Clinical trial NCT04076657: Efficacy of Brock String Therapy Post Concussion
Official title: Brock String Therapy for Receded Near Point of Convergence Post Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Near Point Convergence
Keywords: brock string
sport-concussion
concussion therapy
receded near point of convergence
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Near point of convergence measurement
timeFrame: from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)
Secondary outcomes:
measure: Immediate Post Concussion Assessment and Cognitive Testing (ImPACT
timeFrame: from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)
measure: concussion recovery duration
timeFrame: 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
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, Rooney Sports Complex
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Alicia Trbovich, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Anthony P Kontos, PhD
role: PRINCIPAL_INVESTIGATOR
References: