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Идёт набор NCT06942533

Effect of Visual Feedback From the SpiroGym Mobile Application

Без фазы С лечением Parkinson Disease Breathing Exercises Telemedicine

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: EMST with SpiroGym app, EMST without SpiroGym app.
Кому может быть актуально
Состояния в реестре: Parkinson Disease, Breathing Exercises, Telemedicine. Базовые параметры: 40 лет — 80 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
Чехия
Следующий шаг
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Официальное название

The Effect of Visual Feedback From the SpiroGym Mobile Application on Expiratory Muscle Strength Training Performance in Patients With Parkinson's Disease

Обзор

The previous pilot study showed that two weeks of intensive expiratory muscle strength training (EMST) with SpiroGym was sufficient to significantly improve voluntary peak cough flow (PCF). The improvement was quantitatively comparable to that reported in other intensive EMST studies of longer duration. To explain this rapid improvement, we considered the potential contribution of SpiroGym's visual feedback. We assumed that real-time visual feedback increased training effort compared with conventional EMST performed without immediate feedback. The aim of this study is to evaluate the effect of visual feedback provided by the SpiroGym mobile application on performance during expiratory muscle strength training in patients with Parkinson's disease.

Подробное описание

The study will be conducted using a prospective crossover design. Patients with Parkinson's disease will complete two EMST sessions, each at 75% of maximum expiratory pressure (MEP), separated by a two-week interval. One EMST session will include feedback via the SpiroGym mobile application, while the other will be performed without feedback. The order of these conditions will be randomly assigned.

Primary hypothesis

1. Visual feedback provided by the SpiroGym application during expiratory training will result in greater muscle activation, as measured by surface electromyography (sEMG), compared with training without visual feedback.

Secondary hypotheses 2. Visual feedback during expiratory training will lead to greater expiratory performance, reflected by higher noise intensity recorded by the SpiroGym application, than training without visual feedback. 3. Participants will report lower perceived difficulty and higher motivation to perform expiratory training exercises when visual feedback is provided than when it is absent.

Вмешательства

  • Устройство EMST with SpiroGym app
    Participants will perform expiratory muscle training using an Expiratory Muscle Trainer (EMST150; Aspire Products, LLC, United States). Participants will be instructed to perform five sets of five forceful expirations coupled with the SpiroGym app. Video feedback via the SpiroGym app: During correct performance of the expiratory manoeuvre with the handheld device, the exhalation valve opens and the resulting airflow increases the sound level detected by the microphone. Simultaneously, the appli
  • Устройство EMST without SpiroGym app
    Participants will perform expiratory muscle training using an Expiratory Muscle Trainer (EMST150; Aspire Products, LLC, United States). Participants will be instructed to perform five sets of five forceful expirations without the SpiroGym app.

Первичные конечные точки

  • Surphace elektromyography (sEMG) measurement of abdominal muscle (m. obliquus internus abdominis). [Срок оценки: Baseline, week 2]
Вторичные конечные точки (3)
  • SpiroGym Sound Intenzity (SSI) measurement [Срок оценки: Baseline, week 2]
  • Surphace elektromyography (sEMG) measurement of suprahyoid muscle complex and abdominal muscles (m. rectus abdominis and m. obliquus externus abdominis). [Срок оценки: Baseline, week 2]
  • Participant's Feedback questionnaire [Срок оценки: week 2]

Критерии участия

Критерии включения

  • Diagnosis of Parkinsons disease
  • Stable dopaminergic medication (stable dose for at least 1 month)

Критерии исключения

  • Other neurological disorders
  • Significant cognitive impairment
  • Major psychiatric disorder
  • History of head or neck cancer or previous surgical interventions in the neck region.
  • Illness during the study period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Чехия · 2 центра
  • General University Hospital — Prague
  • Department of Neurology and Centre of Clinical Neuroscience First Faculty of Medicine, Cha — Prague

Публикации

  • Srp M, Bartosova T, Klempir J, Lagnerova R, Gal O, Listvanova T, Jech R, Ruzicka E, Hoskovcova M. Expiratory Muscle Strength Training in Multiple System Atrophy: A Pilot Study. Mov Disord Clin Pract. 2023 May 19;10(7):1060-1065. doi: 10.1002/mdc3.13765. eCollection 2023 Jul. PMID 37476315

Идентификаторы

NCT: NCT06942533 · EXPARK

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗