Robotic Telerehabilitation of the Upper Limb in Stroke

Stroke Clinical Trial

— TELEREHAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05250934
• Other study ID #: FDG-Telerehab2021
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: August 8, 2021

Study information

• Verified date: February 2022
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 8, 2021
• Est. primary completion date: August 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Robotic rehabilitation
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.

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	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 4-week robotic rehabilitation intervention
Primary	Reliability of the remote evaluation of the Fugl-meyer Assessment Upper Extremity motor functioning (FMA)	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.	Before the intervention
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 4-week robotic rehabilitation intervention
Primary	Technology Acceptance Model (TAM)	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.	After a 4-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 4-week robotic rehabilitation intervention
Secondary	Changes in Fugl-meyer Assessment Upper Extremity motor functioning	t is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).	Before the intervention, after a 2-week robotic rehabilitation intervention
Secondary	Changes in Fugl-meyer Assessment - Sensory functioning	It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12 points (best).	Before the intervention, after a 2-week robotic rehabilitation intervention
Secondary	Changes in Fugl-meyer Assessment - Sensory functioning	It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12 points (best).	Before the intervention, after a 4-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 2-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 4-week robotic rehabilitation intervention
Secondary	Changes in the Independence Index	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.	Before the intervention, after a 2-week robotic rehabilitation intervention
Secondary	Changes in the Independence Index	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.	Before the intervention, after a 4-week robotic rehabilitation intervention
Secondary	Changes in the Area Index [m2]	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.	Before the intervention, after a 2-week robotic rehabilitation intervention
Secondary	Changes in the Area Index [m2]	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.	Before the intervention, after a 4-week robotic rehabilitation intervention
Secondary	Changes in the Path Index [mm]	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	Before the intervention, after a 2-week robotic rehabilitation intervention
Secondary	Changes in the Path Index [mm]	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	Before the intervention, after a 4-week robotic rehabilitation intervention
Secondary	Changes in the Movement Duration index [t]	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	Before the intervention, after a 2-week robotic rehabilitation intervention
Secondary	Changes in the Movement Duration index [t]	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	Before the intervention, after a 4-week robotic rehabilitation intervention
Secondary	Changes in the Peak speed index [m/s]	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	Before the intervention, after a 2-week robotic rehabilitation intervention
Secondary	Changes in the Peak speed index [m/s]	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	Before the intervention, after a 4-week robotic rehabilitation intervention
Secondary	Changes in the Mean speed index [m/s]	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	Before the intervention, after a 2-week robotic rehabilitation intervention
Secondary	Changes in the Mean speed index [m/s]	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	Before the intervention, after a 4-week robotic rehabilitation intervention
Secondary	Changes in the Smoothness index	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	Before the intervention, after a 2-week robotic rehabilitation intervention
Secondary	Changes in the Smoothness index	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	Before the intervention, after a 4-week robotic rehabilitation intervention
Secondary	Changes in the Hold index [m]	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.	Before the intervention, after a 2-week robotic rehabilitation intervention
Secondary	Changes in the Hold index [m]	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.	Before the intervention, after a 4-week robotic rehabilitation intervention
Secondary	Changes in the Displacement index [m]	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.	Before the intervention, after a 2-week robotic rehabilitation intervention
Secondary	Changes in the Displacement index [m]	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.	Before the intervention, after a 4-week robotic rehabilitation intervention
Secondary	Reliability of the remote evaluation of the Independence Index	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.	Before the intervention
Secondary	Reliability of the remote evaluation of the Area Index	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.	Before the intervention
Secondary	Reliability of the remote evaluation of the Path Index	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.	Before the intervention, after a 4-week robotic rehabilitation intervention
Secondary	Reliability of the remote evaluation of the Movement Duration index	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.	Before the intervention, after a 4-week robotic rehabilitation intervention
Secondary	Reliability of the remote evaluation of the Smoothness index	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.	Before the intervention
Secondary	Reliability of the remote evaluation of the Peak speed index	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.	Before the intervention
Secondary	Reliability of the remote evaluation of the Mean speed index	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.	Before the intervention
Secondary	Reliability of the remote evaluation of the Hold index	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.	Before the intervention
Secondary	Reliability of the remote evaluation of the Displacement index	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.	Before the intervention