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

NCT06685744 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione Don Carlo Gnocchi ETS

Phase

Not applicable

Started

2024-10-23

Last updated

2025-03-03

Condition(s) studied

Parkinson DiseaseMultiple SclerosisNeurologic Diseases, General

Investigational drug(s) / intervention(s)

Telerehabilitation_TRsAEducational treatmentTelerehabilitation_TRcA

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.

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

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.

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

Sex

ALL

Min age

25 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: * 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). Exclusion Criteria: * 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); * 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 to recruitment (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).

Primary outcome measure(s)

Change in static and dynamic balance as measured by the Mini-Best Test — Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
The Mini-BESTest aims to identify the disordered systems underlying the postural control responsible for poor functional balance. This tool is composed by 27 tasks (36 items in total) assessing bio-mechanical constraints, stability limits/verticality, anticipatory responses, postural responses, sensory orientation, and stability in gait. Each item is scored based on ordinal scale scoring from 0- 3 where 3 = best performances and 0 = worst performances. The total score is provided as a percentage. Higher scores are indicative of better performance.

Trial sites (6)

Facility	City	Region	Status
Istituti Clinici Scientifici Maugeri SpA	Bari	Italy	Recruiting
IRCCS Azienda Ospedaliera Universitaria San Martino	Genova	Italy	Recruiting
Centro Riabilitativo Villa Beretta	Lecco	Italy	Recruiting
Fondazione Don Carlo Gnocchi Onlus, IRCCS	Milan	Italy	Recruiting
University of Modena and Reggio Emilia	Modena	Italy	Recruiting
Istituto Neurologico Nazionale IRCCS Casimiro Mondino	Pavia	Italy	Recruiting

More Fondazione Don Carlo Gnocchi ETS trials in Italy

Predictive Variables of Outcome in Subjects With Chronic Rachialgia Referred to Different Pathways of Physiotherapy. Recruiting

Home-Based Exergame Motor-Cognitive Rehabilitation for Traumatic Brain Injury Starting soon

Shared Interactive Book Reading in Preschool Children With Neurodevelopmental Disorders: Effects on Language Development and Reading Habits Active, not recruiting

National Database of the Virtual Institute of Cerebrovascular Diseases Recruiting

Implementation of a Registry for Patients With Stroke Recruiting

Other trials for the same condition

Gait and Balance Impairment in Rare and Very Rare Neurological Diseases Recruiting

PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort Recruiting

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) Active, not recruiting

ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease Active, not recruiting

Movement Improves Brain Health and Cognition in Parkinson's Disease Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06685744 on ClinicalTrials.gov ↗ ← All trials in Italy