Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481540
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-25
Brief Title:
SpiroGym App-Aided Cough Rehabilitation
Sponsor:
General University Hospital Prague
Organization:
General University Hospital Prague
Study Overview
Official Title:
Effect of the SpiroGym App on Voluntary Cough Strength in Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESApp PD
Brief Summary:
The pilot study by Srp et al 2021 proved that the SpiroGym app was feasible for supporting expiratory muscle strength training EMST in Parkinsons disease PD patients Two weeks of intensive 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 SpiroGyms visual feedback was considered It was assumed that visual feedback increased training effort compared to regular training without immediate control However comparative studies were required to verify the possible additional effects of visual feedback on voluntary PCF compared to EMST without feedback
Detailed Description:
Goal To explore the visual feedback effect of the SpiroGym app in EMST on voluntary peak cough
Hypothesis Voluntary peak cough flow will be higher at the 8-week assessment in the experimental group than in the active control group
Study Design A double-blind randomized controlled trial
Hypothesis Voluntary peak cough flow will be higher at the 8-week assessment in the experimental group than in the active control group
Study Design A double-blind randomized controlled trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None