TeleNEURO-Rehabilitation Systems for Neurodegenerative Conditions: the
Effectiveness of TeleNEUROrehabilitation Systems for Timely and Personalized Interventions and Vigilant Care in Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
What it found
No result yet.
What was tested
Treatment tested
- Telerehabilitation_TRsA
- Telerehabilitation_TRcA
Placebo
- Educational treatment
What it measured
Main measures
Change in static and dynamic balance as measured by the Mini-Best Test
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Walking and mobility
Other measures (12)
Change in dynamic and static balance measured by the Fullerton Advanced Balance Scale - FAB
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Walking and mobilityChange in dynamic balance as measured by the modified Dynamic Gait Index - mDGI
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Walking and mobilityChange in perceived stability during activities of daily living as measured by the Activities Balance Confidence scale - ABC
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Walking and mobilityChange in perceived fatigue during activities of daily living measured by the Fatigue Severity Scale - FSS
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
FatigueChange in functional lower limbs strength as measured by the Five Times Sit to Stand Test - 5xSTS
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Walking and mobilityPhysical functionChange in mobility and leg function performance as measured by the Timed 25 Foot Walk - T25FW
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Disability progressionWalking and mobilityChange in aerobic capacity and endurance as measured by the 6-Minute Walk Test - 6MWT
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Walking and mobilityPhysical functionChange in global cognitive functioning as measured by the Montreal Cognitive Assessment test - MoCA
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Thinking and memoryChange in visuoperceptual and attentional abilities as measured by the Trail Making Test - TMT parti A e B
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Thinking and memoryChange in visuoperceptual and attentional abilities as measured by the Symbol Digit Modalities Test - SDMT, Smith A., 1973; Nocentini U., 2006
Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
Thinking and memory
Who could take part
MS (type not specified) · 25 to 85
Show the full criteria
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).
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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)
Papers
Loading reviews and guidelines…
History
Started
Oct 2024
Main results due
May 2026
Finished
Jun 2026