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

Effectiveness of TeleNEUROrehabilitation Systems for Timely and Personalized Interventions and Vigilant Care in Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial

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)

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Parkinson Disease; Neurologic Diseases, General
• Intervention / Treatment: Device: Telerehabilitation_TRsA; Device: Telerehabilitation_TRcA; Behavioral: Educational treatment

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FEDERICA ROSSETTO, PhD; Phone Number: 00390240308952; Email: frossetto@dongnocchi.it
• Study Contact Backup: Name: FRANCESCA BAGLIO, MD FRANCESCA BAGLIO, MD; Phone Number: 00390240308952; Email: fbaglio@dongnocchi.it

Study Locations

• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Istituti Clinici Scientifici Maugeri SpA
    • Contact: Stefania De Trane, MD; Email: stefania.detrane@icsmaugeri.it
  • Genova, Italy, 16132
    • Recruiting
    • Irccs Azienda Ospedaliera Universitaria San Martino
    • Contact: Angelo Schenone, MD; Email: angelo.schenone@unige.it
  • Lecco, Italy, 23845
    • Recruiting
    • Centro Riabilitativo Villa Beretta
    • Contact: Franco Molteni, MD; Email: franco56.molteni@gmail.com
  • Milan, Italy, 20148
    • Recruiting
    • Fondazione Don Carlo Gnocchi Onlus, IRCCS
    • Contact: Chiara Fanciullacci, Clinical Trial office; Phone Number: 00390240308952; Email: cfanciullacci@dongnocchi.it
    • Principal Investigator: Francesca Baglio, MD
    • Sub-Investigator: Federica Rossetto, PhD
  • Modena, Italy, 41121
    • Recruiting
    • University of Modena and Reggio Emilia
    • Contact: Giovanna Zamboni giovanna.zamboni@unimore.it, MD
  • Pavia, Italy, 27100
    • Recruiting
    • Istituto Neurologico Nazionale IRCCS Casimiro Mondino
    • Contact: Roberto Deicco, MD; Email: roberto.deicco@mondino.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRsA; Telerehabilitation (TR) single Approach - TRsA	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.; Other Names: Telemedicine; Digital Medicine
Experimental: TRcA; Telerehabilitation (TR) combined Approach - TRcA	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.; Other Names: Telemedicine; Digital medicine
Placebo Comparator: ET; Educational treatment - ET	Behavioral: Educational treatment; Home rehabilitation indications according to a conventional approach, customized according to the disease.; Other Names: Placebo treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dynamic and static balance measured by the Fullerton Advanced Balance Scale - FAB	The FAB Scale evaluates dynamic and static balance under different situations. The test consists of 10 items that assess different aspects of balance, such as standing with eyes closed, reaching forward, turning, stepping, and standing on one leg. Each activity is scored on a 5-point scale from 0 to 4, where higher scores indicate better performance. The total score ranges from 0 to 40, with a score of 25 or lower indicating balance disturbances.	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	The mDGI measures the capacity to adapt gait to complex tasks utilizing 8 tasks and 3 facets of performance (gait pattern score [0 -3], level of assistance [0 -2], and time level score [0 -3]). The total task score (range 0 -8) is calculated by summing the 3 performance facet scores for each task. Higher scores are indicative of better performance.	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	ABC is a 16-item questionnaire that measures an individual's confidence during activities without falling or experiencing a sense of unsteadiness. Each item is scored ranging from 0 to 100. Higher scores are indicative of higher perceived stability.	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	The FSS questionnaire contains nine items that rate the severity of your fatigue symptoms on daily-life activities. Each item is scored ranging from 1 to 7. Higher scores are indicative of higher perceived fatigue.	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	The 5xSTS asses functional lower limbs strength, transitional movements, balance, and fall risk. The scoring is based on the amount of time a patient is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test, the better the outcome of the test.	Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Change in mobility and leg function performance as measured by the Timed 25 Foot Walk - T25FW	The T25FW is a quantitative mobility and leg function performance test based on a timed 25 foot walk. The patient is directed to one end of a clearly marked 25 foot course and is instructed to walk 25 feet as quickly as possible. The time is calculated from the initiation of the instruction and ends when the patient has reached the 25 foot mark. The task is immediately administered again by having the patient walk back the same distance. The score is the average of the two completed trials.	Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Change in aerobic capacity and endurance as measured by the 6-Minute Walk Test - 6MWT	The 6MWT assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility	Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Change in global cognitive functioning as measured by the Montreal Cognitive Assessment test - MoCA	The MoCA test is a screening battery which also includes subtests to assess frontal functions such as set-shifting, abstraction and cognitive flexibility (MoCA total score range: 0-30). High scores are indicative of better general cognitive performance.	Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Change in visuoperceptual and attentional abilities as measured by the Trail Making Test - TMT parti A e B	The TMT is a neuropsychological test that involves visual scanning (TMT-A) and dual-task (TMT-B). The TMT is scored by how long it takes to complete each part of the test. High execution times indicate poor performance.	Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Change in visuoperceptual and attentional abilities as measured by the Symbol Digit Modalities Test - SDMT, Smith A., 1973; Nocentini U., 2006	The SDMT is a commonly used test to assess psychomotor speed. This paper-pencil measure involves a substitution task using a coding key with nine different abstract symbols, each paired with a numeral. Below the key, a series of these symbols is presented, and the participant is asked to write down the corresponding number for each symbol. The score consists of the number of correct substitutions within 90 seconds. Higher scores indicate better performance.	Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Change in the perceived level of disability as measured by the World Health Organization disability assessment schedule 2.0 - WHODAS 2.0	WHODAS 2.0 assesses the functioning and disability level in six domains (cognition, mobility, self-care, getting along, life activities, and participation in community activities) according to the International Classification of Functioning, Disability and Health (ICF). The summary scores for the WHODAS 2.0 will be obtained through 3 steps: 1) summing of item scores within each domain; 2) summing all six domain scores; 3) converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability and 100 = full disability).	Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Change in depressive symptoms as measured by the Beck Depression Inventory - BDI-II	The BDI-II is a 21-item questionnaire with each item rated on a 4-point scale (0-3). It is scored by summing ratings for each item (range 0-21). Higher scores indicate greater deflection of mood tone.	Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale - SUS	The SUS is a 10 items questionnaire evaluating the perceived usability of a technological system or device. Each item is scored on a Likert scale from 0 to 5, and the total score range from 0 to 100. Higher scores are indicative of higher perceived usability.	5 weeks after baseline
Technology Acceptance Model - TAM3	The TAM3 questionnaires evaluates the user acceptance of technology across 16 domains. Scoring is based on a Likert scale (from 1 = Strongly Disagree to 7 = Strongly Agree) or a 10-point Guttman scale. Higher scores are indicative of higher acceptance of technology.	5 weeks after baseline
Barthel Index	The Barthel Index is a scale used to measure a person's ability to perform basic activities of daily living (ADLs) independently. It evaluates 10 functions such as feeding, bathing, dressing, toileting, mobility, and stair climbing. Each activity is scored based on the level of assistance required, with a total score ranging from 0 (completely dependent) to 100 (completely independent).	Baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Multiple Sclerosis; Telemedicine; Parkinson's Disease; Telerehabilitation; Digital Medicine; ehealth; Chronic Neurological diseases
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Multiple Sclerosis; Sclerosis; Parkinson Disease; Nervous System Diseases
• Other Study ID Numbers: FIT4TeleNEURO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: October 2024- December 2036
• IPD Sharing Access Criteria: Contact the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No