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临床试验/NCT06942533
NCT06942533招募中不适用

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

General University Hospital, Prague2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Surphace elektromyography (sEMG) measurement of abdominal muscle (m. obliquus internus abdominis).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

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

排除标准

  • •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

研究组 & 干预措施

EMST with video feedback via the SpiroGym mobile application

Experimental

Patients will complete one EMST session with the SpiroGym app.

干预措施: EMST with SpiroGym app (Device)

EMST without video feedback via the SpiroGym mobile application

Active Comparator

Patients will complete one EMST session without the SpiroGym app.

干预措施: EMST without SpiroGym app (Device)

结局指标

主要结局

Surphace elektromyography (sEMG) measurement of abdominal muscle (m. obliquus internus abdominis).

时间窗: Baseline, week 2

Wireless sEMG electrodes will be placed on the clean skin of the abdominal muscle (m. obliquus internus abdominis). A reference voluntary contraction (RVC) will be used to normalize the sEMG data. sEMG of the abdominal muscle (m. obliquus internus abdominis) during two conditions (EMST with SpiroGym and EMST without SpiroGym) will be compared.

次要结局

  • SpiroGym Sound Intenzity (SSI) measurement(Baseline, week 2)
  • SpiroGym Sound Intenzity (SSI) measurement(Baseline, week 2)
  • Surphace elektromyography (sEMG) measurement of suprahyoid muscle complex and abdominal muscles (m. rectus abdominis and m. obliquus externus abdominis).(Baseline, week 2)
  • Participant's Feedback questionnaire(week 2)

研究者

发起方
General University Hospital, Prague
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Srp, Ph.D.

Chief physiotherapist

General University Hospital, Prague

研究点 (2)

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