跳至主要内容
临床试验/NCT02640599
NCT02640599已完成不适用

The Effect of Vestibular and Exertion Training on Gait, Balance and Dizziness in Individuals With Concussion

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2014年11月10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
27
试验地点
1
主要终点
Functional Gait Assessment

研究概览

简要总结

Investigators will use a stationary bike protocol to investigate whether patients with post concussion syndrome benefit from adding exertion training to a vestibular rehabilitation program.

Investigators examine the effect of aerobic exercise testing and training on individuals with concussion who are currently experiencing symptoms and examine the effect of aerobic exercise in combination with traditional vestibular rehabilitation.

详细描述

This is a randomized controlled single blind pilot study testing the hypothesis that the combination of aerobic exercise plus vestibular rehabilitation will result in greater reduction of symptoms of dizziness and imbalance compared to vestibular rehabilitation alone.

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 (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of concussion >14 days, <6 months
  • One or more of the following symptoms after most recent head injury: headache, dizziness, fatigue, irritability, insomnia, concentration or memory difficulty)
  • Age range - 18-70
  • Access to stationary bicycle
  • Ability to read and write sixth grade English

排除标准

  • Inability to participate in aerobic exercise for any reason
  • Pre-existing or current neurological or autonomic disease including persistent symptoms form previous concussion
  • Major depressive disorder
  • Increased cardiac risk
  • Currently taking, Beta Blockers, or Anticonvulsants

结局指标

主要结局

Functional Gait Assessment

时间窗: change in gait from initial evaluation to week 6

10-item test that measures gait with a narrow base of support, gait with eyes closed, ambulating backwards, as well as ambulation with head turns. The maximum score is 30. Higher scores indicate better performance.

Changes in Visual Analog Scale (VAS) of Dizziness Score

时间窗: change in VAS of Dizziness Score from initial evaluation to week 6

Changes in Dizziness Handicap Inventory (DHI) Score

时间窗: change in DHI Score from initial evaluation to week 6

25-item scale that addresses the functional, emotional, and physical components of dizziness. Higher scores indicate greater handicap (range, 0 - 100)

Changes in balance Error Scoring System (BESS) score

时间窗: change in (BESS) Score from initial evaluation to week 6

requires participants to maintain balance with eyes closed with their hands on their iliac crests under six different surface conditions. Number of errors in each trial are added together to obtain a total score (out of 60).

Changes in Sport Concussion Assessment Tool (SCAT-3) Score

时间窗: change in (SCAT-3) from initial evaluation to week 6

22 item postconcussion symptom scale using a seven point Likert rating. This scale provides an assessment of symptoms endorsed, along with a severity score. The maximum symptom score is 22, the symptom severity score is obtained by summing the rated symptom score for each symptom (maximum score 132).

Change in the number of symptoms on checklist of the Sports Concussion Assessment Tool

时间窗: change in symptoms from initial evaluation to week 6

Changes in Dynamic Visual Acuity (DVA) Score

时间窗: change in DVA Score from initial evaluation to week 6

instrumented, objective assessment of vestibulo-ocular reflex (VOR) function in response to head movement. The Dynamic Visual Acuity Test assesses visual acuity during head movement relative to baseline static visual acuity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验