Towards Comparative Effectiveness in Military Vestibular Rehabilitation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change in Dizziness Handicap Inventory (DHI) score
研究概览
简要总结
To prospectively evaluate the tools, environment and resources to compare the effectiveness of two different standard of care vestibular rehabilitation approaches in a military cohort with post-concussive vestibular symptoms.
详细描述
Aim 1. To prospectively evaluate the reliability of a series of diagnostic and outcome assessment tools in a military cohort with post-concussive vestibular symptoms; these to include the Dizziness Handicap Inventory (DHI), Activities-Specific Balance Confidence Scale (ABC), the Computerized Dynamic Posturography (CDP) and the Neuro-Otologic Test System (NOTC).
Hypothesis 1. Active military personnel consist of physically high functioning individuals in whom standard diagnostic and outcome assessment tools may fail to target variations in performance. The investigators believe that active military personnel score different than general populations in standard diagnostic and outcome assessment tools.
Endpoint 1. The investigators will compare the DHI, ABC, CDP and NOTC results obtained in this study with historical data from the studies supporting the validation of each of the individual assessment tools.
Aim 2. To assess the concept of 'clinically meaningful change' as it relates to dizziness specific to a military cohort with post-concussive vestibular symptoms.
Hypothesis 2. Because of the differences in physical characteristics and performance demands between active duty military personnel and the general population, it is difficult to define if changes in diagnostic and outcome assessment evaluations in the military population reflect worsening or progression of symptoms at the same rate and magnitude observed in the general population.
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 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active Duty Service Member
- •Referral to Warrior Recovery Center
- •Need of treatment for gaze stabilization, static standing, balance, dynamic standing balance, gait, motion sensitivity, modified center of gravity, and/or work-related functional task training; determined by physical therapist
- •Dizziness as identified by a score of 16 - 64 on DHI
- •Personal history of Mild-Traumatic TBI occurring between 4 weeks and 5 years from the Pre-Treatment PT Evaluation Visit
- •Fluency in English
排除标准
- •Participation in a concurrent interventional trial
- •History of Severe TBI
- •Inability to participate in treatment visits or any of the research activities
- •Any vestibular dysfunction that cannot be treated with a generalized treatment plan (e.g. benign paroxysmal positional vertigo, acute vestibular infection) as defined by PT discretion
- •Any unstable and/or chronic medical or psychiatric condition that could confound the results of the study and/or place the participant at risk
结局指标
主要结局
Change in Dizziness Handicap Inventory (DHI) score
时间窗: Baseline and 2 weeks after final treatment visit
Self reported perception of handicap related to dizziness. 25 questions. Each item is scored 0 - 4 (0 = no, 2 = sometimes, 4 = always), yielding a total score between 0 (no perceived disability) and 100 (maximum perceived disability). Subscales related to certain questions are describes as physical, emotional and functional disabilities.
次要结局
- Change in Equilibrium Score on Sensory Organization Test (SOT)(Baseline and 2 weeks after final treatment visit)
- Change in Equilibrium Score Ratio (SOT and Horizontal HS-SOT)(Baseline and 2 weeks after final treatment visit)
- Change in Neuro-Otologic Testing(Baseline and 2 weeks after final treatment visit)
- Change in Activities-specific Balance Confidence (ABC) Scale(Baseline and 2 weeks after final treatment visit)
- Change in Composite Equilibrium Score on Sensory Organization Test (SOT)(Baseline and 2 weeks after final treatment visit)
- Change in Equilibrium Score on Horizontal Head-Shake Sensory Organization Test (HS-SOT)(Baseline and 2 weeks after final treatment visit)
- Change in logMAR (Visual Acuity) during horizontal head movement (Dynamic Visual Acuity)(Baseline and 2 weeks after final treatment visit)
- Change in logMAR (Visual Acuity) during vertical head movement (Dynamic Visual Acuity)(Baseline and 2 weeks after final treatment visit)