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

NCT ID: NCT06009770

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-01-01

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.

Conditions

Post-stroke; Parkinson Disease; Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Telerehabilitation

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).

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Rehabilitation activities for PD and MS will be aimed at improving motor performance and balance using a task-oriented approach with Homing system technology; post-stroke patients will perform a home-based upper limb rehabilitation with the iCONE robotic device for robot-assisted neurorehabilitation of the upper limb.

Usual Care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Standard motor exercise training aimed at muscle mobilization and strengthening (MS and PD groups) or to mobilize and enhance motor control of upper limb functions (post-stroke group)

Interventions

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

Rehabilitation activities for PD and MS will be aimed at improving motor performance and balance using a task-oriented approach with Homing system technology; post-stroke patients will perform a home-based upper limb rehabilitation with the iCONE robotic device for robot-assisted neurorehabilitation of the upper limb.

Intervention Type: DEVICE

Usual Care

Standard motor exercise training aimed at muscle mobilization and strengthening (MS and PD groups) or to mobilize and enhance motor control of upper limb functions (post-stroke group)

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Ico Falck

UNKNOWN

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

FRANCESCA BAGLIO, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Don Carlo Gnocchi Onlus

Central Contacts

FRANCESCA BAGLIO, MD

Role: CONTACT

fbaglio@dongnocchi.it

00390240308952

FEDERICA ROSSETTO, PHD

Role: CONTACT

frossetto@dongnocchi.it

00390240308952

Related Links

https://www.dongnocchi.it/ricerca-scientifica/i-centri-irccs/irccs-s-maria-nascente-milano/caditer

internet page of Institution

https://caditer.dongnocchi.it/

internet page of Research Unit

Other Identifiers

TELENEURO@REHAB

Identifier Type: -

Identifier Source: org_study_id