Clinical trial NCT06009770: Telerehabilitation Protocols With Digital and Robotic Tools for People With Chronic Neurological Disorders
Official title: Development and Implementation of Telerehabilitation Protocols With Digital and Robotic Tools for the Continuity of Care of People With Chronic Neurological Disorders - TELENEURO@REHAB"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-stroke
Parkinson Disease
Multiple Sclerosis
Keywords: Telerehabilitation
Digital medicine
Robotics
Chronic Neurological conditions
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Fondazione Ico Falck
First posted: 2023-08-24
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a single-blinded, randomized, two-treatment arms controlled clinical trial
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test an innovative telerehabilitation protocol in people with Chronic Neurological Disorders (Parkinson's disease, Multiple Sclerosis, and post-stroke). The main questions it aims to answer are 1)the usability and acceptability of the system; 2)the level of safety of intervention; 3) the efficacy of the telerehabilitation protocol. Participants will be randomized (with an allocation ratio of 1:1) into either the experimental group (20 sessions of motor telerehabilitation with digital and robotic tools) or the active control group (20 motor rehabilitation sessions performed at home according to the usual care treatment procedure). Researchers will compare the experimental group and the active control group to see if the TR protocol with digital and robotic tools is effective in reducing the perceived level of disability.


Eligibility criteria: Inclusion Criteria:

1. diagnosis of chronic post-stroke condition with ischemic or haemorrhagic stroke injury occurred 4-6months before recruitment and with motor impairment of the upper limb \> 2 to the Medical Research Council scale (MRC); or diagnosis of probable PD according to MDS criteria (Postuma et al., 2015) in staging between 1.5 and 3 on the Hoehn \& Yahr scale (Goetz et al., 2004); or diagnosis of MS, RR-SP forms, according to the criteria of MC Donald 2010 (Polman et al., 2011) with disability level at the Expanded Disability Status Scale EDSS (Kurtzke, 1983) \< 6;
2. age between 25 and 85 years;
3. preserved cognitive level at the Montreal Cognitive Assessment test (MoCA test \>17.36) (Conti et al., 2015);
4. agreement to participate with the signature of the informed consent form;
5. no rehabilitation program in place at the time of enrolment;
6. stable drug treatment (last 3 months) with L-Dopa or dopamine agonists (PD group) and/or cortisone (MS group).

Exclusion Criteria:

1. 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);
2. presence of major psychiatric complications or personality disorders;
3. presence of severe impairment of visual and/or acoustic perception;
4. relapse ongoing/at least 3 months since the last relapse (MS group);
5. presence of "frequent" freezing as recorded at the administration of Section II (daily life activity) of the UPDRS (score ≥ 3) (PD group);
6. falls resulting in injuries or a number of falls ≤ 2 in the 6 months prior to recruitment (PD and MS groups).

Primary outcomes:
measure: Change in the perceived level of disability as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0, Federici et al., 2017)
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Secondary outcomes:
measure: Change in global cognitive functioning as measured by the Montreal Cognitive Assessment (MoCA test, Conti et al., 2015) in PD, MS, and post-stroke groups
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in visuoperceptual and attentional abilities as measured by the Trail Making Test (TMT part A and B, Giovagnoli et al., 1996) in PD, MS, and post-stroke groups
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in visuoperceptual and attentional abilities as measured by the and the Symbol Digit Modalities Test (SDMT; Smith A., 1973; Nocentini U., 2006) in PD, MS, and post-stroke groups
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in depressive symptoms as measured by the Beck Depression Inventory for Primary Care (BDI-PC, Steer et al., 1999) in PD, MS, and post-stroke groups
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in anxiety level as measured by the State-Trait Anxiety Inventory - Form Y (STAI - Y2; Spielberger, 1983; Pedrabissi & Santinello, 1989) in PD, MS, and post-stroke groups
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in gross manual dexterity as measured by the Box and Block Test (BBT; Desrosiers et al., 1994) in PD, MS, and post-stroke groups
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in finger dexterity as measured by the Nine Hole Peg Test (Feys et al., 2017) in PD and MS groups
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in dynamic balance as measured by the modified Dynamic Gait Index (mDGI; Anastasi et al., 2019) in PD and MS groups
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in static and dynamic balance as measured by the Mini-Best Test (Franchignoni et al., 2010) in PD and MS groups
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in perceived stability during activities of daily living as measured by the Activities Balance Confidence scale (ABC; Cattaneo et al., 2006; Franchignoni et al., 2014) in PD and MS groups
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in motor functionality as measured by the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS; Goetz et al., 2008) part III only in the PD group
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in the level of disability as measured by the EDSS (Kurtzke, 1983) only in the MS group
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in sensory-motor function of the upper limb as measured by the Fugl-Meyer Assessment - Upper Extremity (Fugl Meyer et al. 1975) only in post-stroke group
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
measure: Change in motor function of the upper limb as measured by the Action Research Arm Test (ARAT; Lyle, 1981) only in post-stroke group
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Other outcomes:
measure: Change in connectivity indices as measured by brain Magnetic Resonance Imaging (MRI) (optional evaluation)
timeFrame: Baseline, post-treatment, and follow-up (2 months after the end of treatment)
Locations:
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: FRANCESCA BAGLIO, MD
role: PRINCIPAL_INVESTIGATOR
References: