Status:
COMPLETED
ReCoUPS: Post-Concussion Patient Reports
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Brain Concussion
Head Injury
Eligibility:
All Genders
13-64 years
Phase:
NA
Brief Summary
Physical and cognitive rest are recommended as treatment for concussion, but debate persists about the utility of this recommendation for patients recovering from concussion. In addition, patient adhe...
Detailed Description
Although physical and cognitive rest are recommended as the hallmark treatment for concussion, debate persists about the utility of this recommendation for patients recovering from a concussion. In ad...
Eligibility Criteria
Inclusion
- Males or females ages 13 to 64 years.
- Presents with head injury concerning for concussion in line with criteria specified in the most recent Consensus Statement on Concussion in Sport, defined as head trauma with neurologic impairment, including, but not limited to somatic (eg, headache), cognitive (eg, feeling like in a fog) and/or emotional symptoms (eg, lability) symptoms.
- Within approximately 5 days of injury.
- Ownership of a smartphone to report symptoms and activities.
- Speak English.
- Informed consent or parental/guardian permission and child assent for those under 18 years of age.
Exclusion
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Key Trial Info
Start Date :
March 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04499937
Start Date
March 3 2019
End Date
February 5 2021
Last Update
March 8 2024
Active Locations (2)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
2
The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104