AI-based Upper Limb Rehabilitation Therapy With MOTORE

NCT ID: NCT05238389

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-03-30

Brief Summary

Stroke is a common disease with a high disabling impact; it is the world's second leading cause of death and the third leading cause of disability. Robotic therapy has been proposed as a viable approach for the rehabilitation of the upper limb, as a way to increase the amount and the intensity of the therapy, and to standardize the treatment. However, robotic technologies have not yet been used to their full potential in terms of tailoring rehabilitation paths and monitoring the response to treatments. The main goal of the study is to use AI algorithms to (a) predict the recovery of the patients and (b) suggest exercises and parameters to improve the outcomes of the treatment.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic group

In the robotic group, patients will undergo a 30-session upper limb robotic rehabilitation using the device MOTORE.

Group Type: EXPERIMENTAL

AI-based upper limb robotic therapy

Intervention Type: DEVICE

Patients will be treated using MOTORE, a robotic device that allows passive, active, and active-assistive planar movements of the shoulder and elbow joints. The intervention will consist of 30 sessions, 1 per day and 5 per week. Therefore, each patient will be treated for 6 weeks

The parameters of the serious games will be proposed by a Decision Support System (DSS), based on an AI-based algorithm trained using data collected during a previous Randomized Controlled Trial.

The DSS will be fed, at the enrollment, with patient's demographics, clinical characteristics, clinical scales and kinematic/kinetic data measured by the robot during an evaluation session (unassisted reaching movements) and updated every 2 sessions with kinematic/kinetic data only, to tailor the treatment to the patient's current abilities.

The therapists will be free to use or not the suggested parameters, on the basis of their previous experience with the robot (over 3 years).

Interventions

AI-based upper limb robotic therapy

Patients will be treated using MOTORE, a robotic device that allows passive, active, and active-assistive planar movements of the shoulder and elbow joints. The intervention will consist of 30 sessions, 1 per day and 5 per week. Therefore, each patient will be treated for 6 weeks

The parameters of the serious games will be proposed by a Decision Support System (DSS), based on an AI-based algorithm trained using data collected during a previous Randomized Controlled Trial.

The DSS will be fed, at the enrollment, with patient's demographics, clinical characteristics, clinical scales and kinematic/kinetic data measured by the robot during an evaluation session (unassisted reaching movements) and updated every 2 sessions with kinematic/kinetic data only, to tailor the treatment to the patient's current abilities.

The therapists will be free to use or not the suggested parameters, on the basis of their previous experience with the robot (over 3 years).

Intervention Type: DEVICE

Other Intervention Names

MOTORE

Eligibility Criteria

Inclusion Criteria

• first ischemic or hemorrhagic stroke (verified by MRI or CT);
• time since stroke onset between 1 and 6 months (subacute phase)
• cognitive abilities adequate to understand the experiments and the follow instructions
• upper limb impairment (Fugl-Meyer Assessment - Upper Extremity score ≤58);

Exclusion Criteria

• fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
• inability to understand the instructions required for the study;
• behavioral disorders that may influence therapeutic activity;
• other orthopedic or neurological diseases
• inability or unwillingness to provide informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Irene Giovanna Aprile

Director of the Neurorehabilitation Department, Neurologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irene Aprile, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Don Carlo Gnocchi Onlus

Locations

Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center

Rome, , Italy

Countries

Italy

Other Identifiers

FDG-iMotore

Identifier Type: -

Identifier Source: org_study_id