Parkinson DiseaseRAPIDONCT06272448
teleRehabilitation for pAtients With ParkInson's Disease at Any mOment
A study testing Telerehabilitation in people with Parkinson Disease, run by Università Politecnica delle Marche at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Nov 2022to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease (according to Movement Disorder Society criteria)
- Ability to provide written informed consent.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Italy2 sites
Neurorehabilitation Clinic
Ancona, 60126
Università di Verona
Verona, 37100
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Telerehabilitation
- Keywords
- Telerehabilitation, Telemonitoring, Empowerment, Functioning
- Medical subject headings
- Parkinson Disease, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Telerehabilitation for 3 months Receives: Other: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with the telerehabilitation system
Number of training sessions / minimum number of recommended sessions (i.e. at least 27 sessions) over 3 months
Measured: 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)
Measured: At 3 months of baseline (end of treatment)
Incidence of treatment-emergent adverse events
- of adverse events occurring while using the telerehabilitation system
Measured: At 3 months of baseline (end of treatment)
Secondary outcomes (7)
User satisfaction
Patient Global Rating of Change (range: from -3 to + 3, with negative scores conveying a perception of worsening)
Measured: At 3 months of baseline (end of treatment)
Compliance with the monitoring system
Total smartwatch activation duration/minimum expected activation duration (i.e. 24 hours/day x 3 months)
Measured: 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);
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At baseline and 3 and 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start15 Nov 2022
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before-after study with one follow-up at 3 months of treatment end
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona
- Responsible party
- Principal investigator, Marianna Capecci, PhD, Università Politecnica delle Marche
- Investigators
- Maria Gabriella Ceravolo, Prof, Principal investigator, Politecnica delle Marche University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272448
- Sponsor's protocol ID
- CERM2022-27 21042022
- Acronym
- RAPIDO
- Status last verified
- Nov 2024
- First submitted
- 16 Jan 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- teleRehabilitation for pAtients With ParkInson's Disease at Any mOment
- ClinicalTrials.gov ID
- NCT06272448
- Acronym / sponsor ID
- RAPIDO / CERM2022-27 21042022
- Conditions
- Parkinson Disease
- Keywords
- Telerehabilitation, Telemonitoring, Empowerment, Functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Collaborators
- Universita di Verona
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before-after study with one follow-up at 3 months of treatment end
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: TelerehabilitationTelerehabilitation for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Parkinson's disease (according to Movement Disorder Society criteria)
- Ability to provide written informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationThe 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 | Other | Intervention |
Primary outcome
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
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)
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
7 secondary outcomes
User satisfaction
Time frame: At 3 months of baseline (end of treatment)
Compliance with the monitoring system
Time frame: At 3 months of baseline (end of treatment)
Feasibility of telemonitoring approach
Time frame: At 3 months of baseline (end of treatment)
Motor symptom and disability progression
Time frame: At baseline and 3 and 6 months after
Non motor symptom progression
Time frame: At baseline and 3 and 6 months after
Patients' Quality of life
Time frame: At baseline and 3 and 6 months after
Caregiver's burden
Time frame: At baseline and 3 and 6 months after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Gabriella Ceravolo, Prof principal investigator
Politecnica delle Marche University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Parkinson Disease, run by Università Politecnica delle Marche at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with the telerehabilitation system (time frame: At 3 months of baseline (end of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.