Efficacy of Brock String Therapy Post Concussion

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.

Study Overview

• Status: Recruiting
• Conditions: Concussion, Brain; Near Point Convergence
• Intervention / Treatment: Behavioral: Brock String Therapy; Behavioral: Standard of Care

Detailed Description

Receded near point of convergence (NPC) is a common oculomotor deficit associated with numerous vision diagnoses, including convergence and accommodative insufficiencies, following sport-related concussion (SRC). Researchers have found associations with worse neurocognitive test scores, higher post-concussion symptom burden, and longer recovery among patients with receded NPC relative to concussion patients with normal NPC. Although oculomotor dysfunction may resolve spontaneously or improves with vision therapy exercises in the post-acute phase of recovery, it is unclear if early intervention can improve recovery outcomes. The Brock String is a cost effective and practical vision therapy exercise for congenital convergence insufficiency (CI), and initial research supports effectiveness with SRC patients who have receded NPC in the subacute phase of recovery (e.g., weeks to months post injury). Early vision therapy intervention may be efficacious in improving recovery times and reduce healthcare costs by eliminating later therapies for chronic deficits.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alicia Trbovich, PhD; Phone Number: 412-432-3870; Email: trbovicham@upmc.edu
• Study Contact Backup: Name: Cynthia Holland, MPH; Phone Number: 412-904-1298; Email: clh197@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15203
      • Recruiting
      • University of Pittsburgh Medical Center, Rooney Sports Complex
      • Contact: Alicia Trbovich, PhD
      • Principal Investigator: Alicia M Trbovich, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brock String; 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; Oculomotor exercise to improve binocular vision function
Active Comparator: Standard of Care; 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; patient engages in normal behavior to manage vision issues, such as breaks with reading and screen use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Alicia Trbovich, PhD, University of Pittsburgh; Principal Investigator: Anthony P Kontos, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: concussion therapy; brock string; sport-concussion; receded near point of convergence
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: STUDY19070375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No