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.
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
- Conditions the study is for
- Parkinson Disease, Multiple Sclerosis, Neurologic Diseases, General
- What is being tested?
- Telerehabilitation_TRsA, Educational treatment and Telerehabilitation_TRcA
- Type of treatment
- Medical device, Lifestyle or therapy programme
- 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.
6 sites in 1 country
Italy6 sites, 6 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| TRsA | Experimental | Telerehabilitation (TR) single Approach - TRsA Receives: Device: Telerehabilitation_TRsA |
| TRcA | Experimental | Telerehabilitation (TR) combined Approach - TRcA Receives: Device: Telerehabilitation_TRcA |
| ET | Placebo comparator | Educational treatment - ET Receives: Behavioral: Educational treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted12 Nov 2024
- Study start23 Oct 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi Onlus, IRCCS Milano, Fondazione Don Carlo Gnocchi Onlus, Centro S Maria della Provvidenza, Roma, IRCCS National Neurological Institute "C. Mondino" Foundation, Istituti Clinici Scientifici Maugeri SpA, IRCCS Bari, Istituti Clinici Scientifici Maugeri SpA, IRCCS Pavia, Istituti Clinici Scientifici Maugeri SpA, IRCCS Milano, Istituti Clinici Scientifici Maugeri SpA, IRCCS Montescano, Istituti Clinici Scientifici Maugeri SpA, IRCCS Telese, IRCCS Azienda Ospedaliera Universitaria San Martino - Genova, University of Modena and Reggio Emilia, Villa Beretta Rehabilitation Center
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of TeleNEUROrehabilitation Systems for Timely and Personalized Interventions and Vigilant Care in Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
- ClinicalTrials.gov ID
- NCT06685744
- Acronym / sponsor ID
- FIT4TeleNEURO / FIT4TeleNEURO
- Keywords
- Telerehabilitation, Digital Medicine, Chronic Neurological diseases, Rehabilitation, Telemedicine, Parkinson's Disease, Multiple Sclerosis, ehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi Onlus, IRCCS Milano, Fondazione Don Carlo Gnocchi Onlus, Centro S Maria della Provvidenza, Roma, IRCCS National Neurological Institute "C. Mondino" Foundation, Istituti Clinici Scientifici Maugeri SpA, IRCCS Bari, Istituti Clinici Scientifici Maugeri SpA, IRCCS Pavia, Istituti Clinici Scientifici Maugeri SpA, IRCCS Milano, Istituti Clinici Scientifici Maugeri SpA, IRCCS Montescano, Istituti Clinici Scientifici Maugeri SpA, IRCCS Telese, IRCCS Azienda Ospedaliera Universitaria San Martino - Genova, University of Modena and Reggio Emilia, Villa Beretta Rehabilitation Center
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRsA | Experimental | Device: Telerehabilitation_TRsATelerehabilitation (TR) single Approach - TRsA |
| TRcA | Experimental | Device: Telerehabilitation_TRcATelerehabilitation (TR) combined Approach - TRcA |
| ET | Placebo comparator | Behavioral: Educational treatmentEducational treatment - ET |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation_TRsAAlso: Telemedicine, Digital MedicineFrequency: 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. | Device | TRsA |
| Educational treatmentAlso: Placebo treatmentHome rehabilitation indications according to a conventional approach, customized according to the disease. | Behavioural | ET |
| Telerehabilitation_TRcAAlso: Telemedicine, Digital medicineFrequency: 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. | Device | TRcA |
Primary outcome
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)
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.
12 secondary outcomes
Change in dynamic and static balance measured by the Fullerton Advanced Balance Scale - FAB
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
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.