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临床试验/NCT05956223
NCT05956223已完成不适用

The Development of a System for Measurement of Tremor

The Bionics Institute of Australia2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2023年11月30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
43
试验地点
2
主要终点
1. To quantify Essential Tremor and dystonia using a measurement system

研究概览

简要总结

The goal of this clinical trial is to develop a system which can be used to measure movements in people with Essential Tremor (with or without dystonia).

The main questions it aims to answer are:

  • Can individuals with Essential Tremor be distinguished from individuals without tremor using Virtual Reality (VR)
  • Can the current Essential Tremor Assessment Scale (the TETRAS) be reproduced in VR
  • Can Essential Tremor be quantified using a measurement system
  • Can Dystonia be quantified using a measurement system. Participants will don the equipment used to measure their tremor and replicate a series of standardized movements to measure their tremor, in and out of the VR platform. The assessment will take no longer than an hour.

详细描述

This study aims to develop a way of objectively measuring the neurological disorders, Essential Tremor (ET) and dystonia. These conditions can affect the upper and lower limbs, head, voice, face and trunk. ET and dystonia can be difficult to assess and treat, particularly if severe, and therapies are limited.

Currently the severity of these conditions is formally assessed by clinician rated scales such as the Essential Tremor Rating Assessment Scale (TETRAS) which is biased towards the upper limbs, requires training and is not objective. There is a need for a more precise, less variable measure of tremor that can used easily be non-expert clinicians. This study questions whether it is possible to quantify ET and dystonia using a measurement system in a virtual reality (VR) environment.

Data will be collected from measurement sensors embedded in the VR environment from healthy control participants, and those with ET with and without dystonia. Participants will be placed in a VR environment and instructed to perform the TETRAS. This will help to develop an algorithm which can measure ET severity using machine learning. It is expected that the algorithm will provide a better assessment of ET and dystonia than the TETRAS. This study may pave the way towards the development of simpler devices to which the algorithm can be applied.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

1. To quantify Essential Tremor and dystonia using a measurement system

时间窗: At enrolment. This study is a single assessment conducted at one time point.

Using commercially available Virtual Reality (VR) equipment and a commercially available Inertial Measurement Unit (IMU), the presence of the tremor and dystonia in participants with Essential Tremor will be measured and their severity rated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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