RecruitingNot ApplicableNCT06685744

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

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

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Enrollment

300 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis Parkinson Disease Neurologic Diseases, General

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

Min Age: 25 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a remote digital rehabilitation program (delivered via technology at home) can improve function and quality of life in people with Parkinson's disease or multiple sclerosis (MS). **You may be eligible if...** - You have Parkinson's disease (diagnosed using standard criteria, stages 1–3) OR multiple sclerosis with mild-to-moderate disability - You are between 25 and 85 years old - Your thinking/memory is reasonably intact (MoCA score above 15.5) - You are not currently in any other rehabilitation program - Your medication has been stable for the past 3 months **You may NOT be eligible if...** - You have serious physical or thinking problems that would make home exercise unsafe - You have major psychiatric illness - You have severe vision or hearing impairment - You had 3 or more falls causing injuries in the past 6 months - You are pregnant - You have MS and are currently in a relapse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETelerehabilitation_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.

BEHAVIORALEducational treatment

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

DEVICETelerehabilitation_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.