Telerehabilitation Protocols With Digital and Robotic Tools for People With Chronic Neurological Disorders

Don Carlo Gnocchi Onlus Foundation

Status: Not yet enrolling

Conditions: Multiple Sclerosis; Post-stroke; Parkinson Disease

Treatments: Device: medical device "Homing" (TecnoBody); medical device "Icone" (Heaxel); Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06009770

TELENEURO@REHAB

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

Telerehabilitation

Experimental group

Description:

The TR intervention for people with PD, MS, and people post-stroke will be focused on addressing impairments and functional limitations that affect activities and participation in everyday life. 1. Frequency: 5 weeks (4 sessions/week) of TR intervention provided according to a mixed model (3 asynchronous sessions + 1 synchronous, in-clinic session/week); 2. Intensity: customized according to the patient's functional abilities (system's feedback); 3. Time: 50 minutes/session; 4. Type: according to the disease, TR protocols with a digital system (for MS and PD) or robotic tool (for post-stroke).

Treatment:

Device: medical device "Homing" (TecnoBody); medical device "Icone" (Heaxel)

Usual Care

Active Comparator group

Description:

Conventional rehabilitation exercises at home, customized according to the disease.

Treatment:

Behavioral: Usual Care