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| Name | Class |
|---|---|
| Universita di Verona | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Telerehabilitation for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation | 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 |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Gabriella Ceravolo, Prof | Politecnica delle Marche University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurorehabilitation Clinic | Ancona | 60126 | Italy | |||
| Università di Verona |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D000079102 | Empowerment |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Before-after study with one follow-up at 3 months of treatment end
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|
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 |
| Verona |
| 37100 |
| Italy |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |