NCT04076657

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 9, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2025

Completed
Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

4.4 years

First QC Date

August 27, 2019

Last Update Submit

June 2, 2025

Conditions

Keywords

brock stringsport-concussionconcussion therapyreceded near point of convergence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Immediate Post Concussion Assessment and Cognitive Testing (ImPACT

    from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)

  • concussion recovery duration

    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

Study Arms (2)

Brock String

EXPERIMENTAL

Participants will receive instruction on Brock String therapy after first clinic visit (\<48 hours post) injury, and will complete home therapy exercise twice daily

Behavioral: Brock String Therapy

Standard of Care

ACTIVE COMPARATOR

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

Behavioral: Standard of Care

Interventions

Oculomotor exercise to improve binocular vision function

Brock String

patient engages in normal behavior to manage vision issues, such as breaks with reading and screen use

Standard of Care

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center, Rooney Sports Complex

Pittsburgh, Pennsylvania, 15203, United States

Location

Related Publications (1)

  • Trbovich AM, Zynda AJ, Togashi T, Burley C, Mucha A, Collins MW, Kontos AP. Randomized Controlled Trial of Brock String Vision Therapy for Receded Near Point of Convergence Following Concussion. J Neurotrauma. 2025 Oct;42(19-20):1708-1718. doi: 10.1177/08977151251359960. Epub 2025 Sep 16.

MeSH Terms

Conditions

Brain Concussion

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Alicia Trbovich, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
  • Anthony P Kontos, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Care provider will not be aware of group assignment; participant will be aware of receiving treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 27, 2019

First Posted

September 3, 2019

Study Start

November 9, 2020

Primary Completion

March 19, 2025

Study Completion

March 19, 2025

Last Updated

June 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations