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

General University Hospital, Prague

Status: Not yet enrolling

Conditions: Parkinson Disease, Breathing Exercises, Visual Feedback

Treatments: Device: EMST without SpiroGym app; Device: EMST with SpiroGym app

Study type: Interventional

Funder types: Other

Identifiers

NCT06942533

EXPARK

Details and patient eligibility

About

The previous pilot study showed that two weeks of intensive expiratory muscle strength training (EMST) coupled with SpiroGym were sufficient to significantly improve the participants' voluntary peak cough flow (PCF). The improvement was quantitatively comparable to the results of other intensive EMST studies with longer durations. When interpreting such rapid improvement, the impact of SpiroGym's visual feedback was considered. It was assumed that visual feedback increased training effort compared to regular training without immediate control.

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.

Full description

The study will be conducted as a prospective crossover experimental design. Patients with Parkinson's disease will complete two EMST sessions (at 75% of maximum expiratory pressure), separated by a two-week period. One EMST session will include feedback via the SpiroGym mobile application, while the other will be conducted without such 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 higher muscle activation, as measured by surface electromyography (sEMG), compared to training without visual feedback.

Secondary hypothesis

1. Participants using visual feedback during expiratory training will demonstrate greater expiratory performance, reflected by higher noise intensity recorded by the SpiroGym application, than participants training without visual feedback.
2. Participants will report lower perceived difficulty and higher motivation to perform expiratory training exercises when visual feedback is provided, compared to when it is absent.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

EMST with video feedback via the SpiroGym mobile application

Experimental group

Description:

The experimental arm will undergo one EMST session coupled with the SpiroGym app.

Treatment:

Device: EMST with SpiroGym app

EMST without video feedback

Active Comparator group

Description:

The control arm will undergo one EMST session without the SpiroGym app.

Treatment:

Device: EMST without SpiroGym app