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

U

Università Politecnica delle Marche

Status

Completed

Conditions

Parkinson Disease

Treatments

Other: Telerehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06272448
CERM2022-27 21042022

Details and patient eligibility

About

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.

Full 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.

Enrollment

103 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

103 participants in 1 patient group

Intervention
Experimental group
Description:
Telerehabilitation for 3 months
Treatment:
Other: Telerehabilitation

Trial contacts and locations

2

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Central trial contact

Marianna Capecci, Prof; Maria Gabriella Ceravolo, Prof

Data sourced from clinicaltrials.gov

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