Parkinson Disease
Conditions
Keywords
Telerehabilitation, Telemonitoring, Empowerment, Functioning
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.
Interventions
OTHERTelerehabilitation
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
Sponsors
Universita di Verona
Università Politecnica delle Marche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Before-after study with one follow-up at 3 months of treatment end
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance with the telerehabilitation system | At 3 months of baseline (end of treatment) | Number of training sessions / minimum number of recommended sessions (i.e. at least 27 sessions) over 3 months |
| Perceived usability of system | At 3 months of baseline (end of treatment) | SYSTEM USABILITY SCALE (range 0-100, with 100 being the maximum usability perception) |
| Incidence of treatment-emergent adverse events | At 3 months of baseline (end of treatment) | N. of adverse events occurring while using the telerehabilitation system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor symptom and disability progression | At baseline and 3 and 6 months after | Change in the Unified Parkinson's Disease Rating Scale score (range 0-260, 0= no symptoms, complete independence) |
| Non motor symptom progression | At baseline and 3 and 6 months after | Change in the NonMotor Symptoms Scale score (range 0-360, 0= no symptoms) |
| User satisfaction | At 3 months of baseline (end of treatment) | Patient Global Rating of Change (range: from -3 to + 3, with negative scores conveying a perception of worsening) |
| Caregiver's burden | At baseline and 3 and 6 months after | Change in ZARIT BURDEN INTERVIEW 22.item score (range 0-88, 0= best condition) |
| Patients' Quality of life | At baseline and 3 and 6 months after | Change in Parkinson's Disease Questionnaire PDQ-8 score (range 0-32, 0=best quality of life) |
| Compliance with the monitoring system | At 3 months of baseline (end of treatment) | Total smartwatch activation duration/minimum expected activation duration (i.e. 24 hours/day x 3 months) |
| Feasibility of telemonitoring approach | At 3 months of baseline (end of treatment) | (n. of remote contacts with the physiotherapists/minimum number of planned contacts (i.e. at least 5 over 3 months); |
Countries
Italy
Outcome results
None listed