teleRehabilitation for pAtients With ParkInson's Disease at Any mOment

NCT06272448 | Completed

• 1 other identifier: CERM2022-27 21042022
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

Telerehabilitation; Telemonitoring; Empowerment; Functioning

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (7)

• User satisfaction

  At 3 months of baseline (end of treatment)

• Compliance with the monitoring system

  At 3 months of baseline (end of treatment)

• Feasibility of telemonitoring approach

  At 3 months of baseline (end of treatment)

• Motor symptom and disability progression

  At baseline and 3 and 6 months after

• Non motor symptom progression

  At baseline and 3 and 6 months after

Study Arms (1)

Intervention

EXPERIMENTAL

Telerehabilitation for 3 months

Other: Telerehabilitation

Interventions

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's disease (according to Movement Disorder Society criteria)
• Ability to provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università Politecnica delle Marche: lead
• Universita di Verona: collaborator

Study Sites (2)

Neurorehabilitation Clinic

Ancona, 60126, Italy

Location

Università di Verona

Verona, 37100, Italy

Location

MeSH Terms

Conditions

Parkinson Disease; Empowerment

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Maria Gabriella Ceravolo, Prof

  Politecnica delle Marche University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Before-after study with one follow-up at 3 months of treatment end

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 22, 2024
• Study Start: November 15, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

IT (2)