Efficacy of Brock String Therapy Post Concussion

Sponsor
University of Pittsburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT04076657
Collaborator
(none)
100
1
2
28.7
3.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brock String Therapy
  • Behavioral: Standard of Care
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Masking Description:
Care provider will not be aware of group assignment; participant will be aware of receiving treatment
Primary Purpose:
Treatment
Official Title:
Brock String Therapy for Receded Near Point of Convergence Post Concussion
Actual Study Start Date :
Nov 9, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Near point of convergence measurement [from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)]

    change in convergence measurement from nose in centimeters

Secondary Outcome Measures

  1. Immediate Post Concussion Assessment and Cognitive Testing (ImPACT [from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)]

    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

  2. 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]

    recovery time (i.e., days from injury until return to play)

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh Medical Center, Rooney Sports Complex Pittsburgh Pennsylvania United States 15203

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alicia Trbovich, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT04076657
Other Study ID Numbers:
  • STUDY19070375
First Posted:
Sep 3, 2019
Last Update Posted:
Feb 4, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alicia Trbovich, Assistant Professor, University of Pittsburgh
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2022