增量速度误差作为前庭康复治疗的新方法（INVENT VPT）试验：一项随机对照交叉试验的研究方案。

Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) Trial: study protocol for a randomized controlled crossover trial.

机构信息

Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA.

Johns Hopkins University School of Medicine, 601 N. Caroline Street, Baltimore, MD, 21287, USA.

出版信息

Trials. 2021 Dec 11;22(1):908. doi: 10.1186/s13063-021-05876-4.

DOI:10.1186/s13063-021-05876-4

PMID:34895314

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8666079/

Abstract

BACKGROUND

A clinical pattern of damage to the auditory, visual, and vestibular sensorimotor systems, known as multi-sensory impairment, affects roughly 2% of the US population each year. Within the population of US military service members exposed to mild traumatic brain injury (mTBI), 15-44% will develop multi-sensory impairment following a mild traumatic brain injury. In the US civilian population, multi-sensory impairment-related symptoms are also a common sequela of damage to the vestibular system and affect ~ 300-500/100,000 population. Vestibular rehabilitation is recognized as a critical component of the management of multi-sensory impairment. Unfortunately, the current clinical practice guidelines for the delivery of vestibular rehabilitation are not evidence-based and primarily rely on expert opinion. The focus of this trial is gaze stability training, which represents the unique component of vestibular rehabilitation. The aim of the Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) trial is to assess the efficacy of a non-invasive, incremental vestibular adaptation training device for normalizing the response of the vestibulo-ocular reflex.

METHODS

The INVENT VPT Trial is a multi-center randomized controlled crossover trial in which military service members with mTBI and civilian patients with vestibular hypofunction are randomized to begin traditional vestibular rehabilitation or incremental vestibular adaptation and then cross over to the alternate intervention after a prescribed washout period. Vestibulo-ocular reflex function and other functional outcomes are measured to identify the best means to improve the delivery of vestibular rehabilitation. We incorporate ecologically valid outcome measures that address the common symptoms experienced in those with vestibular pathology and multi-sensory impairment.

DISCUSSION

The INVENT VPT Trial will directly impact the health care delivery of vestibular rehabilitation in patients suffering from multi-sensory impairment in three critical ways: (1) compare optimized traditional methods of vestibular rehabilitation to a novel device that is hypothesized to improve vestibulo-ocular reflex performance, (2) isolate the ideal dosing of vestibular rehabilitation considering patient burden and compliance rates, and (3) examine whether recovery of the vestibulo-ocular reflex can be predicted in participants with vestibular symptoms.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03846830 . Registered on 20 February 2019.

摘要

背景

一种涉及听觉、视觉和前庭感觉运动系统损伤的临床模式，称为多感官障碍，每年影响大约 2%的美国人口。在美国军事人员中，暴露于轻度创伤性脑损伤（mTBI）的人群中，15-44%在轻度创伤性脑损伤后会出现多感官障碍。在美国平民中，与多感官障碍相关的症状也是前庭系统损伤的常见后遗症，影响~300-500/100,000 人口。前庭康复被认为是多感官障碍管理的重要组成部分。不幸的是，目前前庭康复的临床实践指南不是基于证据的，主要依赖于专家意见。本试验的重点是凝视稳定性训练，这是前庭康复的独特组成部分。增量速度误差作为前庭康复的新治疗方法（INVENT VPT）试验的目的是评估一种非侵入性、递增性前庭适应训练设备的疗效，以正常化前庭眼反射的反应。

方法

INVENT VPT 试验是一项多中心随机对照交叉试验，其中患有 mTBI 的军事人员和患有前庭功能低下的平民患者被随机分配接受传统前庭康复或递增性前庭适应治疗，然后在规定的洗脱期后交叉接受另一种干预措施。测量前庭眼反射功能和其他功能结果，以确定改善前庭康复效果的最佳方法。我们采用生态有效测量方法，解决前庭病理和多感官障碍患者常见的症状。