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NCT Number: NCT06942533

Effect of Visual Feedback From the SpiroGym Mobile Application

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Breathing Exercises Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies Telemedicine

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology and Centre of Clinical Neuroscience First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czechia

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About this study

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

  • 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

  • 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.
  • Participants will report lower perceived difficulty and higher motivation to perform expiratory training exercises when visual feedback is provided than when it is absent.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMST with SpiroGym app

Device

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 application provides real-time visual feedback on the mobile phone screen as a curve depicting the current sound level. The patient's task is to keep the curve within the training zone, defined by two lines corresponding to the lower and upper thresholds.

EMST without SpiroGym app

Device

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 outcomes

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

    Time frame: 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.

Secondary outcomes

  1. SpiroGym Sound Intenzity (SSI) measurement

    Time frame: Baseline, week 2

    The output from the SpiroGym application (SpiroGym Sound Intensity - SSI), which records the intensity of the sound generated by the expiratory device (note: the louder the sound, the greater the expiratory force) during two conditions (EMST with SpiroGym and EMST without SpiroGym) will be compared.

  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

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

  3. Participant's Feedback questionnaire

    Time frame: week 2

    After all the maneuvers were completed over the two sessions, participants will complete a questionnaire focused on the subjective perception of exercise difficulty and motivation to perform it with or without visual feedback. The questionnaire will be rated using a Likert scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Srp, Ph.D.

CONTACT

[email protected]

+420224965513

Sponsors and collaborators

Lead sponsor

General University Hospital, Prague

Other

Registry information

Official study title

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

Acronym: EXPARK

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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