Efficacy of Brock String Therapy Post Concussion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Brock String Therapy for Receded Near Point of Convergence Post Concussion

Conditions
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Concussion, Brain, Near Point Convergence

Intervention / Treatment
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* Behavioral: Brock String Therapy
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brock string, sport-concussion, concussion therapy, receded near point of convergence