Effect of Visual Feedback From the SpiroGym Mobile Application
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorGeneral University Hospital, Prague
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Parkinsons disease
Stable dopaminergic medication (stable dose for at least 1 month)
Disqualifiers
Other neurological disorders
Significant cognitive impairment
Major psychiatric disorder
History of head or neck cancer or previous surgical interventions in the neck region.
Trial design
Design model
Crossover
Treatments tested in this trial
EMST with SpiroGym app
DeviceParticipants 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 app
DeviceParticipants 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: EMST with video feedback via the SpiroGym mobile applicationExperimental treatment 1 intervention
Group B: EMST without video feedback via the SpiroGym mobile applicationActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, week 2Secondary outcomes
1
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.
Time frame
Baseline, week 22
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.
Time frame
Baseline, week 23
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.
Time frame
week 2Sponsors and contacts
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Source ClinicalTrials.gov