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临床试验/NCT04268745
NCT04268745已完成不适用

Vestibular Rehabilitation Utilizing Virtual Environments to Train Sensory Integration for Postural Control in a Functional Context

New York University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年8月21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
30
试验地点
2
主要终点
Visual Vertigo Analog Scale (VVAS)

研究概览

简要总结

The specific aims of this pilot project are:

Aim #1: Determine the extent to which sensory integration strategies differ between 28 individuals with unilateral vestibular hypofunction and 28 age-matched peers. Participants' postural sway will be recorded as they experience two levels of moving stars10 and white noise, while standing on the floor or a compliant surface. Our working hypothesis is that patients with vestibular hypofunction utilize substitution strategies such that they will demonstrate greater visual and auditory reliance compared with controls, particularly when somatosensory cues are reduced via the support surface. We will then explore whether these mechanism changes after training.

Aim #2: Develop the protocol and establish the feasibility of a randomized controlled trial (RCT) comparing C.S.I. training to standard vestibular rehabilitation. Following the assessment, the 28 patients will be randomized into standard vestibular rehabilitation vs. C.S.I. training. This pilot study will enable us to test the feasibility of our recruitment, randomization procedures, establish attrition rate, and test the training protocol.

Aim #3: Generate pilot data for sample size calculation for a properly powered RCT. The follow up RCT will test the effect of C.S.I. training on: Visual Vertigo Analog Scale (VVAS), Functional Gait Analysis (primary); balance confidence, overall disability (descriptive). In our preliminary study, 8 patients met the inclusion criteria for the current proposal. Following the C.S.I. training, they had a large effect size of 1.17 on the VVAS. The current study will allow us to identify the between-group effect size for the VVAS and for a functional gait outcome.

详细描述

System: The testing platform runs at 120 frames per second with either HTC Vive or Oculus Rift, on a Windows 10 laptop with 8GB RAM, Intel i7-7820HK CPU, Nvidia GTX 1080 Max-Q GPU, and Bose SoundTrue around-ear headphones II. The software was developed in C# with Unity3D 2018.2.0f1(64-bit) (Unity Technologies, San Francisco, California). The system utilizes SteamVR. Oculus Rift and HTC Vive both operate at 90 Hz refresh rate, 110 degrees field of view, and a high-definition video of 1080x1200 resolution for each eye. The graphics of the subway station, airport terminal building, and subway trains are modeled in Maya and imported to Unity3D. The rest of the 3D objects are modeled in Unity3D. The subway station model and airport model replicate a real subway station in New York City and a real airport terminal in the US. The contents in the system are fully controllable by the user interface (see Figure 3). Three-dimensional sounds were implemented using Wwise middleware and Google Resonance audio plugin. Using the head-tracking data, audio is modulated according to the position of the listener's head. The technology allows for creation of a rich soundscape in all directions around the listener. Audio assets used in the system are divided into two main groups: sound objects and ambiances. Sound objects are attached to the visual objects in the scene and their position is changing accordingly. Sounds include: footsteps, trains, announcements, cars, balls, airplanes, etc. Ambiances are created from original recordings from different locations in New York. These include different background sounds, i.e. sounds of the crowd chatter, distant trains, wind, birds, traffic, and general room tone of each of the spaces. All of the sounds used in the system are assigned to three different intensity levels which relate to the increasing complexity of the soundscape.

Data Collection: The first assessment session will include a well-established postural control assessment that the investigators had translated to a HMD paradigm and added an auditory layer. The protocol will include all possible combinations of the following: 2 levels of visual perturbation (static stars; stars moving in the AP direction, 0.2 Hz, 0.032m); 2 levels of auditory perturbation (quiet room; white noise that cycles from 0 to 1 dB at 0.3Hz), and 2 levels of support surface (floor; memory foam). Each scene will be 60 seconds long, there are 8 combinations, and each will be repeated 3 times for a total of 24 trials. Power spectral density (PSD) of sway in 3 frequency segments will be derived from a laboratory force plate and will serve to explore sensory integration mechanism. Participants will also complete the FGA (primary), VVAS (primary), ABC (descriptive), and DHI (descriptive).

Participants will complete the baseline assessment twice, one week apart, to assure stability of the measures. Following the baseline assessments, participants will be randomized to a C.S.I. experimental group (EG, n = 14) or a standard rehabilitation control group (CG, n = 14). The participants will commence the intervention program within a week of the second assessment. The setting will be a vestibular rehabilitation clinic at the New York Eye and Ear Infirmary of Mount Sinai.

Both groups: Eligible participants will be provided with patient education and a basic home exercise program (gait, balance, no exercises with eyes closed) while they are considering participation in the study.

Program Dose: 8 weeks, 1 visit per week, 30 minutes long EG: Progressive immersive training with the C.S.I. app; Scenes: start from most salient to the patient, eventually do all Duration: start at 60 seconds, increase over time up to 3 minutes per scene Complexity: start minimal, gradually increase up to most complex Tasks: standing with diverse base of support (BOS), head turns (progress with speed, planes); stepping, turning CG: Progressive gait, gaze stability and balance exercises. Gait: walking with head turns, progress with range, speed and planes of head movement; change of walking BOS: wide, normal, tandem Gaze: focus on a target while moving head side to side / up down. Progress with speed, duration, busier background, standing to walking.

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 (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

入选标准

  • Adult patients (18 or older)
  • Clinical diagnosis of chronic (3 months and longer) unilateral peripheral vestibular hypofunction
  • Patients will be included based on the presence of a positive head thrust test, head shaking nystagmus, spontaneous nystagmus, and/or canal paresis > 25% if a caloric test is available.
  • Included patients must present with at least two positive items on the VVAS

排除标准

  • Patients will be excluded for prior vestibular rehab, bilateral or unstable vestibular loss or another neurological condition, active benign paroxysmal positional vertigo, acute orthopaedic injuries, peripheral neuropathy, hearing impairment, or visual impairment not corrected with glasses.

结局指标

主要结局

Visual Vertigo Analog Scale (VVAS)

时间窗: baseline and 8 weeks

The Visual Vertigo Analogue Scale (VVAS) is a self-reported questionnaire where a participant rates their visual vertigo on a 10 cm line in 9 different visually challenging environments. A score of 0 indicates no dizziness. Maximal score is 100 (calculated as the measurement on each item X 9 divided by 10). A higher score indicates worse outcome.

Functional Gait Analysis (FGA)

时间窗: baseline and 8 weeks

A functional test designed to assess individual's ability to perform various motor tasks, such as: walking with eyes closed, walking backwards, climbing stairs. There are 10 items, each is scored by a therapist on a scale of 0 (severe impairment) to 3 (normal). Maximal score is 30. Higher is better.

The Dizziness Handicap Inventory (DHI)

时间窗: baseline and 8 weeks

The DHI has 25 items and each item is scored as 'no', 'sometimes' or 'yes' to evaluate self-perceived disability imposed by dizziness. The minimum score is 0 and the maximum score is 100, a higher score indicates increased perceived disability. The scale is no = 0, sometimes = 2, and yes = 4.

次要结局

  • The Four-Step Square Test(baseline and 8 weeks)
  • Timed-Up and Go(baseline and 8 weeks)
  • The Activities Balance Confidence Scale(baseline and 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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