teleRehabilitation for pAtients With ParkInson's Disease at Any mOment

Parkinson Disease Clinical Trial

— RAPIDO  

Official title:

teleRehabilitation for pAtients With ParkInson's Disease at Any mOment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272448
• Other study ID #: CERM2022-27 21042022
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: February 2024
• Source: Università Politecnica delle Marche
• Contact: Maria Gabriella Ceravolo, Prof
• Phone: 0715964526
• Email: m.g.ceravolo[@]univpm.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the feasibility and safety of a telerehabilitation and telemonitoring approach in people with Parkinson's disease at any stage. The main questions it aims to answer are: will patients with Parkinson's 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 patient's 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 therapists.They 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.

Description:

In this cohort study, the feasibility and safety of a telerehabilitation and telemonitoring approach will be tested in people with Parkinson's 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 minutes/day, 3 times/week 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 days/week. 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 user's skills.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Parkinson's disease (according to Movement Disorder Society criteria)

• Ability to provide written informed consent.

Exclusion Criteria:

• moderate-severe cognitive impairment (MoCA=18)

• any other factor known to interfere with the ability to interact with the telerehabilitation platform (e.g. poor visual acuity, lack of family support);

• comorbidities with adverse impact on functioning or survival or affecting the performance of physical exercise (e.g. serious neoplastic diseases, cardiovascular diseases not controlled pharmacologically including arterial hypertension or hypotension, cardiac arrhythmias, heart failure, musculoskeletal diseases, dizziness or vertigo);

• severe depression or other neuropsychiatric disorders;

• expected need for adapting antiparkinsonian drug regimen over a 6 month period.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Telerehabilitation
The subjects will be instructed to login with own credentials to a telerehabilitation platform where a library of videoclips displaying as many different motor activities, grouped by difficulty 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 by the videoclips, for a total 45 minutes/day, at least 3 times/week (for no less than 27 sessions in total, equal to 1200 minutes of training). Subjects will be given a smartwatch to be worn 24 hours/ day, for at least 5 days/week. 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 user's skills

Locations

Country	Name	City	State
Italy	Neurorehabilitation Clinic	Ancona
Italy	Università di Verona	Verona

Sponsors (2)

Lead Sponsor	Collaborator
Università Politecnica delle Marche	Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with the telerehabilitation system	Number of training sessions / minimum number of recommended sessions (i.e. at least 27 sessions) over 3 months	At 3 months of baseline (end of treatment)
Primary	Perceived usability of system	SYSTEM USABILITY SCALE (range 0-100, with 100 being the maximum usability perception)	At 3 months of baseline (end of treatment)
Primary	Incidence of treatment-emergent adverse events	N. of adverse events occurring while using the telerehabilitation system	At 3 months of baseline (end of treatment)
Secondary	User satisfaction	Patient Global Rating of Change (range: from -3 to + 3, with negative scores conveying a perception of worsening)	At 3 months of baseline (end of treatment)
Secondary	Compliance with the monitoring system	Total smartwatch activation duration/minimum expected activation duration (i.e. 24 hours/day x 3 months)	At 3 months of baseline (end of treatment)
Secondary	Feasibility of telemonitoring approach	(n. of remote contacts with the physiotherapists/minimum number of planned contacts (i.e. at least 5 over 3 months);	At 3 months of baseline (end of treatment)
Secondary	Motor symptom and disability progression	Change in the Unified Parkinson's Disease Rating Scale score (range 0-260, 0= no symptoms, complete independence)	At baseline and 3 and 6 months after
Secondary	Non motor symptom progression	Change in the NonMotor Symptoms Scale score (range 0-360, 0= no symptoms)	At baseline and 3 and 6 months after
Secondary	Patients' Quality of life	Change in Parkinson's Disease Questionnaire PDQ-8 score (range 0-32, 0=best quality of life)	At baseline and 3 and 6 months after
Secondary	Caregiver's burden	Change in ZARIT BURDEN INTERVIEW 22.item score (range 0-88, 0= best condition)	At baseline and 3 and 6 months after