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

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)

Conditions

• Parkinson Disease
• Multiple Sclerosis
• Neurologic Diseases, General

Interventions

DEVICE

Telerehabilitation_TRsA

Frequency: 5 weeks (4 sessions/week) of Telerehabilitation intervention provided according to a mixed model (3 asynchronous sessions + 1 synchronous session/week); Intensity: customized according to the patient's functional abilities (system's feedback); Time: 50 minutes/session; Type: exercises aimed at improving functional mobility and physical capacity according to a Task-oriented approach.

BEHAVIORAL

Educational treatment

Home rehabilitation indications according to a conventional approach, customized according to the disease.

DEVICE

Telerehabilitation_TRcA

Frequency: 5 weeks (4 sessions/week) of Telerehabilitation intervention provided according to a mixed model (3 asynchronous sessions + 1 synchronous session/week); Intensity: customized according to the patient's functional abilities (system's feedback); Time: 50 minutes/session; Type: a combination of exercises aimed at improving functional mobility and physical capacity according to a Task-oriented approach together with exercises aimed at recovering muscle strength (resistance) and improving endurance (endurance) using an Impairment-oriented approach.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus, IRCCS Milano

  collaborator UNKNOWN

• Fondazione Don Carlo Gnocchi Onlus, Centro S Maria della Provvidenza, Roma

  collaborator UNKNOWN

• Fondazione Mondino

  collaborator OTHER

• Istituti Clinici Scientifici Maugeri SpA, IRCCS Bari

  collaborator UNKNOWN

• Istituti Clinici Scientifici Maugeri SpA, IRCCS Pavia

  collaborator UNKNOWN

• Istituti Clinici Scientifici Maugeri SpA, IRCCS Milano

  collaborator UNKNOWN

• Istituti Clinici Scientifici Maugeri SpA, IRCCS Montescano

  collaborator UNKNOWN

• Istituti Clinici Scientifici Maugeri SpA, IRCCS Telese

  collaborator UNKNOWN

• IRCCS Azienda Ospedaliera Universitaria San Martino - Genova

  collaborator UNKNOWN

• University of Modena and Reggio Emilia

  collaborator OTHER

• Centro Riabilitativo Villa Beretta

  collaborator UNKNOWN

• Fondazione Don Carlo Gnocchi Onlus

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-23

Primary Completion

2026-05-30

Completion

2026-06-30

Countries

• Italy

Study Locations