NCT03846830已完成不适用
INVENT VPT: Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 4
- 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
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
- 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 Dizziness during the Patrol Exertion Multitask Test (PEMT)(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 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)
- 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)
- 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)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Vestibular Rehabilitation Verses Virtual Reality on Dizziness, Balance and Gait in Subacute StrokeVestibular RehabilitationNCT04771169Riphah International University34
Unknown
不适用
Advances in Vestibular RehabilitationVestibularNCT04144686King's College London48
已完成
不适用
Effectiveness of Vestibular Electrical Stimulation in Vestibular RehabilitationVestibular VertigoVestibular DiseasesVestibular DisorderNCT06563076Ankara City Hospital Bilkent38
已完成
不适用
Effectiveness of Customized Vestibular Rehabilitation (CVR) on balance in adults with Benign Paroxysmal Positional VertigoIdiopathic unilateral posterior canal benign paroxysmal positional vertigofunctional mobility impairementPhysical Medicine / Rehabilitation - PhysiotherapyEar - Other ear disordersACTRN12614000945628Dr Devinder Kaur20
Unknown
不适用
The Effects of Vestibular Rehabilitation Therapy Supported With Virtual Reality in the Elderly Patients With DizzinessDizzinessVestibular RehabilitationVirtual RealityNCT03412708Pamukkale University32