TeleNEURO-Rehabilitation Systems for Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial

Last updated: February 27, 2025
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Scar Tissue

Treatment

Educational treatment

Telerehabilitation_TRsA

Telerehabilitation_TRcA

Clinical Study ID

NCT06685744
FIT4TeleNEURO
  • Ages 25-85
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • diagnosis of probable PD according to MDS criteria (Postuma et al., 2015) in stagingbetween 1 and 3 on the Hoehn & Yahr scale (Goetz et al., 2004) or diagnosis of MSaccording to the criteria of MC Donald 2010 (Polman et al., 2011) with disabilitylevel 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

Exclusion Criteria:

  • presence of comorbidities that might prevent patients from undertaking a safe homeprogram or determining clinical instability (i.e., severe orthopedic or severecognitive 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 torecruitment (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).

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Educational treatment
Phase:
Study Start date:
October 23, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Istituti Clinici Scientifici Maugeri SpA

    Bari, 70124
    Italy

    Active - Recruiting

  • IRCCS Azienda Ospedaliera Universitaria San Martino

    Genova, 16132
    Italy

    Active - Recruiting

  • Centro Riabilitativo Villa Beretta

    Lecco, 23845
    Italy

    Active - Recruiting

  • Fondazione Don Carlo Gnocchi Onlus, IRCCS

    Milan, 20148
    Italy

    Active - Recruiting

  • University of Modena and Reggio Emilia

    Modena, 41121
    Italy

    Active - Recruiting

  • Istituto Neurologico Nazionale IRCCS Casimiro Mondino

    Pavia, 27100
    Italy

    Active - Recruiting

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