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

Официальное название

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

Обзор

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)

Вмешательства

• Устройство 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.
• Поведенческое Educational treatment
  Home rehabilitation indications according to a conventional approach, customized according to the disease.
• Устройство 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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 6 центров

• 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

Идентификаторы

NCT: NCT06685744 · FIT4TeleNEURO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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