- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06942533
Effect of Visual Feedback From the SpiroGym Mobile Application (EXPARK)
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
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Martin Srp, Ph.D.
- Phone Number: +420224965513
- Email: martin.srp@vfn.cz
Study Locations
-
-
-
Prague, Czechia, 120 00
- Recruiting
- General University Hospital
-
Contact:
- Martin Srp, PhD
- Phone Number: +420224965513
- Email: martin.srp@vfn.cz
-
Contact:
- Martin Srp, PhD
- Phone Number: 224965513
- Email: martin.srp@vfn.cz
-
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
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXPARK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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