Effect of Visual Feedback From the SpiroGym Mobile Application

NCT06942533 | Recruiting

• 1 other identifier: EXPARK
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Parkinson Disease; Breathing Exercises; Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, week 2

Secondary Outcomes (3)

• 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

Study Arms (2)

EMST with video feedback via the SpiroGym mobile application

EXPERIMENTAL

Patients will complete one EMST session with the SpiroGym app.

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.

Device: EMST without SpiroGym app

Interventions

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 with video feedback via the SpiroGym mobile application

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.

EMST without video feedback via the SpiroGym mobile application

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (2)

General University Hospital

Prague, 120 00, Czechia

RECRUITING

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

Prague, 16000, Czechia

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Martin Srp, Ph.D.

CONTACT

+420224965513; martin.srp@vfn.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 24, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

CZ (2)