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临床试验/NCT02945605
NCT02945605终止不适用

Effects of Early Vestibular Rehabilitation Compared to Standard Care in Patients With Dizziness and Balance Disorders After Sport and Recreation Concussion

University of Michigan2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2017年3月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
2
主要终点
Change in Sports Concussion Assessment Tool (SCATIII) Symptom Inventory

研究概览

简要总结

This study examines the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems) and improving the timeline to achieve medical clearance to return to activities such as sports and work activities. Half of the participants will receive early vestibular rehabilitation added to standard of care, while the other half will receive standard of care only.

详细描述

As awareness of concussion and the numbers of reported concussions increase every year in the last few years, so does the need for more effective treatment strategies. Concussions can lead to a variety of symptoms that may last from days to weeks after injury.[1] Dizziness and vestibular impairments are prevalent in up to 81% of patients after concussion.[2,3] Additionally, dizziness and vestibular impairments are predictive of prolonged recovery times after concussion.[4] Although there are few studies suggesting that vestibular rehabilitation after concussion is promising,[5,6] there continues to be a void in well-controlled studies verifying that vestibular rehabilitation can be used to treat patients with dizziness and balance disorders after concussion. Due to the lack of controlled studies and current practice patterns, patients with concussions are not seen for physical therapy until weeks or months after their injury. The purpose of this study is to examine the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems), and improving the timeline to achieve medical clearance to return to activities such as sports and work activities, when compared to STANDARD care. The findings of this study are expected to provide medical and sports related professionals with appropriate concussion treatment strategies and improve outcomes of patients suffering from concussion.

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
Single (Investigator)

入排标准

年龄范围
14 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Dizziness or balance problems within 10 days of concussion

排除标准

  • 未提供

研究组 & 干预措施

Early Vestibular Rehabilitation

Experimental

Participants in this group will receive a customized vestibular rehabilitation program designed and implemented by a vestibular physical therapist. The vestibular physical therapy must be initiated within 72 hours after randomization. Participants in this group will continue to receive standard of care treatment as directed by their physician.

干预措施: Early Vestibular Rehabilitation (Other)

Early Vestibular Rehabilitation

Experimental

Participants in this group will receive a customized vestibular rehabilitation program designed and implemented by a vestibular physical therapist. The vestibular physical therapy must be initiated within 72 hours after randomization. Participants in this group will continue to receive standard of care treatment as directed by their physician.

干预措施: Standard of Care (Other)

Standard of Care

Active Comparator

Participants in this group will receive standard care as directed by their physician.

干预措施: Standard of Care (Other)

结局指标

主要结局

Change in Sports Concussion Assessment Tool (SCATIII) Symptom Inventory

时间窗: At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)

The change is calculated by subtracting the score obtained at a designated time point from the initial score.

次要结局

  • Change in Dizziness Handicap Inventory (DHI)(At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first))
  • Change in Vestibular Ocular Motor Screening (VOMS)(Up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
  • Change in Functional Gait Assessment (FGA)(Up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
  • Change in Original and Cognitive Timed Up & Go (TUG)(Up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
  • Global Rating of Change (GRC)(At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first))
  • Time until medical clearance to return to sports/activities(The number of days between concussion and the day when a physician provided full clearance to return to sport/activities (retrieved from medical record) up to 52 weeks from concussion date. [the date of clearance - the concussion date])
  • Change in Original and dual task Balance Error Scoring System (BESS)(Up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
  • Change in Limits of Stability (LOS) Test(Up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
  • Change in Clinical Dynamic Visual Acuity(Up to 5 weeks, or after full resolution of symptoms, whichever occurs first)

研究者

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

Bara Alsalaheen, PT, Ph.D.

Assistant Professor

University of Michigan

研究点 (2)

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