Active Injury Management (AIM) After Pediatric Concussion

NCT03869970 | Completed

• 1 other identifier: PRO00033221
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Brain Concussion

Keywords

Concussion

Outcome Measures

Primary Outcomes (3)

• Change in Post-Concussion Symptoms Scale (PCSS)

  Post-concussive symptoms at 14 days will be assessed using the Post-Concussion Symptom Scale (PCSS). We chose the 22-item PCSS as it is commonly used and would ensure consistency in longitudinal comparisons. The PI has validated PCSS administration via phone. The PCSS comprises 22 self-reported symptoms (e.g., dizziness headache) rated on a scale from 0 (none) to 6 (severe). PCSS score of ≤ 7 will be defined as symptom recovery. The PCSS takes 5 min to complete.

  Day 0, Day 10-14

• Change in Pediatric Quality of Life Measures (PedsQL)

  We will assess health-related quality of life at 14 days using the PedsQL, a validated tool that has been used in healthy children and adolescents and those with acute and chronic health conditions. PedsQL has been demonstrated to show differences between subjects with persistent symptoms and those without up to 12 weeks post-concussion. The PedsQL measures have reliability and validity in assessing and comparing health-related quality of life scores between groups. They are agespecific and can be administered to parents and children and have been used to assess functional outcomes over time. The inventory includes 23 items rated from 0 (never) to 4 (almost always) and takes less than 5 min to complete.

  Day 0, Day 10-14,

• Fitbit Flex 2 Actigraph

  The Fitbit Flex 2 Actigraph will be distributed from the ED for all subjects in the study. Fitbit Actigraphs have been utilized in over 300 published studies. The Fitbit Flex 2 device to be worn by all subjects will provide objective activity metrics including measures of physical activity (e.g., number of steps per day, active minutes, distance traveled) and sleep (e.g., time to fall asleep, time sleeping, restless time). The Fitbit Flex 2 has a up to 5 days of battery life (device reminds subjects when battery life is low). The device 5 LEDs can be utilized to remind subjects to move, remind of current step goals, and celebrate when the goal is met. These features will be activated for subjects in the ACTIVITY groups. These data will be extracted directly from each device through Fitbit's API (Application Programming Interface. Allows devices to communicate with other select devices) system. These data will be collected in the first 14 days postinjury.

  Day 0-14

Secondary Outcomes (7)

• Symptom Tracking Assessment for Concussion (STAC) application

  Day 0-14

• Immediate Post-Concussion Assessment and Cognitive Test (ImPACT)

  Day 0, Day 10-14,

• Vestibular/Ocular Motor Screen (VOMS)

  Day 0, Day 10-14,

• Modified Balance Error Scoring System (mBESS)

  Day 0, Day 10-14,

• International Activity Questionnaire (IPAQ)

  Day 0, Day 10-14, Day 30, Day 60

Study Arms (4)

Rest

ACTIVE COMPARATOR

Discharge instructions focused on 24 - 48 hours of rest then symptom guided activity, Fitbit monitored.

Behavioral: REST

mHealth

ACTIVE COMPARATOR

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.

Behavioral: mHEALTH

Activity

ACTIVE COMPARATOR

Low intensity activity regardless of symptoms using their Fitbit to measure said activity with goals (eg. 10,000 steps/ day.

Behavioral: ACTIVITY

Both Activity and mHealth

ACTIVE COMPARATOR

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).

Behavioral: ACTIVITY; Behavioral: mHEALTH

Interventions

REST BEHAVIORAL

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

Rest

ACTIVITY BEHAVIORAL

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.

Activity; Both Activity and mHealth

mHEALTH BEHAVIORAL

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.

Both Activity and mHealth; mHealth

Eligibility Criteria

• Age: 11 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of mTBI in the past 72 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• 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.

  PMID: 40254050 DERIVED

• 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.

  PMID: 39489284 DERIVED

MeSH Terms

Conditions

Brain Concussion

Interventions

Exercise; Telemedicine

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Danny Thomas, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Pediatric Emergency Medicine

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 11, 2019
• Study Start: June 11, 2019
• Primary Completion: June 22, 2023
• Study Completion: August 11, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Throughout the described life of the study indicated earlier.
• Access Criteria: Upon request.

Locations

US (2)