goal of generating a positive contextual frame for recovery.
Activity
Low intensity activity regardless of symptoms using their Fitbit to measure said activity with goals (eg. 10,000 steps/ day.
ACTIVITY
ACTIVITY group will be encouraged to engage in light to moderate physical activity with the goal of reaching 10,000 steps a day for one or more days during the first week. Subjects will be encouraged to engage in low-risk activities (e.g. walking). Subjects will be instructed to avoid activities that may increase risk of re-injury (e.g. bike riding, climbing, trampoline, sports). Fitbit notifications will be turned on and step goals will be set at 10,000. The simple goal of reaching 10,000 steps is clear to patients regardless of health literacy level, and real-time feedback provides continuous motivation.
Both Activity and mHealth
This group will receive both interventions and utilize the "SuperBetter" app. Interventions will be integrated by having research assistants support the subject to set and physical activity goals and milestones to the subject's pre-programmed general resilience goals in the SuperBetter© app (e.g. take a 30 min walk, march in place for 5 minutes, increase my step count by 2000 today, achieve 10,000 steps today).
ACTIVITY
ACTIVITY group will be encouraged to engage in light to moderate physical activity with the goal of reaching 10,000 steps a day for one or more days during the first week. Subjects will be encouraged to engage in low-risk activities (e.g. walking). Subjects will be instructed to avoid activities that may increase risk of re-injury (e.g. bike riding, climbing, trampoline, sports). Fitbit notifications will be turned on and step goals will be set at 10,000. The simple goal of reaching 10,000 steps is clear to patients regardless of health literacy level, and real-time feedback provides continuous motivation.
mHEALTH
mHEALTH group will be instructed to download the SuperBetter© app. In addition to the pre-programmed general resilience goals, research assistants will help the subjects to set personal mental, social, and emotional rehabilitation goals and milestones for acute recovery from mTBI (e.g. return to school for ½ the day, have an improvement in symptoms). These goals/milestones will give the patient an opportunity to celebrate the achievement of improvement from mTBI with the goal of generating a positive contextual frame for recovery.
Interventions
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REST
The REST group will be recommended to return to school and light physical and cognitive activity as soon as tolerated- but no sooner than 48 hrs post-injury per current consensus recommendations. Notifications from the Fitbit app will be turned off, and step goal will be set at 500, to minimize positive feedback and reminders from achievement of activity goals
ACTIVITY
ACTIVITY group will be encouraged to engage in light to moderate physical activity with the goal of reaching 10,000 steps a day for one or more days during the first week. Subjects will be encouraged to engage in low-risk activities (e.g. walking). Subjects will be instructed to avoid activities that may increase risk of re-injury (e.g. bike riding, climbing, trampoline, sports). Fitbit notifications will be turned on and step goals will be set at 10,000. The simple goal of reaching 10,000 steps is clear to patients regardless of health literacy level, and real-time feedback provides continuous motivation.
mHEALTH
mHEALTH group will be instructed to download the SuperBetter© app. In addition to the pre-programmed general resilience goals, research assistants will help the subjects to set personal mental, social, and emotional rehabilitation goals and milestones for acute recovery from mTBI (e.g. return to school for ½ the day, have an improvement in symptoms). These goals/milestones will give the patient an opportunity to celebrate the achievement of improvement from mTBI with the goal of generating a positive contextual frame for recovery.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Do not have a smart phone
* History of brain surgery or past moderate/severe TBI within the last 6 months,
* Substance abuse,
* Major psychiatric condition under ongoing treatment with medications,
* Vestibular disorder,
* Cardiac condition,
* Unable to provide consent/assent
* Previous enrollment in the study
11 Years
24 Years
ALL
No
Sponsors
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Centers for Disease Control and Prevention
FED
Medical College of Wisconsin
OTHER
Responsible Party
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Danny Thomas
Associate Professor Pediatric Emergency Medicine
Principal Investigators
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Danny Thomas, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Thomas DG, Erpenbach H, Smith CN, Hickey RW, Waltzman D, Haarbauer-Krupa J, Nelson LD, Patterson CG, McCrea M, Collins MW, Kontos AP. Impact of Early Activity and Behavioral Management on Acute Concussion Recovery: A Randomized Controlled Trial. J Pediatr. 2025 Aug;283:114596. doi: 10.1016/j.jpeds.2025.114596. Epub 2025 Apr 18.
Eagle SR, Zynda AJ, Sandulli L, Hickey RW, Kegel NE, Nelson L, McCrea M, Collins MW, Okonkwo DO, Thomas DG, Kontos AP. The Role of Body Mass Index on Physical Activity, Symptoms, and Related Outcomes Following Pediatric Concussion. J Pediatr. 2025 Feb;277:114386. doi: 10.1016/j.jpeds.2024.114386. Epub 2024 Nov 1.
Other Identifiers
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PRO00033221
Identifier Type: -
Identifier Source: org_study_id