INVENT VPT: Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in vestibulo-ocular reflex (VOR) Gain
研究概览
简要总结
The objective for this study is to compare outcome measures from vestibular rehabilitation (VPT) delivered in a traditional method against a new device Incremental Velocity Error (IVE) that improves physiologic performance of the vestibulo-ocular reflex. Participants include active duty service members with mild traumatic brain injury (mTBI) and civilians with peripheral vestibular hypofunction. The investigators will use a clinical trial cross-over design with randomization to either the control (VPT) or experimental (IVE) group and measure vestibulo-ocular reflex function as well as subjective and functional outcomes in order to investigate the best means to improve delivery of vestibular rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 18 years old
- •Service members with mTBI and civilian patients with vestibular hypofunction, both of which reports vestibular symptoms (i.e. dizziness, imbalance).
排除标准
- •Any subjects with a self-reported history of significant ophthalmic, neuromuscular, cardiovascular (except hypertension), renal/electrolyte and psychiatric disorders
- •Those with uncontrolled severe hypertension (systolic BP of >200 mm Hg and/or a diastolic BP of > 110 mmHg at rest)
- •Those with a recent history of alcohol and/or drug abuse within the past 6 months
研究组 & 干预措施
IVE/VPT 6 week Crossover
Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 5 weeks, 6 weeks washout, and then crossover into the other group for a final 5 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout each of the 5 weeks epochs of training.
干预措施: Incremental Velocity Error (IVE) (Device)
IVE/VPT 6 week Crossover
Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 5 weeks, 6 weeks washout, and then crossover into the other group for a final 5 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout each of the 5 weeks epochs of training.
干预措施: Traditional Vestibular Rehabilitation (VPT) (Behavioral)
IVE/VPT 3 week Crossover
Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training will not start until the washout period.
干预措施: Incremental Velocity Error (IVE) (Device)
IVE/VPT 3 week Crossover
Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training will not start until the washout period.
干预措施: Traditional Vestibular Rehabilitation (VPT) (Behavioral)
IVE/VPT 3 week crossover
Subjects will randomly be placed in one of two groups (IVE or VPT) involving every other day exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout the 3 weeks of exercise.
干预措施: Incremental Velocity Error (IVE) (Device)
IVE/VPT 3 week crossover
Subjects will randomly be placed in one of two groups (IVE or VPT) involving every other day exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout the 3 weeks of exercise.
干预措施: Traditional Vestibular Rehabilitation (VPT) (Behavioral)
结局指标
主要结局
Change in vestibulo-ocular reflex (VOR) Gain
时间窗: Weekly, up to 6 months
A ratio of eye/head velocity measured using a small video camera attached to a lightweight headband. This is an off-the-shelf device commonly used in clinic. Scores typically vary between 0 and 1.2 and normal ranges are between 0.8 and 1.2.
次要结局
- Change in visual acuity during the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)
- Change in 5 min heart rate during the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)
- Baseline oculomotor function assessed with Videonystagmography/Electronystagmography (VNG/ENG)(At first visit, up to 30 minutes.)
- Change in Dizziness Handicap Inventory(Every other week, up to 6 months)
- Change in Time ( in seconds) Standing during the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)(Every other week, up to 6 months)
- Change in the tandem walk test assessed by number of steps taken(Every other week, up to 6 months)
- Change in the time to complete the Timed Up and Go (TUG) Contra Turn.(Every other week, up to 6 months)
- Baseline vestibular function assessed with Vestibular Evoked Myogenic Potential (VEMP)(At first visit, up to 20 minutes.)
- Change in Neurobehavioral Symptom Inventory (NSI)(Every other week, up to 6 months)
- Change in Dynamic Visual Acuity (DVA)(Every other week, up to 6 months)
- Pre Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)
- Change in Headache during the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)
- Baseline vestibular function assessed with Videonystagmography/Electronystagmography (VNG/ENG)(At first visit, up to 30 minutes.)
- Change in Activity Specific Balance Confidence scale (ABC)(Every other week, up to 6 months)
- Change in Patient Global Impression of Change (PGIC)(Every other week, up to 6 months)
- Change in Area (in degrees) of Sway during the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)(Every other week, up to 6 months)
- Change in Fogginess (mental) during the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)
- Change in Dizziness during the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)
- Change in Nausea during the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)
- Baseline vestibular function assessed with Rotary Chair(At first visit, up to 40 minutes.)
- Change in the time to complete the Timed Up and Go (TUG) Ipsi Turn.(Every other week, up to 6 months)
- Change in Mean Reaction Time during the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)
- Pre heart rate during the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)
- Post (video) heart rate during the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)
- Final heart rate during the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)
- 5 min Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)
- Change in the Functional Gait Assessment (FGA)(Every other week, up to 6 months)
- Post (video) Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)(Every other week, up to 6 months)