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临床试验/NCT06700252
NCT06700252已完成不适用

Effects of Vestibular Rehabilitation in the Treatment of Dizziness and Balance Disturbances After Concussion

Beth Marschner2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Dynamic Gait Index

研究概览

简要总结

The goal of this clinical trial is to study the effects of including vestibular rehabilitation in the treatment of dizziness and balance disturbances in athletes after concussion. The main questions it aims to answer are:

  • Does inclusion of vestibular rehabilitation treatment have an effect on symptom resolution in those with concussion?
  • Does inclusion of vestibular rehabilitation treatment have an effect on the rate of recovery and return to play after concussion? Researchers will compare vestibular rehabilitation treatment inclusion in concussion treatment to a traditional concussion treatment approach to see if the rate of symptom resolution and return to play are affected by including vestibular rehabilitation for participants who have experienced a concussion within one week of presenting for the study.

Participants will:

  • Be randomly assigned to either receive vestibular rehabilitation included in their concussion treatment or have traditional concussion treatment without vestibular rehabilitation.
  • Complete treatment sessions two times per week for up to four weeks
  • Complete the corresponding home program for the treatment group
  • Complete baseline symptom testing and repeat the symptom testing at study completion for data comparison. Testing includes: Sport Concussion Assessment Tool (SCAT5) including 1) the athlete's background 2) symptom evaluation 3) cognitive screening 4) neurological screening and 5) delayed recall, a Dynamic Gait Index (DGI) including 1) gait on level surface 2) change in gait speed 3) gait with horizontal head turns 4) gait with vertical head turns 5) gait and pivot turn 6) step over obstacle 7) step around obstacle 8) stairs, and a vestibular evaluation including 1) patient history 2) visual assessment 3) vertebral artery clearance 4) cervical spine clearance 5) inner ear assessment 6) brief balance assessment.

详细描述

Nothing further to include that is not entered or uploaded elsewhere in the record

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
None

入排标准

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

入选标准

  • Athlete from a small regional university
  • Experiences a concussion
  • Identified by their certified athletic trainer to have dizziness or balance dysfunctions
  • Referred for initial contact testing and treatment

排除标准

  • Acute spinal cord injury with neurological deficits
  • Epidural and subdural hematoma with known manifestations
  • Acute cervical spine injury

结局指标

主要结局

Dynamic Gait Index

时间窗: Up to 4 weeks

The Dynamic Gait Index (DGI) includes 1) gait on level surface 2) change in gait speed 3) gait with horizontal head turns 4) gait with vertical head turns 5) gait and pivot turn 6) step over obstacle 7) step around obstacle 8) stairs. Each item is scored on a four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function, severe impairment and "3" indicates the highest level of function, normal. There are a total of 24 possible points. The lower the score out of 24, the more balance difficulties.

Sport Concussion Assessment Tool 5

时间窗: Up to 4 weeks

The Sport Concussion Assessment Tool 5 includes: athlete's background, symptom evaluation, cognitive screening, neurological screening, and delayed recall. The symptom scale is from 0 (none) to 6 (severe). There are 22 symptoms with a max score of 132. The higher the score, the more severe. The cognitive screening includes 5 orientation questions, immediate memory using recall of 5 word lists, concentration tasks of backward digit recall starting with three digits and progressing to more if able, recalling the months of the year in reverse and delayed recall at the end of the assessment for the immediate memory word list again. The neurological screening assesses reflexes, pupil response and motor function. Balance is examined using the modified balance error scoring system where more errors indicates more balance issues.

Oculomotor Assessment

时间窗: Up to 4 weeks

Oculomotor Assessment is used to evaluate eye movement and function to determine if movement and function are normal or abnormal. This includes: smooth pursuits, horizontal saccades, vertical saccades, convergence, vestibulo-ocular reflex (VOR), and visual motion sensitivity Test (VMS).

Semicircular Canal Assessment

时间窗: Up to 4 weeks

Semicircular Canal Assessment is used to evaluate how well the inner ear's semicircular canals detect head movement. Tests included in this were the Hallpike-Dix for assessing the posterior canal and the Roll Test for assessing the horizontal canal.

次要结局

未报告次要终点

研究者

发起方
Beth Marschner
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Beth Marschner

Assistant Professor

Minot State University

研究点 (2)

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