Clinical trial NCT06685744: TeleNEURO-Rehabilitation Systems for Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
Official title: Effectiveness of TeleNEUROrehabilitation Systems for Timely and Personalized Interventions and Vigilant Care in Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Multiple Sclerosis
Neurologic Diseases, General
Keywords: Telerehabilitation
Digital Medicine
Chronic Neurological diseases
Rehabilitation
Telemedicine
Parkinson&#39;s Disease
Multiple Sclerosis
ehealth
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Fondazione Don Carlo Gnocchi Onlus, IRCCS Milano
name: Fondazione Don Carlo Gnocchi Onlus, Centro S Maria della Provvidenza, Roma
name: Fondazione Mondino
name: Istituti Clinici Scientifici Maugeri SpA, IRCCS Bari
name: Istituti Clinici Scientifici Maugeri SpA, IRCCS Pavia
name: Istituti Clinici Scientifici Maugeri SpA, IRCCS Milano
name: Istituti Clinici Scientifici Maugeri SpA, IRCCS Montescano
name: Istituti Clinici Scientifici Maugeri SpA, IRCCS Telese
name: IRCCS Azienda Ospedaliera Universitaria San Martino - Genova
name: University of Modena and Reggio Emilia
name: Centro Riabilitativo Villa Beretta
First posted: 2024-11-12
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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 outcomes:
measure: Change in static and dynamic balance as measured by the Mini-Best Test
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Secondary outcomes:
measure: Change in dynamic and static balance measured by the Fullerton Advanced Balance Scale - FAB
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
measure: Change in dynamic balance as measured by the modified Dynamic Gait Index - mDGI
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
measure: Change in perceived stability during activities of daily living as measured by the Activities Balance Confidence scale - ABC
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
measure: Change in perceived fatigue during activities of daily living measured by the Fatigue Severity Scale - FSS
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
measure: Change in functional lower limbs strength as measured by the Five Times Sit to Stand Test - 5xSTS
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
measure: Change in mobility and leg function performance as measured by the Timed 25 Foot Walk - T25FW
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
measure: Change in aerobic capacity and endurance as measured by the 6-Minute Walk Test - 6MWT
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
measure: Change in global cognitive functioning as measured by the Montreal Cognitive Assessment test - MoCA
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
measure: Change in visuoperceptual and attentional abilities as measured by the Trail Making Test - TMT parti A e B
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
measure: Change in visuoperceptual and attentional abilities as measured by the Symbol Digit Modalities Test - SDMT, Smith A., 1973; Nocentini U., 2006
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
measure: Change in the perceived level of disability as measured by the World Health Organization disability assessment schedule 2.0 - WHODAS 2.0
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
measure: Change in depressive symptoms as measured by the Beck Depression Inventory - BDI-II
timeFrame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Other outcomes:
measure: System Usability Scale - SUS
timeFrame: 5 weeks after baseline
measure: Technology Acceptance Model - TAM3
timeFrame: 5 weeks after baseline
measure: Barthel Index
timeFrame: Baseline
Locations:
city: Bari
country: Italy
facility: Istituti Clinici Scientifici Maugeri SpA
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino
city: Lecco
country: Italy
facility: Centro Riabilitativo Villa Beretta
city: Milan
country: Italy
facility: Fondazione Don Carlo Gnocchi Onlus, IRCCS
city: Modena
country: Italy
facility: University of Modena and Reggio Emilia
city: Pavia
country: Italy
facility: Istituto Neurologico Nazionale IRCCS Casimiro Mondino
Study officials:
References: