Telehealth rehabilitation for neurodegenerative diseases

Effectiveness of TeleNEUROrehabilitation Systems for Timely and Personalized Interventions and Vigilant Care in Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial

This study is testing if online rehabilitation programs can help people with Parkinson's Disease and Multiple Sclerosis feel better compared to traditional education methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 25 Years to 85 Years
• Sex: All
• Sponsor: Fondazione Don Carlo Gnocchi Onlus (other)
• Locations: 6 sites (Bari and 5 other locations)
• Trial ID: NCT06685744 on ClinicalTrials.gov

What this trial studies

The FIT4TeleNEURO pragmatic trial aims to evaluate the effectiveness of telerehabilitation protocols compared to conventional educational treatment for patients with Parkinson's Disease and Multiple Sclerosis. Participants will undergo a 5-week rehabilitation program with assessments at baseline, post-treatment, and follow-up to measure motor, cognitive, and quality-of-life outcomes. The study will compare two telerehabilitation approaches: a single task-oriented approach and a combined task-oriented and impairment-oriented approach. This research seeks to provide insights into the real-world application of digital rehabilitation methods.

Who should consider this trial

Good fit: Ideal candidates include adults aged 25 to 85 with diagnosed Parkinson's Disease or Multiple Sclerosis who have stable medication and no ongoing rehabilitation program.

Not a fit: Patients with severe comorbidities, major psychiatric complications, or significant cognitive deficits may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could enhance rehabilitation outcomes for patients with neurodegenerative conditions through innovative telerehabilitation methods.

How similar studies have performed: Other studies have shown promising results with telerehabilitation approaches, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* diagnosis of probable PD according to MDS criteria (Postuma et al., 2015) in staging between 1 and 3 on the Hoehn \& Yahr scale (Goetz et al., 2004) or diagnosis of MS according to the criteria of MC Donald 2010 (Polman et al., 2011) with disability level at the Expanded Disability Status Scale EDSS (Kurtzke, 1983) ≤ 4.5;
* age between 25 and 85 years;
* preserved cognitive level at the Montreal Cognitive Assessment test (MoCA test \>15.5) (Santangelo et al., 2015);
* no rehabilitation program in place at the time of enrolment;
* stable drug treatment (last three month) with L-Dopa or dopamine agonists (PD group) or Disease Modifying Therapies (DMTs) (MS group).

Exclusion Criteria:

* presence of comorbidities that might prevent patients from undertaking a safe home program or determining clinical instability (i.e., severe orthopedic or severe cognitive deficits);
* presence of major psychiatric complications or personality disorders;
* presence of severe impairment of visual and/or acoustic perception;
* falls resulting in injuries or more than 2 falls in the 6 months prior to recruitment (PD and MS groups).
* pregnancy
* relapse ongoing/at least 3 months since the last relapse (MS group);
* presence of "frequent" freezing as recorded at the administration of Section II (daily life activity) of the UPDRS (score ≥ 3) (PD group);
* EDSS-FS (cerebellar function) ≥ 3 (MS group).

Where this trial is running

Bari and 5 other locations

• Istituti Clinici Scientifici Maugeri SpA — Bari, Italy (RECRUITING)
• IRCCS Azienda Ospedaliera Universitaria San Martino — Genova, Italy (RECRUITING)
• Centro Riabilitativo Villa Beretta — Lecco, Italy (RECRUITING)
• Fondazione Don Carlo Gnocchi Onlus, IRCCS — Milan, Italy (RECRUITING)
• University of Modena and Reggio Emilia — Modena, Italy (RECRUITING)
• Istituto Neurologico Nazionale IRCCS Casimiro Mondino — Pavia, Italy (RECRUITING)

Study contacts

• Study coordinator: FRANCESCA BAGLIO, MD FRANCESCA BAGLIO, MD

Conditions: Parkinson Disease, Multiple Sclerosis, Neurologic Diseases, General, Telerehabilitation, Digital Medicine, Chronic Neurological diseases, Rehabilitation, Telemedicine