Status:
COMPLETED
Concussion Pen Screening Tool
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Fixation, Ocular
Brain Concussion
Eligibility:
All Genders
11-18 years
Phase:
NA
Brief Summary
To compare the use of the Concussion Pen to current clinical care practice. This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All...
Detailed Description
This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion and will also be e...
Eligibility Criteria
Inclusion
- Inclusion Criteria for both control and study cohorts, unless stated otherwise below
- Patients cognitively 11 to 18 years of age.
- Patients undergoing evaluation for concussion in Children's Mercy (CM) clinics for concussion population.
- Patients with a history of concussion at any previous point in time (no time limits to this date).
- Patients with no history of concussion and being seen at CM PT/OT for other diagnoses for control population.
- Patients able to give verbal assent or consent (dependent on patient cognitive age), and Legally Authorized Representatives (LAR)s able to give verbal parental permission.
- English-speaking families.
Exclusion
- Patients not within the inclusion criteria as outlined above.
- Patients with congenital vestibular dysfunction will not be included.
- Patients diagnosed with dyslexia or Attention Deficit Hyperactive Disorder (ADHD) will not be included.
- Non-English-speaking families.
- Wards of the State will not be approached for this study.
- Patients with a previous diagnosis of strabismus or convergence insufficiency will be excluded.
Key Trial Info
Start Date :
July 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05432752
Start Date
July 28 2022
End Date
January 25 2023
Last Update
March 2 2023
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108