teleRehabilitation for pAtients With ParkInson's Disease at Any mOment

NCT ID: NCT06272448

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-10-01

Brief 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.

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Telerehabilitation for 3 months

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: collaborator

Università Politecnica delle Marche

OTHER

Sponsor Role: lead

Responsible Party

Marianna Capecci, PhD

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Gabriella Ceravolo, Prof

Role: PRINCIPAL_INVESTIGATOR

Politecnica delle Marche University

Locations

Neurorehabilitation Clinic

Ancona, , Italy

Università di Verona

Verona, , Italy

Countries

Italy

Other Identifiers

CERM2022-27 21042022

Identifier Type: -

Identifier Source: org_study_id