AI-based Upper Limb Rehabilitation Therapy With MOTORE

NCT05238389 | Completed

• 1 other identifier: FDG-iMotore
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Agreement between the physiotherapists and the decision support system

  The number of times a physiotherapist refuses to accept the parameters proposed

  Through the study, an average of 10 months

• System Usability Scale

  It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.

  After a 6-week robotic rehabilitation intervention

• Technology Acceptance Model (TAM)

  It is a self-administered questionnaire to evaluate the acceptance of the provided. It comprises several questions rated on a 7-point likert scale.

  After a 6-week robotic rehabilitation intervention

• Likert for Satisfaction

  Satisfaction will be assessed using a 11-point likert scale. It ranges from 0 to 10. Higher scores mean higher satisfaction.

  After a 6-week robotic rehabilitation intervention

Secondary Outcomes (33)

• Changes in Fugl-meyer Assessment Upper Extremity motor functioning

  Before the intervention, after a 3-week robotic rehabilitation intervention

• Changes in Fugl-meyer Assessment Upper Extremity motor functioning

  Before the intervention, after a 6-week robotic rehabilitation intervention

• Changes in Box and Block test (BBT)

  Before the intervention, after a 3-week robotic rehabilitation intervention

• Changes in Box and Block test (BBT)

  Before the intervention, after a 6-week robotic rehabilitation intervention

• Changes in Action Research Arm Test (ARAT)

  Before the intervention, after a 3-week robotic rehabilitation intervention

Study Arms (1)

Robotic group

EXPERIMENTAL

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

Device: AI-based upper limb robotic therapy

Interventions

AI-based upper limb robotic therapy 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).

Also known as: MOTORE

Robotic group

Eligibility Criteria

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

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Irene Aprile, MD, PhD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Neurorehabilitation Department, Neurologist, Principal Investigator

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 14, 2022
• Study Start: June 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

IT (1)