Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272448
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-01-16
Brief Title:
teleRehabilitation for pAtients With ParkInsons Disease at Any mOment
Sponsor:
Università Politecnica delle Marche
Organization:
Università Politecnica delle Marche
Study Overview
Official Title:
teleRehabilitation for pAtients With ParkInsons Disease at Any mOment
Status:
RECRUITING
Status Verified Date:
2024-02
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:
RAPIDO
Brief Summary:
The goal of this clinical trial is to test the feasibility and safety of a telerehabilitation and telemonitoring approach in people with Parkinsons disease at any stage The main questions it aims to answer are will patients with Parkinsons disease comply with the recommended level of training at home using an ad hoc developed telerehabilitation platform Will this training be safe and impact the patients well-being perception Participants will be given a tablet and instructed to access an online platform to observe different motor tasks presented in as many video clips by experienced therapistsThey will be requested to perform the motor tasks per a predetermined protocol over 3 months Their compliance with the recommended training will be checked by physiotherapists every 15 days during phone calls whereas their daily level of motor activity will be recorded by a smartwatch
Detailed Description:
In this cohort study the feasibility and safety of a telerehabilitation and telemonitoring approach will be tested in people with Parkinsons disease at any stage Enrolled subjects will be given a tablet through which they will log in with their own credentials to a telerehabilitation platform where a library of videoclips displaying as many different motor activities grouped by difficulty very easy - easy- advanced and function domain trunk alignment balance hand dexterity speech articulation ventilation will be available Patients will perform the exercises according to a pre-determined training protocol observing and imitating the tasks presented in the videoclips by experienced physiotherapists or speech therapists A training duration of 45 minutesday 3 timesweek for no less than 27 sessions equal to 1200 minutes of total training will be recommended Moreover subjects will be given a smartwatch to be worn 24 hours day for at least 5 daysweek Every 15 - 3 days one physiotherapist will call the patients to check the correct use of the devices the level of adherence to the exercise program and the need for shaping the training difficulty to the users skills
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