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Brock String Therapy for Concussion
N/A
Recruiting
Led By Anthony P Kontos, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 12-20
ages 12-20
Must not have
History of traumatic brain injury with imaging findings or brain surgery
Vestibular disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)
Awards & highlights
No Placebo-Only Group
Summary
This trial will help determine if Brock String therapy can improve clinical outcomes for people with concussion.
Who is the study for?
This trial is for athletes aged 12-20 who have had a concussion during organized sports in the last 48 hours and show a receded near point of convergence (NPC) greater than 10 centimeters. It's not suitable for those without smartphone access, with severe symptoms, recent concussions, vestibular or seizure disorders, significant brain injury history, intellectual disabilities, or substance abuse issues.
What is being tested?
The study tests if Brock String therapy helps improve NPC measurements and cognitive test scores post-concussion better than standard care. It also looks at whether this therapy can shorten the time it takes for injured athletes to return to play.
What are the potential side effects?
Brock String therapy is generally considered low-risk; however, individuals with severe concussion symptoms may not tolerate it well. The trial excludes these participants to minimize potential discomfort or adverse effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 20 years old.
Select...
I am between 12 and 20 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a brain injury or surgery confirmed by scans.
Select...
I have a balance disorder.
Select...
I have a seizure disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Near point of convergence measurement
Secondary study objectives
Immediate Post Concussion Assessment and Cognitive Testing (ImPACT
concussion recovery duration
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Brock StringExperimental Treatment1 Intervention
Participants will receive instruction on Brock String therapy after first clinic visit (\<48 hours post) injury, and will complete home therapy exercise twice daily
Group II: Standard of CareActive Control1 Intervention
Participants will receive standard of care (i.e., no Brock String therapy within the first week post injury) but will be informed they will receive any therapy deemed necessary at follow up visit 7-10 days post injury, consistent with standard of care
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,573 Total Patients Enrolled
Anthony P Kontos, PhDPrincipal InvestigatorUniversity of Pittsburgh
4 Previous Clinical Trials
237 Total Patients Enrolled
Alicia Trbovich, PhDPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a brain injury or surgery confirmed by scans.My doctor thinks I can't handle Brock String therapy because my symptoms are too severe.You don't have a smartphone to receive text messages.I am between 12 and 20 years old.I had a concussion from sports within the last 2 days.You have had a concussion in the last 6 months.I have a balance disorder.I have a seizure disorder.You have had three or more concussions in the past.You have a history of a condition that affects your learning or thinking ability.You have a history of using drugs or alcohol excessively.You have at least one measurement of a tumor larger than 10 centimeters when first evaluated at the clinic.I am between 12 and 20 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Brock String
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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