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Completed

NCT Number: NCT05238389

AI-based Upper Limb Rehabilitation Therapy With MOTORE

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: MOTORE

Primary outcomes

  1. Agreement between the physiotherapists and the decision support system

    Time frame: Through the study, an average of 10 months

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

  2. System Usability Scale

    Time frame: After a 6-week robotic rehabilitation intervention

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

  3. Technology Acceptance Model (TAM)

    Time frame: After a 6-week robotic rehabilitation intervention

    It is a self-administered questionnaire to evaluate the acceptance of the provided.

    It comprises several questions rated on a 7-point likert scale.

  4. Likert for Satisfaction

    Time frame: After a 6-week robotic rehabilitation intervention

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

Secondary outcomes

  1. Changes in Fugl-meyer Assessment Upper Extremity motor functioning

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).

  2. Changes in Fugl-meyer Assessment Upper Extremity motor functioning

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).

  3. Changes in Box and Block test (BBT)

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    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.

  4. Changes in Box and Block test (BBT)

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    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.

  5. Changes in Action Research Arm Test (ARAT)

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    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.

  6. Changes in Action Research Arm Test (ARAT)

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    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.

  7. Change in Medical Research Council (MRC)

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    It is a validated measure of strength clinically measured. It ranges from 0, paralysis, to 5, normal strength.

  8. Change in Medical Research Council (MRC)

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    It is a validated measure of strength clinically measured. It ranges from 0, paralysis, to 5, normal strength.

  9. Change in Frenchay Arm Test

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    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).

  10. Change in Frenchay Arm Test

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    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).

  11. Change in Modified Ashworth Scale

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    It is a validated measure of spasticity. It ranges from 0 (normal) to 4 (rigid limb).

  12. Change in Modified Ashworth Scale

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    It is a validated measure of spasticity. It ranges from 0 (normal) to 4 (rigid limb).

  13. Changes in Motricity Index for upper extremity

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    It is a validated measure of upper limb strength. It ranges from 0 (worse) to 100 (normal strength).

  14. Changes in Motricity Index for upper extremity

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    It is a validated measure of upper limb strength. It ranges from 0 (worse) to 100 (normal strength).

  15. Changes in Numeric Rating Scale for pain

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    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).

  16. Changes in Numeric Rating Scale for pain

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    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).

  17. Changes in Neuropathic Pain 4 Questions (DN4)

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    It is a validated clinician-administered screening tool for neuropathic pain. It ranges from 0 to 10; higher values means higher neuropathic pain probability.

  18. Changes in Neuropathic Pain 4 Questions (DN4)

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    It is a validated clinician-administered screening tool for neuropathic pain. It ranges from 0 to 10; higher values means higher neuropathic pain probability.

  19. Changes in Modified Barthel Index

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    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.

  20. Changes in Modified Barthel Index

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    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.

  21. Changes in 36-Item Short Form Survey (SF-36)

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    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.

  22. Changes in the Duration Index.

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    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.

  23. Changes in the Duration Index.

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    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.

  24. Changes in Velocity_mean Index.

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    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.

  25. Changes in Velocity_mean Index.

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    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.

  26. Changes in the Length_tot Index

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    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);

  27. Changes in the Length_tot Index

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    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);

  28. Changes in the Score Index.

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    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.

  29. Changes in the Score Index.

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    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.

  30. Changes in the Work_tan Index.

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    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.

  31. Changes in the Work_tan Index.

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    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.

  32. Changes in kinetic parameters: Force (N) towards 8 targets

    Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention

    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.

  33. Changes in kinetic parameters: Force (N) towards 8 targets

    Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention

    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.

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

Intelligent Robot-mediated Therapy With the MOTORE Device

Acronym: iMotore

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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