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

NCT06685744 | Recruiting DMC

• 1 other identifier: FIT4TeleNEURO
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Telerehabilitation; Digital Medicine; Chronic Neurological diseases; Rehabilitation; Telemedicine; Parkinson's Disease; Multiple Sclerosis; ehealth

Outcome Measures

Primary Outcomes (1)

• Change in static and dynamic balance as measured by the Mini-Best Test

  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.

  Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

Secondary Outcomes (12)

• Change in dynamic and static balance measured by the Fullerton Advanced Balance Scale - FAB

  Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

• Change in dynamic balance as measured by the modified Dynamic Gait Index - mDGI

  Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

• Change in perceived stability during activities of daily living as measured by the Activities Balance Confidence scale - ABC

  Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

• Change in perceived fatigue during activities of daily living measured by the Fatigue Severity Scale - FSS

  Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

• Change in functional lower limbs strength as measured by the Five Times Sit to Stand Test - 5xSTS

  Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

Other Outcomes (3)

• System Usability Scale - SUS

  5 weeks after baseline

• Technology Acceptance Model - TAM3

  5 weeks after baseline

• Barthel Index

  Baseline

Study Arms (3)

TRsA

EXPERIMENTAL

Telerehabilitation (TR) single Approach - TRsA

Device: Telerehabilitation_TRsA

TRcA

EXPERIMENTAL

Telerehabilitation (TR) combined Approach - TRcA

Device: Telerehabilitation_TRcA

ET

PLACEBO COMPARATOR

Educational treatment - ET

Behavioral: Educational treatment

Interventions

Telerehabilitation_TRsA DEVICE

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.

Also known as: Telemedicine, Digital Medicine

TRsA

Educational treatment BEHAVIORAL

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

Also known as: Placebo treatment

ET

Telerehabilitation_TRcA DEVICE

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.

Also known as: Telemedicine, Digital medicine

TRcA

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Fondazione Don Carlo Gnocchi Onlus, IRCCS Milano: collaborator
• Fondazione Don Carlo Gnocchi Onlus, Centro S Maria della Provvidenza, Roma: collaborator
• Fondazione Mondino: collaborator
• Istituti Clinici Scientifici Maugeri SpA, IRCCS Bari: collaborator
• Istituti Clinici Scientifici Maugeri SpA, IRCCS Pavia: collaborator
• Istituti Clinici Scientifici Maugeri SpA, IRCCS Milano: collaborator
• Istituti Clinici Scientifici Maugeri SpA, IRCCS Montescano: collaborator
• Istituti Clinici Scientifici Maugeri SpA, IRCCS Telese: collaborator
• IRCCS Azienda Ospedaliera Universitaria San Martino - Genova: collaborator
• University of Modena and Reggio Emilia: collaborator
• Centro Riabilitativo Villa Beretta: collaborator

Study Sites (6)

Istituti Clinici Scientifici Maugeri SpA

Bari, 70124, Italy

RECRUITING

IRCCS Azienda Ospedaliera Universitaria San Martino

Genova, 16132, Italy

RECRUITING

Centro Riabilitativo Villa Beretta

Lecco, 23845, Italy

RECRUITING

Fondazione Don Carlo Gnocchi Onlus, IRCCS

Milan, 20148, Italy

RECRUITING

University of Modena and Reggio Emilia

Modena, 41121, Italy

RECRUITING

Istituto Neurologico Nazionale IRCCS Casimiro Mondino

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Multiple Sclerosis; Nervous System Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

FRANCESCA BAGLIO, MD FRANCESCA BAGLIO, MD

CONTACT

00390240308952; fbaglio@dongnocchi.it

FEDERICA ROSSETTO, PhD

CONTACT

00390240308952; frossetto@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 12, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: October 2024- December 2036
• Access Criteria: Contact the principal investigator

Locations

IT (6)