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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 25 Years - 85 Years
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06009770
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fondazione Don Carlo Gnocchi Onlus
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

FRANCESCA BAGLIO, MD
Principal Investigator Affiliation Fondazione Don Carlo Gnocchi Onlus
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Post-stroke, Parkinson Disease, Multiple Sclerosis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: 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. Frequency: 5 weeks (4 sessions/week) of TR intervention provided according to a mixed model (3 asynchronous sessions + 1 synchronous, in-clinic session/week); Intensity: customized according to the patient's functional abilities (system's feedback); Time: 50 minutes/session; Type: according to the disease, TR protocols with a digital system (for MS and PD) or robotic tool (for post-stroke).

Active Comparator: Usual Care

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

Interventions

Device: - 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.

Behavioral: - 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)

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

FRANCESCA BAGLIO, MD

[email protected]

00390240308952

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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