Efficacy of Brock String Therapy Post Concussion

Concussion, Brain Clinical Trial

Official title:

Brock String Therapy for Receded Near Point of Convergence Post Concussion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04076657
• Other study ID #: STUDY19070375
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: University of Pittsburgh
• Contact: Alicia Trbovich, PhD
• Phone: 412-432-3870
• Email: trbovicham[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2024
• Est. primary completion date: April 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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain
• Near Point Convergence

Intervention

Behavioral:
• Brock String Therapy
Oculomotor exercise to improve binocular vision function
• Standard of Care
patient engages in normal behavior to manage vision issues, such as breaks with reading and screen use

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center, Rooney Sports Complex	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

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