Effect of Visual Feedback From the SpiroGym Mobile Application (EXPARK)

November 24, 2025 updated by: Martin Srp, Ph.D., General University Hospital, Prague

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Prague, Czechia, 120 00
        • Recruiting
        • General University Hospital
        • Contact:
        • Contact:
      • Prague, Czechia, 16000
        • Recruiting
        • Department of Neurology and Centre of Clinical Neuroscience First Faculty of Medicine, Charles University and General University Hospital in Prague
        • Contact:
          • Martin Srp, Ph.D.
          • Phone Number: +420224965513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMST with video feedback via the SpiroGym mobile application
Patients will complete one EMST session with the 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 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.

Active Comparator: EMST without video feedback via the SpiroGym mobile application
Patients will complete one EMST session without the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Baseline, week 2
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.
week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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