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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 85
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Italy
Istituti Clinici Scientifici Maugeri SpA
RECRUITING
Bari
IRCCS Azienda Ospedaliera Universitaria San Martino
RECRUITING
Genova
Centro Riabilitativo Villa Beretta
RECRUITING
Lecco
Fondazione Don Carlo Gnocchi Onlus, IRCCS
RECRUITING
Milan
University of Modena and Reggio Emilia
RECRUITING
Modena
Istituto Neurologico Nazionale IRCCS Casimiro Mondino
RECRUITING
Pavia
Contact Information
Primary
FRANCESCA BAGLIO, MD FRANCESCA BAGLIO, MD
fbaglio@dongnocchi.it
00390240308952
Backup
FEDERICA ROSSETTO, PhD
frossetto@dongnocchi.it
00390240308952
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 300
Treatments
Experimental: TRsA
Telerehabilitation (TR) single Approach - TRsA
Experimental: TRcA
Telerehabilitation (TR) combined Approach - TRcA
Placebo_comparator: ET
Educational treatment - ET
Sponsors
Collaborators: Fondazione Don Carlo Gnocchi Onlus, IRCCS Milano, Fondazione Don Carlo Gnocchi Onlus, Centro S Maria della Provvidenza, Roma, Fondazione Mondino, Istituti Clinici Scientifici Maugeri SpA, IRCCS Milano, Istituti Clinici Scientifici Maugeri SpA, IRCCS Telese, Istituti Clinici Scientifici Maugeri SpA, IRCCS Montescano, Centro Riabilitativo Villa Beretta, University of Modena and Reggio Emilia, IRCCS Azienda Ospedaliera Universitaria San Martino - Genova, Istituti Clinici Scientifici Maugeri SpA, IRCCS Bari, Istituti Clinici Scientifici Maugeri SpA, IRCCS Pavia
Leads: Fondazione Don Carlo Gnocchi Onlus

This content was sourced from clinicaltrials.gov