Actively Recruiting
TeleNEURO-Rehabilitation Systems for Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-03-03
300
Participants Needed
6
Research Sites
87 weeks
Total Duration
On this page
Sponsors
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
F
Fondazione Don Carlo Gnocchi Onlus, IRCCS Milano
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
TeleNEURO-Rehabilitation Systems for Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of probable Parkinson Disease between stages 1 and 3 on the Hoehn & Yahr scale or diagnosis of Multiple Sclerosis with disability level EDSS 64.5
- Age between 25 and 85 years
- Cognitive level above 15.5 on the Montreal Cognitive Assessment (MoCA) test
- Not currently participating in any rehabilitation program
- Stable drug treatment for at least three months: L-Dopa or dopamine agonists for Parkinson Disease, or Disease Modifying Therapies for Multiple Sclerosis
You will not qualify if you...
- Presence of comorbidities preventing safe home rehabilitation or causing clinical instability
- Major psychiatric complications or personality disorders
- Severe visual or hearing impairments
- History of falls causing injury or more than two falls in the six months before enrollment
- Pregnancy
- For Multiple Sclerosis: ongoing relapse or relapse within the last three months
- For Parkinson Disease: frequent freezing with a score of 3 or higher on UPDRS Section II
- For Multiple Sclerosis: cerebellar function score of 3 or higher on EDSS-FS
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Istituti Clinici Scientifici Maugeri SpA
Bari, Italy, 70124
Actively Recruiting
2
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Actively Recruiting
3
Centro Riabilitativo Villa Beretta
Lecco, Italy, 23845
Actively Recruiting
4
Fondazione Don Carlo Gnocchi Onlus, IRCCS
Milan, Italy, 20148
Actively Recruiting
5
University of Modena and Reggio Emilia
Modena, Italy, 41121
Actively Recruiting
6
Istituto Neurologico Nazionale IRCCS Casimiro Mondino
Pavia, Italy, 27100
Actively Recruiting
Research Team
F
FRANCESCA BAGLIO, MD FRANCESCA BAGLIO, MD
CONTACT
F
FEDERICA ROSSETTO, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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