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Completed

NCT Number: NCT05250934

Robotic Telerehabilitation of the Upper Limb in Stroke

The goal of the study is to investigate the feasibility and the effects of a home-based upper-limb rehabilitation treatment (based on teleconsulting, telemonitoring, and robotic telerehabilitation using the robot Icone and integrated sensors) in patients with stroke.

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Key information

Conditions

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

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

About this study

Stroke is the second leading cause of death, the third leading cause of disability in the world and the leading cause of disability in the elderly. Rehabilitation treatment is a long and costly process, the effectiveness of which is supported by strong scientific evidence. In recent years, technology has spread to the rehabilitation field and, to date, the use of rehabilitation robotics, in addition to conventional treatment, is recommended by some stroke guidelines. The coronavirus pandemic has required a reorganization of rehabilitation services, but also an enhancement of technology as a tool in the rehabilitation field that can allow treatment in compliance with social distancing. Many scientific works have in fact confirmed the usefulness of these approaches to overcome the limits imposed by the pandemic, in particular for the treatment of disabilities in stroke patients.

The rehabilitation robot Icone (CE marked medical device, Class II-A, produced by Heaxel), is a device with certification for home use and therefore suitable for telerehabilitation. The proposed study aims to test the feasibility of rehabilitation treatment in a home setting based on a system of telecounseling, telemonitoring and robotic telerehabilitation using the robot Icone and integrated sensors for patients with stroke, to overcome the limits imposed by the COVID-19 pandemic.

Patients undergo robotic telerehabilitation treatment, carried out at home. The patient is supervised by a caregiver and, remotely, by a multidisciplinary team thanks to the use of webcams and sensors embedded in the robot. The evaluations, through clinical scales and instrumental evaluations, are carried out both in presence (at the enrollment and the end of the study) and remotely (before the first telerobotic rehabilitation session, in the middle and after the last telerobotic rehabilitation session). The study is included in the Regional Smart Specialization Strategy (S3 - Biorobotics for rehabilitation) for business & life continuity and co-financed by the European Union through LazioInnova

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ischemic or hemorrhagic stroke (verified by MRI or CT);
  • time since stroke onset > 3 months
  • cognitive abilities adequate to understand the experiments and the follow instructions
  • upper limb impairment (Fugl-Meyer Assessment - upper extremity score ≤58);
  • presence of a caregiver to supervise the treatment

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

Robotic rehabilitation

Device

The upper limb rehabilitation will be carried out with the planar rehabilitation robot Icone (a CE Class IIA medical device manufactured by Heaxel). The proposed exercises require the patient to move a cursor on the screen using the end-effector of the robot to reach specific points (planar reaching exercises). When the patient is able to perform these exercises independently, the robot assists the movement by minimizing the interaction force applied to the hand and limiting itself to acquiring the kinematic and dynamic parameters of the exercise, which are useful in determining the state of motor skills. Icone assist the subject by applying a force to his hand that helps him complete the task in the phases where the patient plans the movement correctly but is unable to complete it. As a result, the system will enable you to perform planar elbow and shoulder movements in active, passive, or active-assisted modes, with visual and acoustic feedback.

Other names: Icone (Heaxel)

Primary outcomes

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

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

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

  2. Reliability of the remote evaluation of the Fugl-meyer Assessment Upper Extremity motor functioning (FMA)

    Time frame: Before the intervention

    The value of the FMA obtained by means of online observation of the patient will be assessed in terms of reliability with the value obtained by means of direct observation, using the Intraclass Correlation Coefficient.

  3. System Usability Scale

    Time frame: After a 4-week robotic rehabilitation intervention

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

  4. Technology Acceptance Model (TAM)

    Time frame: After a 4-week robotic rehabilitation intervention

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

  5. Likert for Satisfaction

    Time frame: After a 4-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 2-week robotic rehabilitation intervention

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

  2. Changes in Fugl-meyer Assessment - Sensory functioning

    Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention

    It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12 points (best).

  3. Changes in Fugl-meyer Assessment - Sensory functioning

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

    It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12 points (best).

  4. Changes in Numeric Rating Scale for pain

    Time frame: Before the intervention, after a 2-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).

  5. Changes in Numeric Rating Scale for pain

    Time frame: Before the intervention, after a 4-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).

  6. Changes in the Independence Index

    Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represent the ratio between the minor and major axes of the ellipse best fitting the hand path in Cartesian coordinates during a circle drawing task.

  7. Changes in the Independence Index

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represent the ratio between the minor and major axes of the ellipse best fitting the hand path in Cartesian coordinates during a circle drawing task.

  8. Changes in the Area Index [m2]

    Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represent the area of the ellipse best fitting the hand path in Cartesian coordinates during a circle drawing task.

  9. Changes in the Area Index [m2]

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represent the area of the ellipse best fitting the hand path in Cartesian coordinates during a circle drawing task.

  10. Changes in the Path Index [mm]

    Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represents the mean distance of the travelled path from the ideal path during a point-to-point (reaching) task

  11. Changes in the Path Index [mm]

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represents the mean distance of the travelled path from the ideal path during a point-to-point (reaching) task

  12. Changes in the Movement Duration index [t]

    Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represents the mean time required to perform a movement during a point-to-point (reaching) task

  13. Changes in the Movement Duration index [t]

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represents the mean time required to perform a movement during a point-to-point (reaching) task

  14. Changes in the Peak speed index [m/s]

    Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represents the maximum value of the speed during a point-to-point (reaching) task

  15. Changes in the Peak speed index [m/s]

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represents the maximum value of the speed during a point-to-point (reaching) task

  16. Changes in the Mean speed index [m/s]

    Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represents the mean value of the speed during a point-to-point (reaching) task

  17. Changes in the Mean speed index [m/s]

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represents the mean value of the speed during a point-to-point (reaching) task

  18. Changes in the Smoothness index

    Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represents the ratio between the mean and the maximum value of the speed during a point-to-point (reaching) task

  19. Changes in the Smoothness index

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

    It is a kinematic index computed by means of the robotic device. It represents the ratio between the mean and the maximum value of the speed during a point-to-point (reaching) task

  20. Changes in the Hold index [m]

    Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention

    It is a kinetic index computed by means of the robotic device. It represents the mean value of the displacement of the end-effector of the robot when the patient is required to hold it in the middle of the workspace against centrifugal forces aimed to move the end-effector toward the targets. It decreases when the patient's strength increases.

  21. Changes in the Hold index [m]

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

    It is a kinetic index computed by means of the robotic device. It represents the mean value of the displacement of the end-effector of the robot when the patient is required to hold it in the middle of the workspace against centrifugal forces aimed to move the end-effector toward the targets. It decreases when the patient's strength increases.

  22. Changes in the Displacement index [m]

    Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention

    It is a kinetic index computed by means of the robotic device. It represents the mean value of the displacement of the end-effector of the robot when the patient is required to move it toward the eight targets against a centripetal force that try to hold it in the middle of the workspace.

    It increases when the patient's strength increases.

  23. Changes in the Displacement index [m]

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

    It is a kinetic index computed by means of the robotic device. It represents the mean value of the displacement of the end-effector of the robot when the patient is required to move it toward the eight targets against a centripetal force that try to hold it in the middle of the workspace.

    It increases when the patient's strength increases.

  24. Reliability of the remote evaluation of the Independence Index

    Time frame: Before the intervention

    The reliability of the index obtained by the patient using the robot at home will be assessed in terms of reliability with the value obtained by the patient using the robot in the clinic, using the Intraclass Correlation Coefficient.

  25. Reliability of the remote evaluation of the Area Index

    Time frame: Before the intervention

    The reliability of the index obtained by the patient using the robot at home will be assessed in terms of reliability with the value obtained by the patient using the robot in the clinic, using the Intraclass Correlation Coefficient.

  26. Reliability of the remote evaluation of the Path Index

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

    The reliability of the index obtained by the patient using the robot at home will be assessed in terms of reliability with the value obtained by the patient using the robot in the clinic, using the Intraclass Correlation Coefficient.

  27. Reliability of the remote evaluation of the Movement Duration index

    Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention

    The reliability of the index obtained by the patient using the robot at home will be assessed in terms of reliability with the value obtained by the patient using the robot in the clinic, using the Intraclass Correlation Coefficient.

  28. Reliability of the remote evaluation of the Smoothness index

    Time frame: Before the intervention

    The reliability of the index obtained by the patient using the robot at home will be assessed in terms of reliability with the value obtained by the patient using the robot in the clinic, using the Intraclass Correlation Coefficient.

  29. Reliability of the remote evaluation of the Peak speed index

    Time frame: Before the intervention

    The reliability of the index obtained by the patient using the robot at home will be assessed in terms of reliability with the value obtained by the patient using the robot in the clinic, using the Intraclass Correlation Coefficient.

  30. Reliability of the remote evaluation of the Mean speed index

    Time frame: Before the intervention

    The reliability of the index obtained by the patient using the robot at home will be assessed in terms of reliability with the value obtained by the patient using the robot in the clinic, using the Intraclass Correlation Coefficient.

  31. Reliability of the remote evaluation of the Hold index

    Time frame: Before the intervention

    The reliability of the index obtained by the patient using the robot at home will be assessed in terms of reliability with the value obtained by the patient using the robot in the clinic, using the Intraclass Correlation Coefficient.

  32. Reliability of the remote evaluation of the Displacement index

    Time frame: Before the intervention

    The reliability of the index obtained by the patient using the robot at home will be assessed in terms of reliability with the value obtained by the patient using the robot in the clinic, using the Intraclass Correlation Coefficient.It increases when the patient's strength increases.

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

Robotic Telerehabilitation: Feasibility of a Robotic Treatment of the Upper Limb With Remote Supervision in Patients With Stroke

Acronym: TELEREHAB

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 22, 2022
Registry last updated
Oct 15, 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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