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Rest for Concussion (AIM Trial)

N/A
Waitlist Available
Led By Danny Thomas, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of mTBI in the past 72 hours
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, day 10-14, day 30, day 60
Awards & highlights

AIM Trial Summary

This trial will test different recommendations for post-operative activity to find the best ones to recommend to patients.

AIM Trial Eligibility Criteria

Inclusion Criteria

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

AIM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, day 10-14, day 30, day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, day 10-14, day 30, day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pediatric Quality of Life Measures (PedsQL)
Change in Post-Concussion Symptoms Scale (PCSS)
Fitbit Flex 2 Actigraph
Secondary outcome measures
Brief Symptom Inventory-18 (BSI-18)
Immediate Post-Concussion Assessment and Cognitive Test (ImPACT)
International Activity Questionnaire (IPAQ)
+4 more

AIM Trial Design

4Treatment groups
Active Control
Group I: RestActive Control1 Intervention
Discharge instructions focused on 24 - 48 hours of rest then symptom guided activity, Fitbit monitored.
Group II: mHealthActive Control1 Intervention
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.
Group III: ActivityActive Control1 Intervention
Low intensity activity regardless of symptoms using their Fitbit to measure said activity with goals (eg. 10,000 steps/ day.
Group IV: Both Activity and mHealthActive Control2 Interventions
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).

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
604 Previous Clinical Trials
1,162,019 Total Patients Enrolled
Centers for Disease Control and PreventionFED
873 Previous Clinical Trials
22,467,343 Total Patients Enrolled
Danny Thomas, MD4.965 ReviewsPrincipal Investigator - Medical College of Wisconsin
MetroWest Medical Center - Framingham Union Hospital, Tufts Medical Center
Medical School - Medical College of Wisconsin, Doctor of Medicine
Rhode Island Hospital, Residency in Internal Medicine
5Patient Review
They were very pleasant.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I register for this experiment?

"In order to be considered for participation in this trial, prospective participants must have experienced a brain concussion and fall within the ages of 11-24. The current aim is to recruit 388 individuals altogether."

Answered by AI

What is the scope of participants in this clinical research?

"Affirmative. The clinicaltrials.gov database shows that this experiment, which was initially listed on June 11th 2019, is currently enrolling participants. A total of 388 subjects are needed across 3 different sites."

Answered by AI

Is the trial open to participants of all ages, or is there an upper age limit?

"Patients between the ages of 11 and 24 are eligible to partake in this research."

Answered by AI

Is there still an opportunity for participants to join this trial?

"Clinicaltrials.gov shows that this experiment is accepting participants and was initially published on the 11th of June 2019 with an additional update applied on the 11th of May 2022."

Answered by AI

What is the primary aim of this clinical experiment?

"The primary outcome of this trial will be evaluated over a two-week period and is the Post-Concussion Symptoms Scale (PCSS). Secondary outcomes include measurements taken from Vestibular/Ocular Motor Screening, Modified Balance Error Scoring System, and Immediate Post-Concussion Assessment and Cognitive Test. The last assessment takes 30 minutes to complete in addition to PCSS's evaluation."

Answered by AI
~41 spots leftby Mar 2025