跳至主要内容
临床试验/NCT04076657
NCT04076657已完成不适用

Brock String Therapy for Receded Near Point of Convergence Post Concussion

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Near point of convergence measurement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Care provider will not be aware of group assignment; participant will be aware of receiving treatment

入排标准

年龄范围
12 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Near point of convergence measurement

时间窗: from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)

change in convergence measurement from nose in centimeters

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alicia Trbovich

Assistant Professor

University of Pittsburgh

研究点 (2)

Loading locations...

相似试验