Efficacy of Brock String Therapy Post Concussion
Primary Purpose
Concussion, Brain, Near Point Convergence
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brock String Therapy
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Concussion, Brain focused on measuring brock string, sport-concussion, concussion therapy, receded near point of convergence
Eligibility Criteria
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
Sites / Locations
- University of Pittsburgh Medical Center, Rooney Sports ComplexRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Brock String
Standard of Care
Arm Description
Participants will receive instruction on Brock String therapy after first clinic visit (<48 hours post) injury, and will complete home therapy exercise twice daily
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
Outcomes
Primary Outcome Measures
Near point of convergence measurement
change in convergence measurement from nose in centimeters
Secondary Outcome Measures
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
concussion recovery duration
recovery time (i.e., days from injury until return to play)
Full Information
NCT ID
NCT04076657
First Posted
August 27, 2019
Last Updated
January 17, 2023
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT04076657
Brief Title
Efficacy of Brock String Therapy Post Concussion
Official Title
Brock String Therapy for Receded Near Point of Convergence Post Concussion
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain, Near Point Convergence
Keywords
brock string, sport-concussion, concussion therapy, receded near point of convergence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
Care provider will not be aware of group assignment; participant will be aware of receiving treatment
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brock String
Arm Type
Experimental
Arm Description
Participants will receive instruction on Brock String therapy after first clinic visit (<48 hours post) injury, and will complete home therapy exercise twice daily
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Brock String Therapy
Intervention Description
Oculomotor exercise to improve binocular vision function
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
patient engages in normal behavior to manage vision issues, such as breaks with reading and screen use
Primary Outcome Measure Information:
Title
Near point of convergence measurement
Description
change in convergence measurement from nose in centimeters
Time Frame
from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)
Secondary Outcome Measure Information:
Title
Immediate Post Concussion Assessment and Cognitive Testing (ImPACT
Description
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
Time Frame
from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)
Title
concussion recovery duration
Description
recovery time (i.e., days from injury until return to play)
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Trbovich, PhD
Phone
412-432-3870
Email
trbovicham@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Holland, MPH
Phone
412-904-1298
Email
CLH197@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Trbovich, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony P Kontos, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center, Rooney Sports Complex
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Trbovich, PhD
First Name & Middle Initial & Last Name & Degree
Alicia M Trbovich, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Brock String Therapy Post Concussion
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