Concussion, Brain Clinical Trial
Official title:
Brock String Therapy for Receded Near Point of Convergence Post Concussion
The purpose of the proposed study is to evaluate the efficacy of Brock String therapy prescribed in the acute stage of concussion recovery can improve clinical outcomes among patients with receded near point of convergence (NPC). Aim 1: Determine if participants receiving the Brock String have more significant improvements in NPC measurements at follow up 7-10 days post injury. Aim 2: Determine if participants receiving the Brock String 1) improve on computerized neurocognitive test scores from initial visit (<48 hours post injury) to follow up visit (7-10 days post injury) compared to control participants, and 2) have reduced recovery time (i.e., days from injury until return to play) compared to control participants.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2024 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 20 Years |
Eligibility | Inclusion Criteria: - Athletes who sustained a concussion during organized sport within past 48 hours - ages 12-20 - at least one NPC measurement >10 centimeters at initial clinic evaluation. Exclusion Criteria: - lack of access to a smart phone to receive text message prompts - vestibular disorder - seizure disorder - history of traumatic brain injury with imaging findings or brain surgery - history of 3+ concussions\ - concussion within the past 6 months - history of developmental or intellectual disability - history of substance abuse - Patients will also be excluded from recruitment if the treating clinician feels the potential participant would be unable to tolerate Brock String therapy due to severe symptoms |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center, Rooney Sports Complex | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Near point of convergence measurement | change in convergence measurement from nose in centimeters | from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury) | |
Secondary | Immediate Post Concussion Assessment and Cognitive Testing (ImPACT | change in test scores based on normative data percentile (range <1-100); for all composite scores, including verbal memory, visual memory, visual motor speed scores, reaction time; better score indicating better performance | from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury) | |
Secondary | concussion recovery duration | recovery time (i.e., days from injury until return to play) | from day of injury until final clinic visit, determined by concussion symptoms resolving and all aspects of testing within normal limits; expected range 7-10 days to up to 6 months post injury |
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