跳至主要内容
临床试验/NCT02317107
NCT02317107已完成不适用

A Longitudinal Examination of Dynamic Balance Control, Vestibular/Ocular Motor Function, and Activity Participation Following Concussion

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2015年6月30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
110
试验地点
1
主要终点
Dynamic Balance Control

研究概览

简要总结

Previous research and position statements have outlined the necessity of balance and gait testing in the post-concussion evaluation of athletes. However, many of the currently available balance testing techniques lack objectivity and sensitivity to the effects of concussion. Such balance impairments may exist following concussion due to disruption of vestibular and/or ocular motor systems. However, no clinically feasible tools have been longitudinally examined to detect gait balance control deficits or to investigate how vestibular or motor dysfunction may lead to gait imbalance. Additionally, participation in physical and cognitive activities post-concussion may affect recovery. While limited evidence exists to support this notion, further investigation is necessary to improve clinical management recommendations.

The proposed study will allow for the examination of tools which add value to post-concussion clinical evaluations and study-related outcomes will enhance the understanding of dynamic balance control and vestibular/ocular motor recovery, and their potential for implementation into concussion management protocols.

详细描述

To address study hypotheses, the investigators plan to recruit subjects who have been diagnosed with a concussion by participating sports medicine physicians at the Boston Children's Hospital Sports Concussion Clinic. If patients elect to participate, they will undergo their regularly scheduled clinical examination along with two testing components requiring less than 15 minutes of additional time to complete: an instrumented gait balance assessment, a vestibular-ocular motor screen, and a weekly activity survey. Participants with concussion will be matched with control subjects who meet similar demographic characteristics and report to the clinic for other orthopedic injuries that do not affect brain function, gait, or either lower extremity.

During the assessment, participants will complete a protocol which measures balance control while walking and simultaneously completing a cognitive task, a vestibular-ocular motor ability, and physical and cognitive activity levels. As a need exists to develop protocols which utilize inexpensive, objective, and sensitive measurements to track concussion recovery, this study seeks to incorporate innovative and clinically feasible methods into the clinical examination of concussion.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 12 and 40 years
  • No history of concussion in the past year, and no lifetime history of more than 3 concussions
  • Diagnosed with concussion within the past 21 days (concussion group only)

排除标准

  • Lower extremity deficiency or injury, which may affect normal balance or gait
  • History of permanent memory loss
  • Diagnosis of Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD), learning disability, Down syndrome, or developmental delay

结局指标

主要结局

Dynamic Balance Control

时间窗: 1 year

For balance control measures, the primary data will come from accelerometers placed on specific anatomical landmarks to assess whole body movement. Peak accelerations and velocities of an estimated center-of-mass during gait under single-task and dual-task conditions will identify how divided attention tasks affect whole body balance control.

次要结局

  • Weekly physical and cognitive activity scores(1 year)
  • Vestibular-Ocular Motor Screen(1 year)
  • Temporal/Distance Gait Measurements(1 year)

研究者

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

David R Howell

Research Fellow

Boston Children's Hospital

研究点 (1)

Loading locations...

相似试验