Telehealth rehabilitation for neurodegenerative diseases
Official title: Effectiveness of TeleNEUROrehabilitation Systems for Timely and Personalized Interventions and Vigilant Care in Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
Run by Fondazione Don Carlo Gnocchi ETS · NCT06685744 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 25 Years to 85 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Fondazione Don Carlo Gnocchi ETS Academic / other |
| Locations | 6 sites (Bari and 5 other locations) |
| Status | Recruiting |
| Started | October 23, 2024 |
| Main results expected | May 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | March 3, 2025 |
| Trial ID | NCT06685744 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with severe comorbidities, major psychiatric complications, or significant cognitive deficits may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with telerehabilitation approaches, indicating potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: fbaglio@dongnocchi.it
- Phone: 00390240308952
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.