NCT06685744Recruiting
TeleNEURO-Rehabilitation Systems for Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
Effectiveness of TeleNEUROrehabilitation Systems for Timely and Personalized Interventions and Vigilant Care in Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
Source: ClinicalTrials.gov · Last updated 3 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of the FIT4TeleNEURO pragmatic trial is to verify, in real-life care contexts, the superiority in terms of the effectiveness of early rehabilitation intervention with Telerehabilitation (TR) protocols (TR single Approach, task-oriented - TRsA; TR combined approach, task-oriented and impairment-oriented - TRcA) compared to conventional management (Educational treatment, ET). The main questions it aims to answer are: * Are Telerehabilitation protocols more effective than educational treatment? * Is the TRcA treatment more effective than the TRsA? The study investigates the effects of rehabilitation treatment by comparing the two target cases (Multiple Sclerosis - MS and Parkinson's Diseases - PD). Participants will be subjective to: * 3 time-point of assessment (baseline, post-treatment and follow up) with motor, cognitive and quality-of-life measures * A 5-weeks rehabilitation treatment (4 times/week)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 29 Oct 2024
- Start date
- 23 Oct 2024
- Primary completion date
- 30 May 2026
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Parkinson disease, Multiple sclerosis
- NCT number
- NCT06685744
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 23 Oct 2024 to the primary completion date, 30 May 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- falls resulting in injuries or more than 2 falls in the 6 months prior to recruitment (PD and MS groups).
Other illness
- presence of major psychiatric complications or personality disorders;
- presence of severe impairment of visual and/or acoustic perception;
Other
- 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);
- 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).
Who the study is looking for
- 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).
Age in the registry: 25 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituti Clinici Scientifici Maugeri SpA Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| IRCCS Azienda Ospedaliera Universitaria San Martino Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| Centro Riabilitativo Villa Beretta Coordinator of this site? Confirm its status | Lecco | Italy | Recruiting |
| Fondazione Don Carlo Gnocchi Onlus, IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| University of Modena and Reggio Emilia Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| Istituto Neurologico Nazionale IRCCS Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.