teleRehabilitation for pAtients With ParkInson's Disease at Any mOment (RAPIDO)

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Telerehabilitation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy, 60126
    • Neurorehabilitation Clinic
  • Verona, Italy, 37100
    • Universita di Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Telerehabilitation for 3 months

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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
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
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
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

Collaborators and Investigators

• Sponsor: Università Politecnica delle Marche
• Collaborators: Universita di Verona
• Investigators: Principal Investigator: Maria Gabriella Ceravolo, Prof, Politecnica delle Marche University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Telemonitoring; Telerehabilitation; Empowerment; Functioning
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: CERM2022-27 21042022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No