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

Don Carlo Gnocchi Onlus Foundation

Status: Enrolling

Conditions: Multiple Sclerosis; Parkinson Disease; Neurologic Diseases, General

Treatments: Device: Telerehabilitation_TRsA; Device: Telerehabilitation_TRcA; Behavioral: Educational treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06685744

FIT4TeleNEURO

Details and patient eligibility

About

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)

Enrollment: 300 estimated patients

Sex: All

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 3 patient groups, including a placebo group

TRsA

Experimental group

Description:

Telerehabilitation (TR) single Approach - TRsA

Treatment:

Device: Telerehabilitation_TRsA

TRcA

Experimental group

Description:

Telerehabilitation (TR) combined Approach - TRcA

Treatment:

Device: Telerehabilitation_TRcA

ET

Placebo Comparator group

Description:

Educational treatment - ET

Treatment:

Behavioral: Educational treatment