TeleNEURO-Rehabilitation Systems for Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-85
SponsorFondazione Don Carlo Gnocchi Onlus
About this 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:
* 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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Telerehabilitation_TRsA
DeviceFrequency: 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
BehavioralHome rehabilitation indications according to a conventional approach, customized according to the disease.
Telerehabilitation_TRcA
DeviceFrequency: 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.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: TRsAExperimental treatment 1 intervention
Group B: TRcAExperimental treatment 1 intervention
Group C: ETPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)Secondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)Other outcomes
1
System Usability Scale - SUS
The SUS is a 10 items questionnaire evaluating the perceived usability of a technological system or device. Each item is scored on a Likert scale from 0 to 5, and the total score range from 0 to 100. Higher scores are indicative of higher perceived usability.
Time frame
5 weeks after baseline2
Technology Acceptance Model - TAM3
The TAM3 questionnaires evaluates the user acceptance of technology across 16 domains. Scoring is based on a Likert scale (from 1 = Strongly Disagree to 7 = Strongly Agree) or a 10-point Guttman scale. Higher scores are indicative of higher acceptance of technology.
Time frame
5 weeks after baseline3
Barthel Index
The Barthel Index is a scale used to measure a person's ability to perform basic activities of daily living (ADLs) independently. It evaluates 10 functions such as feeding, bathing, dressing, toileting, mobility, and stair climbing. Each activity is scored based on the level of assistance required, with a total score ranging from 0 (completely dependent) to 100 (completely independent).
Time frame
BaselineSponsors and contacts
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Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus, IRCCS Milano
Collaborator
Fondazione Don Carlo Gnocchi Onlus, Centro S Maria della Provvidenza, Roma
Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
Istituti Clinici Scientifici Maugeri SpA, IRCCS Bari
Collaborator
Istituti Clinici Scientifici Maugeri SpA, IRCCS Pavia
Collaborator
Istituti Clinici Scientifici Maugeri SpA, IRCCS Milano
Collaborator
Istituti Clinici Scientifici Maugeri SpA, IRCCS Montescano
Collaborator
Istituti Clinici Scientifici Maugeri SpA, IRCCS Telese
Collaborator
IRCCS Azienda Ospedaliera Universitaria San Martino - Genova
Collaborator
University of Modena and Reggio Emilia
Collaborator
Villa Beretta Rehabilitation Center
Collaborator
Source ClinicalTrials.gov