Parkinson DiseaseEXPARKNCT06942533
Effect of Visual Feedback From the SpiroGym Mobile Application
A study testing EMST with SpiroGym app and EMST without SpiroGym app in people with Parkinson Disease and Breathing Exercises, run by General University Hospital, Prague at 2 sites in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease, Breathing Exercises, Telemedicine
- What is being tested?
- EMST with SpiroGym app and EMST without SpiroGym app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 May 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinsons disease
- Stable dopaminergic medication (stable dose for at least 1 month)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites, 2 recruiting
- Recruiting
General University Hospital
Prague, 120 00
Martin Srp, PhD, +420224965513, martin.srp@vfn.cz
Martin Srp, PhD, 224965513, martin.srp@vfn.cz
- Recruiting
Department of Neurology and Centre of Clinical Neuroscience First Faculty of Medicine, Charles University and General University Hospital in Prague
Prague, 16000
Martin Srp, Ph.D., +420224965513
About this study
Official title: 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.
Read the 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
- 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.
- Conditions
- Parkinson Disease, Breathing Exercises, Telemedicine
- Being tested
- EMST with SpiroGym app, EMST without SpiroGym app
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMST with SpiroGym appDevice
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 appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EMST with video feedback via the SpiroGym mobile application | Experimental | Patients will complete one EMST session with the SpiroGym app. Receives: Device: EMST with SpiroGym app |
| EMST without video feedback via the SpiroGym mobile application | Active comparator | Patients will complete one EMST session without the SpiroGym app. Receives: Device: EMST without SpiroGym app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surphace elektromyography (sEMG) measurement of abdominal muscle (m. obliquus internus abdominis).
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.
Measured: Baseline, week 2
Secondary outcomes (3)
SpiroGym Sound Intenzity (SSI) measurement
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.
Measured: Baseline, week 2
Surphace elektromyography (sEMG) measurement of suprahyoid muscle complex and abdominal muscles (m. rectus abdominis and m. obliquus externus abdominis).
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.
Measured: Baseline, week 2
Participant's Feedback questionnaire
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.
Measured: week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each PD patient will complete two EMST sessions separated by a two-week period. One session will include feedback via the SpiroGym mobile application, while the other will be performed without such feedback. The order of these conditions will be randomly assigned. Patients cannot be fully blinded in this trial, as they may subjectively perceive differences between conditions. However, they will be partially blinded by withholding information about the study hypothesis. Patients will be informed only that the study compares different strategies for expiratory muscle training. If a patient asks which intervention is more effective, the examiner will respond that both methods are expected to be equally effective.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Srp, Ph.D., General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942533
- Sponsor's protocol ID
- EXPARK
- Acronym
- EXPARK
- Status last verified
- Nov 2025
- First submitted
- 9 Apr 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 37476315Srp M, Dvorakova K, Muzik J, Janderova P, Sevcik M, Matys V, Vitek J, Kliment R, Hoskovcova M, Ruzicka E. Visual feedback increases expiratory muscle training effort in Parkinson's disease: a randomised crossover trial. J Neuroeng Rehabil. 2026 Jul 22;23(1):298. doi: 10.1186/s12984-026-02104-5.
PubMed 42881452
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visual Feedback From the SpiroGym Mobile Application on Expiratory Muscle Strength Training Performance in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06942533
- Acronym / sponsor ID
- EXPARK / EXPARK
- Conditions
- Parkinson Disease, Breathing Exercises, Telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each PD patient will complete two EMST sessions separated by a two-week period. One session will include feedback via the SpiroGym mobile application, while the other will be performed without such feedback. The order of these conditions will be randomly assigned. Patients cannot be fully blinded in this trial, as they may subjectively perceive differences between conditions. However, they will be partially blinded by withholding information about the study hypothesis. Patients will be informed only that the study compares different strategies for expiratory muscle training. If a patient asks which intervention is more effective, the examiner will respond that both methods are expected to be equally effective.
| Arm | Type | Receives |
|---|---|---|
| EMST with video feedback via the SpiroGym mobile application | Experimental | Device: EMST with SpiroGym appPatients will complete one EMST session with the SpiroGym app. |
| EMST without video feedback via the SpiroGym mobile application | Active comparator | Device: EMST without SpiroGym appPatients will complete one EMST session without the SpiroGym app. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Parkinsons disease
- Stable dopaminergic medication (stable dose for at least 1 month)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMST with SpiroGym appParticipants 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. | Device | EMST with video feedback via the SpiroGym mobile application |
| EMST without SpiroGym appParticipants 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. | Device | EMST without video feedback via the SpiroGym mobile application |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Background: PubMed 37476315Srp 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.
- Derived from this study: PubMed 42881452Srp M, Dvorakova K, Muzik J, Janderova P, Sevcik M, Matys V, Vitek J, Kliment R, Hoskovcova M, Ruzicka E. Visual feedback increases expiratory muscle training effort in Parkinson's disease: a randomised crossover trial. J Neuroeng Rehabil. 2026 Jul 22;23(1):298. doi: 10.1186/s12984-026-02104-5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMST with SpiroGym app and EMST without SpiroGym app in people with Parkinson Disease and Breathing Exercises, run by General University Hospital, Prague at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Srp, Ph.D. (+420224965513, martin.srp@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surphace elektromyography (sEMG) measurement of abdominal muscle (m. obliquus internus abdominis). (time frame: Baseline, week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06942533, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.