Brock String Therapy for Concussion

Overseen By Alicia Trbovich, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Vestibular disorder, Seizure disorder, 3+ concussions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 7-10 days

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anthony P Kontos, PhD

Principal Investigator

University of Pittsburgh

Alicia Trbovich, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

I am between 12 and 20 years old.

I had a concussion from sports within the last 2 days.

You have at least one measurement of a tumor larger than 10 centimeters when first evaluated at the clinic.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

1 visit (in-person)

Initial Assessment

Participants receive initial assessment and instruction on Brock String therapy or standard of care

<48 hours post injury

1 visit (in-person)

Treatment

Participants perform Brock String therapy at home twice daily or receive standard of care

7-10 days

Follow-up

Participants are monitored for improvements in NPC measurements and neurocognitive test scores

7-10 days post injury

1 visit (in-person)

Extended Follow-up

Participants are monitored for concussion recovery duration until return to play

up to 6 months post injury

Treatment Details

Interventions

• Brock String Therapy

Trial Overview 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.

Participant Groups

Group I: Brock String Experimental Treatment 1 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 Care Active Control 1 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

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+