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Completed

NCT Number: NCT06272448

teleRehabilitation for pAtients With ParkInson's Disease at Any mOment

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Empowerment Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Social Behavior Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurorehabilitation Clinic, Ancona, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Compliance with the telerehabilitation system

    Time frame: 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

  2. Perceived usability of system

    Time frame: At 3 months of baseline (end of treatment)

    SYSTEM USABILITY SCALE (range 0-100, with 100 being the maximum usability perception)

  3. Incidence of treatment-emergent adverse events

    Time frame: At 3 months of baseline (end of treatment)

    N. of adverse events occurring while using the telerehabilitation system

Secondary outcomes

  1. User satisfaction

    Time frame: 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)

  2. Compliance with the monitoring system

    Time frame: At 3 months of baseline (end of treatment)

    Total smartwatch activation duration/minimum expected activation duration (i.e. 24 hours/day x 3 months)

  3. Feasibility of telemonitoring approach

    Time frame: 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);

  4. Motor symptom and disability progression

    Time frame: 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)

  5. Non motor symptom progression

    Time frame: At baseline and 3 and 6 months after

    Change in the NonMotor Symptoms Scale score (range 0-360, 0= no symptoms)

  6. Patients' Quality of life

    Time frame: 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)

  7. Caregiver's burden

    Time frame: At baseline and 3 and 6 months after

    Change in ZARIT BURDEN INTERVIEW 22.item score (range 0-88, 0= best condition)

Sponsors and collaborators

Lead sponsor

Università Politecnica delle Marche

Other

Collaborators

  • Universita di Verona

Registry information

Acronym: RAPIDO

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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