Clinical trial NCT03869970: Active Injury Management (AIM) After Pediatric Concussion
Official title: Active Injury Management (AIM) After Pediatric Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Keywords: Concussion
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2019-03-11
Enrollment: 237
Sex: ALL
Minimum age (years): 11
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed interventions of this study will determine the ideal discharge recommendations related to activity

Detailed description: The investigators will conduct a phase II factorial clinical trial . The clinical trial will determine the benefit of prescribed low-intensity physical activity, behavioral management, or both, versus standard rest in acute (24-48 hrs) (Moderate Traumatic Brain Injury (mTBI) patients presenting to the pediatric Emergency Department (ED). Low-intensity physical activity (i.e.10,000 steps/day) will be prescribed and monitored in the first week post-injury with an actigraph (Fitbit®). Behavioral management will be prescribed using a phone app referred to as mHealth (mobile Health, specifically SuperBetter©) that promotes mental, physical, social, and emotional resilience. This randomized clinical trial will have four treatment groups: 1) activity, 2) mHealth, 3) activity+mHealth, 4) rest. The primary study outcomes will be symptoms and recovery by 14 days. All subjects will be assessed via phone at 3-5 days and in person at 14 days. The secondary outcomes will be to determine the influence of interventions on comprehensive aspects of physiologic recovery and patient-centered outcomes; including symptoms at 3 days, neurocognitive, vestibular/ocular motor impairment at 14 days, pediatric quality of life measures, time to symptom resolution, and return to normal activity via phone survey at 1 and 2 months. The investigators will assess symptom, quality of life, and recovery outcomes based on treatment group assignment for all subjects and high-risk subjects.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of mTBI in the past 72 hours

Exclusion Criteria:

* Patients having conditions otherwise which limit physical activity or neurocognitive assessment
* 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

Primary outcomes:
measure: Change in Post-Concussion Symptoms Scale (PCSS)
timeFrame: Day 0, Day 10-14
measure: Change in Pediatric Quality of Life Measures (PedsQL)
timeFrame: Day 0, Day 10-14,
measure: Fitbit Flex 2 Actigraph
timeFrame: Day 0-14
Secondary outcomes:
measure: Symptom Tracking Assessment for Concussion (STAC) application
timeFrame: Day 0-14
measure: Immediate Post-Concussion Assessment and Cognitive Test (ImPACT)
timeFrame: Day 0, Day 10-14,
measure: Vestibular/Ocular Motor Screen (VOMS)
timeFrame: Day 0, Day 10-14,
measure: Modified Balance Error Scoring System (mBESS)
timeFrame: Day 0, Day 10-14,
measure: International Activity Questionnaire (IPAQ)
timeFrame: Day 0, Day 10-14, Day 30, Day 60
measure: Brief Symptom Inventory-18 (BSI-18)
timeFrame: Day 3-5, Day 30, Day 60
measure: Screen Time Assessment
timeFrame: Day 0 - 14
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Danny Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References: