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Taking people in ItalyNo phase

Tests home telerehabilitation for people with Parkinson disease or multiple sclerosis

Compares online rehabilitation exercise programs with educational treatment in people with Parkinson or multiple sclerosis.

Key facts

Who runs it
Fondazione Don Carlo Gnocchi ETS
Where
Bari, Genova, Lecco, Milan, Modena, and Pavia, ItalySee the 6 sites
Trial code
Registry title
TeleNEURO-Rehabilitation Systems for Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
Status
Recruiting
People taking part
300 people, planned
Started
23 Oct 2024
Planned end
30 Jun 2026
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Telerehabilitation_TRsA
  • Educational treatment
  • Telerehabilitation_TRcA
Record updated
3 March 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 25 to 85 with Parkinson's disease or multiple sclerosis who are not in a rehabilitation program. It compares home telerehabilitation with educational treatment.

Age
25 to 85 years
Sex
All sexes can join.
Disease stage
Parkinson's disease: probable PD by MDS criteria, stage 1 to 3 on the Hoehn & Yahr scale. Multiple sclerosis: diagnosed by the McDonald 2010 criteria, with an EDSS disability score of 4.5 or lower.
Earlier treatment
No rehabilitation program in place at enrolment. Drug treatment stable for the last three months: L-Dopa or dopamine agonists (Parkinson's), or Disease Modifying Therapies (multiple sclerosis).
Biomarker or test result
MoCA cognitive test score above 15.5.

Main reasons for not taking part

  • Other illnesses that make a safe home program impossible or cause clinical instability, such as severe orthopedic or severe cognitive problems
  • Major psychiatric problems or personality disorders
  • Severe problems with sight or hearing
  • Falls with injury, or more than 2 falls in the 6 months before recruitment
  • Pregnancy

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • falls resulting in injuries or more than 2 falls in the 6 months prior to recruitment (PD and MS groups)
  • presence of major psychiatric complications or personality disorders
  • presence of severe impairment of visual and/or acoustic perception
  • 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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 25 and 85 years old?

Where in Italy

  • Istituti Clinici Scientifici Maugeri SpABari, ItalyContact: Stefania De Trane, MDTaking people
  • IRCCS Azienda Ospedaliera Universitaria San MartinoGenova, ItalyContact: Angelo Schenone, MDTaking people
  • Centro Riabilitativo Villa BerettaLecco, ItalyContact: Franco Molteni, MDTaking people
  • Fondazione Don Carlo Gnocchi Onlus, IRCCSMilan, ItalyContact: Chiara Fanciullacci, Clinical Trial officeTaking people
  • University of Modena and Reggio EmiliaModena, ItalyContact: FRANCESCA BAGLIO, MD FRANCESCA BAGLIO, MDTaking people
  • Istituto Neurologico Nazionale IRCCS Casimiro MondinoPavia, ItalyContact: Roberto Deicco, MDTaking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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)

The 3 groups in the trial

  • TRsATreatment being tested

    Telerehabilitation (TR) single Approach - TRsA

    Treatment: Telerehabilitation_TRsA

  • TRcATreatment being tested

    Telerehabilitation (TR) combined Approach - TRcA

    Treatment: Telerehabilitation_TRcA

  • ETPlacebo, for comparison

    Educational treatment - ET

    Treatment: Educational treatment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effectiveness of TeleNEUROrehabilitation Systems for Timely and Personalized Interventions and Vigilant Care in Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
Plain-language title
Tests home telerehabilitation for people with Parkinson disease or multiple sclerosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06685744, who can take part
Record updated
3 March 2025