AI-based Upper Limb Rehabilitation Therapy With MOTORE

Stroke Clinical Trial

— iMotore  

Official title:

Intelligent Robot-mediated Therapy With the MOTORE Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05238389
• Other study ID #: FDG-iMotore
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: February 2024
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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).

Locations

Country	Name	City	State
Italy	Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Changes in Fugl-meyer Assessment Upper Extremity motor functioning	It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in Fugl-meyer Assessment Upper Extremity motor functioning	It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in Box and Block test (BBT)	The BBT is a standard measure for evaluating manual dexterity. The participants grasp and transfer one-inch square blocks from one compartment to the other, transferring as many as possible. The number of blocks transferred from one side to the other within 1 min is recorded.	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in Box and Block test (BBT)	The BBT is a standard measure for evaluating manual dexterity. The participants grasp and transfer one-inch square blocks from one compartment to the other, transferring as many as possible. The number of blocks transferred from one side to the other within 1 min is recorded.	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in Action Research Arm Test (ARAT)	It is a valid measure of upper-extremity functional limitation. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance.	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in Action Research Arm Test (ARAT)	It is a valid measure of upper-extremity functional limitation. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance.	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Change in Medical Research Council (MRC)	It is a validated measure of strength clinically measured. It ranges from 0, paralysis, to 5, normal strength.	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Change in Medical Research Council (MRC)	It is a validated measure of strength clinically measured. It ranges from 0, paralysis, to 5, normal strength.	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Change in Frenchay Arm Test	The Frenchay Arm Test (FAT) is a measure of upper extremity proximal motor control and dexterity during activities of daily living in patients with upper limb impairments. The total scores range from 0 to 5 (normal performance).	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Change in Frenchay Arm Test	The Frenchay Arm Test (FAT) is a measure of upper extremity proximal motor control and dexterity during activities of daily living in patients with upper limb impairments. The total scores range from 0 to 5 (normal performance).	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Change in Modified Ashworth Scale	It is a validated measure of spasticity. It ranges from 0 (normal) to 4 (rigid limb).	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Change in Modified Ashworth Scale	It is a validated measure of spasticity. It ranges from 0 (normal) to 4 (rigid limb).	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in Motricity Index for upper extremity	It is a validated measure of upper limb strength. It ranges from 0 (worse) to 100 (normal strength).	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in Motricity Index for upper extremity	It is a validated measure of upper limb strength. It ranges from 0 (worse) to 100 (normal strength).	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in Numeric Rating Scale for pain	The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst pain imaginable).	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in Numeric Rating Scale for pain	The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst pain imaginable).	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in Neuropathic Pain 4 Questions (DN4)	It is a validated clinician-administered screening tool for neuropathic pain. It ranges from 0 to 10; higher values means higher neuropathic pain probability.	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in Neuropathic Pain 4 Questions (DN4)	It is a validated clinician-administered screening tool for neuropathic pain. It ranges from 0 to 10; higher values means higher neuropathic pain probability.	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in Modified Barthel Index	The modified is an ordinal scale used to measure performance in activities of daily living. It ranges from 0 to 100, with lower scores indicating increased disability.	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in Modified Barthel Index	The modified is an ordinal scale used to measure performance in activities of daily living. It ranges from 0 to 100, with lower scores indicating increased disability.	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in 36-Item Short Form Survey (SF-36)	The 36-Item Short Form Survey (SF-36) is a self-reported measure of health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.; The scores are: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health.; Moreover, two composite scores, i.e., the Physical Composite Score and the Mental Composite Score, both ranging from 0 to 100, will be considered.	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in the Duration Index.	The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Duration" is the time required to complete the task. It is measured in seconds.	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in the Duration Index.	The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Duration" is the time required to complete the task. It is measured in seconds.	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in Velocity_mean Index.	The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Velocity_mean" is the average velocity of the device during the test. It is measured in m/s.	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in Velocity_mean Index.	The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Velocity_mean" is the average velocity of the device during the test. It is measured in m/s.	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in the Length_tot Index	The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Length_tot" is the global length of the path travelled by the subject during center-out movements. It is measured in meters and it ranges from 0 (no movement) to 2.808 m (patient can fully perform the entire task);	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in the Length_tot Index	The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Length_tot" is the global length of the path travelled by the subject during center-out movements. It is measured in meters and it ranges from 0 (no movement) to 2.808 m (patient can fully perform the entire task);	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in the Score Index.	The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Score" is the mean of the ratios between the actual distance covered by the patients and the required distance to be travelled, computed for each required movement; it ranges from 0 (no movement) to 10 (the patient can fully perform the required task). It is a dimensionless index.	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in the Score Index.	The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Score" is the mean of the ratios between the actual distance covered by the patients and the required distance to be travelled, computed for each required movement; it ranges from 0 (no movement) to 10 (the patient can fully perform the required task). It is a dimensionless index.	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in the Work_tan Index.	The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Work_tan" is the amount of total work directed towards the target. It is measured in Joules.	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in the Work_tan Index.	The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Work_tan" is the amount of total work directed towards the target. It is measured in Joules.	Before the intervention, after a 6-week robotic rehabilitation intervention
Secondary	Changes in kinetic parameters: Force (N) towards 8 targets	The kinetics of the end-effector of the robot will be measured by the robot during reaching tasks performed by the patient against the device. The outcome will be the maximum values towards 8 targets.	Before the intervention, after a 3-week robotic rehabilitation intervention
Secondary	Changes in kinetic parameters: Force (N) towards 8 targets	The kinetics of the end-effector of the robot will be measured by the robot during reaching tasks performed by the patient against the device. The outcome will be the maximum values towards 8 targets.	Before the intervention, after a 6-week robotic rehabilitation intervention