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Parkinson DiseaseFIT4TeleNEURONCT06685744

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

A study testing Telerehabilitation_TRsA, Educational treatment and Telerehabilitation_TRcA in people with Parkinson Disease and Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 6 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 … Read more about this study

Who is it for?
Ages 25 to 85 years
What is being tested?
Telerehabilitation_TRsA, Educational treatment and Telerehabilitation_TRcA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
6 sitesItaly
Study dates
23 Oct 2024to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

FRANCESCA BAGLIO, MD FRANCESCA BAGLIO, MD contact

00390240308952

fbaglio@dongnocchi.it

FEDERICA ROSSETTO, PhD contact

00390240308952

frossetto@dongnocchi.it

6 sites in 1 country

Italy6 sites, 6 recruiting
  • Istituti Clinici Scientifici Maugeri SpA

    Bari, 70124

    Stefania De Trane, MD, stefania.detrane@icsmaugeri.it

    Recruiting
  • IRCCS Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

    Angelo Schenone, MD, angelo.schenone@unige.it

    Recruiting
  • Centro Riabilitativo Villa Beretta

    Lecco, 23845

    Franco Molteni, MD, franco56.molteni@gmail.com

    Recruiting
  • Fondazione Don Carlo Gnocchi Onlus, IRCCS

    Milan, 20148

    Chiara Fanciullacci, Clinical Trial office, 00390240308952, cfanciullacci@dongnocchi.it

    Francesca Baglio, MD

    Recruiting
  • University of Modena and Reggio Emilia

    Modena, 41121

    Giovanna Zamboni giovanna.zamboni@unimore.it, MD

    Recruiting
  • Istituto Neurologico Nazionale IRCCS Casimiro Mondino

    Pavia, 27100

    Roberto Deicco, MD, roberto.deicco@mondino.it

    Recruiting

Other trials in Italy

About this study

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

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:

Read more
  • 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)
Being tested
Telerehabilitation_TRsA, Educational treatment, Telerehabilitation_TRcA
Keywords
Telerehabilitation, Digital Medicine, Chronic Neurological diseases, Rehabilitation, Telemedicine, Parkinson's Disease, Multiple Sclerosis, ehealth
Medical subject headings
Parkinson Disease, Multiple Sclerosis, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telerehabilitation_TRsADevice

    Also called Telemedicine, Digital Medicine

    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 treatmentBehavioural

    Also called Placebo treatment

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

  • Telerehabilitation_TRcADevice

    Also called Telemedicine, Digital medicine

    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.

Study groups in NCT06685744
Study groupRoleWhat they receive
TRsAExperimentalTelerehabilitation (TR) single Approach - TRsA
Receives: Device: Telerehabilitation_TRsA
TRcAExperimentalTelerehabilitation (TR) combined Approach - TRcA
Receives: Device: Telerehabilitation_TRcA
ETPlacebo comparatorEducational treatment - ET
Receives: Behavioral: Educational treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in static and dynamic balance as measured by the Mini-Best Test

    The Mini-BESTest aims to identify the disordered systems underlying the postural control responsible for poor functional balance. This tool is composed by 27 tasks (36 items in total) assessing bio-mechanical constraints, stability limits/verticality, anticipatory responses, postural responses, sensory orientation, and stability in gait. Each item is scored based on ordinal scale scoring from 0- 3 where 3 = best performances and 0 = worst performances. The total score is provided as a percentage. Higher scores are indicative of better performance.

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

Secondary outcomes (12)
  1. Change in dynamic and static balance measured by the Fullerton Advanced Balance Scale - FAB

    The FAB Scale evaluates dynamic and static balance under different situations. The test consists of 10 items that assess different aspects of balance, such as standing with eyes closed, reaching forward, turning, stepping, and standing on one leg. Each activity is scored on a 5-point scale from 0 to 4, where higher scores indicate better performance. The total score ranges from 0 to 40, with a score of 25 or lower indicating balance disturbances.

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

  2. Change in dynamic balance as measured by the modified Dynamic Gait Index - mDGI

    The mDGI measures the capacity to adapt gait to complex tasks utilizing 8 tasks and 3 facets of performance (gait pattern score [0 -3], level of assistance [0 -2], and time level score [0 -3]). The total task score (range 0 -8) is calculated by summing the 3 performance facet scores for each task. Higher scores are indicative of better performance.

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

  3. Change in perceived stability during activities of daily living as measured by the Activities Balance Confidence scale - ABC

    ABC is a 16-item questionnaire that measures an individual's confidence during activities without falling or experiencing a sense of unsteadiness. Each item is scored ranging from 0 to 100. Higher scores are indicative of higher perceived stability.

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

  4. Change in perceived fatigue during activities of daily living measured by the Fatigue Severity Scale - FSS

    The FSS questionnaire contains nine items that rate the severity of your fatigue symptoms on daily-life activities. Each item is scored ranging from 1 to 7. Higher scores are indicative of higher perceived fatigue.

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

  5. Change in functional lower limbs strength as measured by the Five Times Sit to Stand Test - 5xSTS

    The 5xSTS asses functional lower limbs strength, transitional movements, balance, and fall risk. The scoring is based on the amount of time a patient is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test, the better the outcome of the test.

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

  6. Change in mobility and leg function performance as measured by the Timed 25 Foot Walk - T25FW

    The T25FW is a quantitative mobility and leg function performance test based on a timed 25 foot walk. The patient is directed to one end of a clearly marked 25 foot course and is instructed to walk 25 feet as quickly as possible. The time is calculated from the initiation of the instruction and ends when the patient has reached the 25 foot mark. The task is immediately administered again by having the patient walk back the same distance. The score is the average of the two completed trials.

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

  7. Change in aerobic capacity and endurance as measured by the 6-Minute Walk Test - 6MWT

    The 6MWT assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

  8. Change in global cognitive functioning as measured by the Montreal Cognitive Assessment test - MoCA

    The MoCA test is a screening battery which also includes subtests to assess frontal functions such as set-shifting, abstraction and cognitive flexibility (MoCA total score range: 0-30). High scores are indicative of better general cognitive performance.

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

  9. Change in visuoperceptual and attentional abilities as measured by the Trail Making Test - TMT parti A e B

    The TMT is a neuropsychological test that involves visual scanning (TMT-A) and dual-task (TMT-B). The TMT is scored by how long it takes to complete each part of the test. High execution times indicate poor performance.

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

  10. Change in visuoperceptual and attentional abilities as measured by the Symbol Digit Modalities Test - SDMT, Smith A., 1973; Nocentini U., 2006

    The SDMT is a commonly used test to assess psychomotor speed. This paper-pencil measure involves a substitution task using a coding key with nine different abstract symbols, each paired with a numeral. Below the key, a series of these symbols is presented, and the participant is asked to write down the corresponding number for each symbol. The score consists of the number of correct substitutions within 90 seconds. Higher scores indicate better performance.

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

  11. Change in the perceived level of disability as measured by the World Health Organization disability assessment schedule 2.0 - WHODAS 2.0

    WHODAS 2.0 assesses the functioning and disability level in six domains (cognition, mobility, self-care, getting along, life activities, and participation in community activities) according to the International Classification of Functioning, Disability and Health (ICF). The summary scores for the WHODAS 2.0 will be obtained through 3 steps: 1) summing of item scores within each domain; 2) summing all six domain scores; 3) converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability and 100 = full disability).

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

  12. Change in depressive symptoms as measured by the Beck Depression Inventory - BDI-II

    The BDI-II is a 21-item questionnaire with each item rated on a 4-point scale (0-3). It is scored by summing ratings for each item (range 0-21). Higher scores indicate greater deflection of mood tone.

    Measured: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start23 Oct 2024
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06685744
Sponsor's protocol ID
FIT4TeleNEURO
Acronym
FIT4TeleNEURO
Status last verified
Nov 2024
First submitted
29 Oct 2024
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation_TRsA, Educational treatment and Telerehabilitation_TRcA in people with Parkinson Disease and Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 6 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact FRANCESCA BAGLIO, MD FRANCESCA BAGLIO, MD (00390240308952, fbaglio@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.

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