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Recruiting NCT06942533

Effect of Visual Feedback From the SpiroGym Mobile Application

No phase Interventional Parkinson Disease Breathing Exercises Telemedicine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EMST with SpiroGym app, EMST without SpiroGym app.
Who it may be relevant to
Registry conditions: Parkinson Disease, Breathing Exercises, Telemedicine. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Device 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
  • Device 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.

Primary outcome measures

  • Surphace elektromyography (sEMG) measurement of abdominal muscle (m. obliquus internus abdominis). [Time frame: Baseline, week 2]
Secondary outcome measures (3)
  • SpiroGym Sound Intenzity (SSI) measurement [Time frame: Baseline, week 2]
  • Surphace elektromyography (sEMG) measurement of suprahyoid muscle complex and abdominal muscles (m. rectus abdominis and m. obliquus externus abdominis). [Time frame: Baseline, week 2]
  • Participant's Feedback questionnaire [Time frame: week 2]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

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

Publications

  • 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

Identifiers

NCT: NCT06942533 · EXPARK

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗