Clinical trial NCT06272448: teleRehabilitation for pAtients With ParkInson's Disease at Any mOment
Official title: teleRehabilitation for pAtients With ParkInson's Disease at Any mOment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Telerehabilitation
Telemonitoring
Empowerment
Functioning
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
Collaborators: name: Universita di Verona
First posted: 2024-02-22
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before-after study with one follow-up at 3 months of treatment end
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Compliance with the telerehabilitation system
timeFrame: At 3 months of baseline (end of treatment)
measure: Perceived usability of system
timeFrame: At 3 months of baseline (end of treatment)
measure: Incidence of treatment-emergent adverse events
timeFrame: At 3 months of baseline (end of treatment)
Secondary outcomes:
measure: User satisfaction
timeFrame: At 3 months of baseline (end of treatment)
measure: Compliance with the monitoring system
timeFrame: At 3 months of baseline (end of treatment)
measure: Feasibility of telemonitoring approach
timeFrame: At 3 months of baseline (end of treatment)
measure: Motor symptom and disability progression
timeFrame: At baseline and 3 and 6 months after
measure: Non motor symptom progression
timeFrame: At baseline and 3 and 6 months after
measure: Patients' Quality of life
timeFrame: At baseline and 3 and 6 months after
measure: Caregiver's burden
timeFrame: At baseline and 3 and 6 months after
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Neurorehabilitation Clinic
city: Verona
country: Italy
facility: Università di Verona
Study officials:
affiliation: Politecnica delle Marche University
name: Maria Gabriella Ceravolo, Prof
role: PRINCIPAL_INVESTIGATOR
References: