Virtual Reality in Functional Movement Disorder
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Virtual reality motor task.
- Кому может быть актуально
- Состояния в реестре: Functional Movement Disorder. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австрия
- Следующий шаг
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Официальное название
The Effect of Virtual Hand Movements on Functional Tremor - a Pilot Study
Обзор
This study investigates the effect of virtual reality (VR) motor tasks on functional movement disorders.
Подробное описание
The investigators want to investigate how different display modes of virtual hands and the experimental manipulation of the visual representation of virtual hand movements affect (1) the performance of the hand movements (2) the tremor and (3) the subjective perception of the tremor.
There are three groups: Patients with functional tremor (FT), patients with essential tremor (ET) and healthy controls (HC). The study is carried out on one or two consecutive days. The first appointment is only made for patients with ET and FT and is used for the neurological examination and to assess the severity of the tremor. It takes place at the Outpatient Clinic for Movement Disorders at the University Clinic for Neurology in Graz and lasts a maximum of 30 minutes. The second appointment is at the Institute of Psychology at the University of Graz and requires the active participation of the respondent for 2.5 hours. Subjects are asked not to take any tremor-influencing medication on the day of the examination. HC will only attend the appointment at the Institute of Psychology.
First appointment:
* Clinical Global Impression - Severity Scale (CGI-S): 5-point Likert scale, clinicians assess the severity of the condition * Patient Global Impression of Severity (PGI-S): 5-point Likert scale, patients assess the severity of the condition * Fahn Tolosa Marin Tremor Rating Scale (FTM): assesses the tremor severity * Simplified Version of the Functional Movement Disorders Rating Scale (S-FMDRS): assesses the severity of the functional tremor
Second appointment:
1. Questionnaires:
* Simulator Sickness Questionnaire (SSQ): 4-point Likert scale, assesses nausea, oculomotor and visual disturbances, disorientation (2 timepoints: before and after VR tasks) * Edinburgh Handedness Inventory (EDI) * Questionnaire about sociodemographic data * Technology Usage Inventory (TUI): 7-point Likert scale, acceptance and use of technologies * Igroup Presence Questionnaire (IPQ): sense of presence in the VR 2. electroencephalogram (EEG) and surface-Electromyography (surface-EMG) of forearm muscles: run synchronously with the examinations 3. VR-tasks: all tasks are carried out in randomized order
1. 3x3 matrix: individual fields light up in random order, participants are instructed to touch the fields in the given sequence as quickly as possible. 30 repetitions with a realistic VR-hand model and 30 repetitions with an abstract VR-hand model. 2. 3x3 matrix: same task as (a) but after each repetition, participants must touch a field labeled "next" to continue the task. 30 repetitions. 3. apple in a box: a virtual apple is to be placed in a virtual box using the hand with the weaker tremor, while the other hand is left resting on the table. 30 repetitions. 4. apple in a box: same task as (c) but the resting hand is not visible. 30 repetitions.
Вмешательства
- Диагностический тест Virtual reality motor task
After a short practice task, participants perform motor tasks in a virtual reality environment. Reaction time is used to assess task performance.
Первичные конечные точки
- Task performance [Срок оценки: 4 measurement points: abstract hand model without time pressure, abstract hand model with time pressure, realistic hand model without time pressure, realistic hand model with time pressure. Approximately 2.5 hours]
Вторичные конечные точки (4)
- Tremor duration [Срок оценки: 5 measurement points: tasks a, b, c, d; Approximately 2.5 hours]
- EEG [Срок оценки: 10 measurement points: resting state before each motor task and during each motor task; Approximately 2.5 hours]
- Subjective tremor severity on a visual analogue scale (VAS) [Срок оценки: 6 measurement points: before and after each task; Approximately 2.5 hours]
- VR acceptance [Срок оценки: 2 measurement points: before and after the VR examination, Approximately 2.5 hours]
Критерии участия
Критерии включения
- diagnosis of functional tremor (FT) or essential tremor (ET) or healthy control persons
- In patients with FT and ET: presence of a constant or intermittent tremor during the neurological examination
Критерии исключения
- unclear tremor syndrome
- essential tremor plus (ET plus)
- conditions that interfere with EEG diagnostic (skin conditions, skin infections, wounds)
- reflex epilepsy
- cervical degeneration or chronic pain syndrome of the cervical spine
- severe somatic illness
- previous cerebral or head surgery
- implanted pacemaker or deep brain stimulation
- persons who are unable to consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Фундаментальное исследование
Центры проведения
Австрия · 1 центр
- Medical University of Graz, Department of Neurology — Graz
Идентификаторы
NCT: NCT06393439 · 36-115 ex 23/24