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

Overview

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)

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

Primary outcome measures

• Change in static and dynamic balance as measured by the Mini-Best Test [Time frame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)]

Secondary outcome measures (12)

• Change in dynamic and static balance measured by the Fullerton Advanced Balance Scale - FAB [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 6 centers

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

Identifiers

NCT: NCT06685744 · FIT4TeleNEURO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗