TeleNEURO-Rehabilitation Systems for Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
NCT ID: NCT06685744
Last Updated: 2025-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2024-10-23
2026-06-30
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TRsA
Telerehabilitation (TR) single Approach - TRsA
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.
TRcA
Telerehabilitation (TR) combined Approach - TRcA
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 endurance (endurance) using an Impairment-oriented approach.
ET
Educational treatment - ET
Educational treatment
Home rehabilitation indications according to a conventional approach, customized according to the disease.
Interventions
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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.
Educational treatment
Home rehabilitation indications according to a conventional approach, customized according to the disease.
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 endurance (endurance) using an Impairment-oriented approach.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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).
25 Years
85 Years
ALL
No
Sponsors
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Fondazione Don Carlo Gnocchi Onlus, IRCCS Milano
UNKNOWN
Fondazione Don Carlo Gnocchi Onlus, Centro S Maria della Provvidenza, Roma
UNKNOWN
Fondazione Mondino
OTHER
Istituti Clinici Scientifici Maugeri SpA, IRCCS Bari
UNKNOWN
Istituti Clinici Scientifici Maugeri SpA, IRCCS Pavia
UNKNOWN
Istituti Clinici Scientifici Maugeri SpA, IRCCS Milano
UNKNOWN
Istituti Clinici Scientifici Maugeri SpA, IRCCS Montescano
UNKNOWN
Istituti Clinici Scientifici Maugeri SpA, IRCCS Telese
UNKNOWN
IRCCS Azienda Ospedaliera Universitaria San Martino - Genova
UNKNOWN
University of Modena and Reggio Emilia
OTHER
Centro Riabilitativo Villa Beretta
UNKNOWN
Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Locations
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Istituti Clinici Scientifici Maugeri SpA
Bari, , Italy
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova, , Italy
Centro Riabilitativo Villa Beretta
Lecco, , Italy
Fondazione Don Carlo Gnocchi Onlus, IRCCS
Milan, , Italy
University of Modena and Reggio Emilia
Modena, , Italy
Istituto Neurologico Nazionale IRCCS Casimiro Mondino
Pavia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Giovanna Zamboni [email protected], MD
Role: primary
Other Identifiers
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FIT4TeleNEURO
Identifier Type: -
Identifier Source: org_study_id
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