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

NCT06009770 | Unknown

• 1 other identifier: TELENEURO@REHAB
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Keywords

Telerehabilitation; Digital medicine; Robotics; Chronic Neurological conditions

Outcome Measures

Primary Outcomes (1)

• 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)

  WHODAS 2.0 assesses the functioning and disability level in six domains (cognition, mobility, self-care, getting along, life activities, and participation in community activities) according to the International Classification of Functioning, Disability and Health (ICF). The summary scores for the WHODAS 2.0 will be obtained through 3 steps: 1) summing of item scores within each domain; 2) summing all six domain scores; 3) converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability and 100 = full disability).

  Baseline, post-treatment, and follow-up (2 months after the end of treatment)

Secondary Outcomes (14)

• 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

  Baseline, post-treatment, and follow-up (2 months after the end of treatment)

• 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

  Baseline, post-treatment, and follow-up (2 months after the end of treatment)

• 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

  Baseline, post-treatment, and follow-up (2 months after the end of treatment)

• 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

  Baseline, post-treatment, and follow-up (2 months after the end of treatment)

• 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

  Baseline, post-treatment, and follow-up (2 months after the end of treatment)

Other Outcomes (1)

• Change in connectivity indices as measured by brain Magnetic Resonance Imaging (MRI) (optional evaluation)

  Baseline, post-treatment, and follow-up (2 months after the end of treatment)

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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).

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

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual Care

Interventions

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

Telerehabilitation

Usual Care 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)

Usual Care

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• age between 25 and 85 years;
• preserved cognitive level at the Montreal Cognitive Assessment test (MoCA test \>17.36) (Conti et al., 2015);
• agreement to participate with the signature of the informed consent form;
• no rehabilitation program in place at the time of enrolment;
• stable drug treatment (last 3 months) with L-Dopa or dopamine agonists (PD group) and/or cortisone (MS group).

You may not qualify if:

• 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;
• 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);
• falls resulting in injuries or a number of falls ≤ 2 in the 6 months prior to recruitment (PD and MS groups).

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Fondazione Ico Falck: collaborator

Related Links

• internet page of Institution
• internet page of Research Unit

MeSH Terms

Conditions

Parkinson Disease; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• FRANCESCA BAGLIO, MD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

FRANCESCA BAGLIO, MD

CONTACT

00390240308952; fbaglio@dongnocchi.it

FEDERICA ROSSETTO, PHD

CONTACT

00390240308952; frossetto@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Trial intervention will not be blinded for clinicians or patients due to its nature. Conversely, clinical endpoints and data collection from clinical/psychological questionnaires will be blinded to examiners/assessors. The statistician conducting the data analysis will be masked for the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a single-blinded, randomized, two-treatment arms controlled clinical trial

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 24, 2023
• Study Start: September 1, 2023
• Primary Completion: May 29, 2024
• Study Completion: January 1, 2025
• Last Updated: August 24, 2023

Record last verified: 2023-07