Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-31 @ 3:37 PM
Study NCT ID:
NCT05250934
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2022-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Telerehabilitation of the Upper Limb in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2022-02-11', 'studyFirstSubmitQcDate': '2022-02-11', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Fugl-meyer Assessment Upper Extremity motor functioning', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': 'It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).'}, {'measure': 'Reliability of the remote evaluation of the Fugl-meyer Assessment Upper Extremity motor functioning (FMA)', 'timeFrame': 'Before the intervention', 'description': '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.'}, {'measure': 'System Usability Scale', 'timeFrame': 'After a 4-week robotic rehabilitation intervention', 'description': 'It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.'}, {'measure': 'Technology Acceptance Model (TAM)', 'timeFrame': 'After a 4-week robotic rehabilitation intervention', 'description': '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.'}, {'measure': 'Likert for Satisfaction', 'timeFrame': 'After a 4-week robotic rehabilitation intervention', 'description': 'Satisfaction will be assessed using a 11-point likert scale. It ranges from 0 to 10. Higher scores mean higher satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Changes in Fugl-meyer Assessment Upper Extremity motor functioning', 'timeFrame': 'Before the intervention, after a 2-week robotic rehabilitation intervention', 'description': 't is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).'}, {'measure': 'Changes in Fugl-meyer Assessment - Sensory functioning', 'timeFrame': 'Before the intervention, after a 2-week robotic rehabilitation intervention', 'description': 'It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12 points (best).'}, {'measure': 'Changes in Fugl-meyer Assessment - Sensory functioning', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': 'It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12 points (best).'}, {'measure': 'Changes in Numeric Rating Scale for pain', 'timeFrame': 'Before the intervention, after a 2-week robotic rehabilitation intervention', 'description': '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).'}, {'measure': 'Changes in Numeric Rating Scale for pain', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': '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).'}, {'measure': 'Changes in the Independence Index', 'timeFrame': 'Before the intervention, after a 2-week robotic rehabilitation intervention', 'description': '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.'}, {'measure': 'Changes in the Independence Index', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': '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.'}, {'measure': 'Changes in the Area Index [m2]', 'timeFrame': 'Before the intervention, after a 2-week robotic rehabilitation intervention', 'description': '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.'}, {'measure': 'Changes in the Area Index [m2]', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': '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.'}, {'measure': 'Changes in the Path Index [mm]', 'timeFrame': 'Before the intervention, after a 2-week robotic rehabilitation intervention', 'description': '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'}, {'measure': 'Changes in the Path Index [mm]', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': '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'}, {'measure': 'Changes in the Movement Duration index [t]', 'timeFrame': 'Before the intervention, after a 2-week robotic rehabilitation intervention', 'description': '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'}, {'measure': 'Changes in the Movement Duration index [t]', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': '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'}, {'measure': 'Changes in the Peak speed index [m/s]', 'timeFrame': 'Before the intervention, after a 2-week robotic rehabilitation intervention', 'description': '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'}, {'measure': 'Changes in the Peak speed index [m/s]', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': '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'}, {'measure': 'Changes in the Mean speed index [m/s]', 'timeFrame': 'Before the intervention, after a 2-week robotic rehabilitation intervention', 'description': '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'}, {'measure': 'Changes in the Mean speed index [m/s]', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': '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'}, {'measure': 'Changes in the Smoothness index', 'timeFrame': 'Before the intervention, after a 2-week robotic rehabilitation intervention', 'description': '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'}, {'measure': 'Changes in the Smoothness index', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': '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'}, {'measure': 'Changes in the Hold index [m]', 'timeFrame': 'Before the intervention, after a 2-week robotic rehabilitation intervention', 'description': "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."}, {'measure': 'Changes in the Hold index [m]', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': "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."}, {'measure': 'Changes in the Displacement index [m]', 'timeFrame': 'Before the intervention, after a 2-week robotic rehabilitation intervention', 'description': "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.\n\nIt increases when the patient's strength increases."}, {'measure': 'Changes in the Displacement index [m]', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': "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.\n\nIt increases when the patient's strength increases."}, {'measure': 'Reliability of the remote evaluation of the Independence Index', 'timeFrame': 'Before the intervention', 'description': '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.'}, {'measure': 'Reliability of the remote evaluation of the Area Index', 'timeFrame': 'Before the intervention', 'description': '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.'}, {'measure': 'Reliability of the remote evaluation of the Path Index', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': '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.'}, {'measure': 'Reliability of the remote evaluation of the Movement Duration index', 'timeFrame': 'Before the intervention, after a 4-week robotic rehabilitation intervention', 'description': '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.'}, {'measure': 'Reliability of the remote evaluation of the Smoothness index', 'timeFrame': 'Before the intervention', 'description': '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.'}, {'measure': 'Reliability of the remote evaluation of the Peak speed index', 'timeFrame': 'Before the intervention', 'description': '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.'}, {'measure': 'Reliability of the remote evaluation of the Mean speed index', 'timeFrame': 'Before the intervention', 'description': '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.'}, {'measure': 'Reliability of the remote evaluation of the Hold index', 'timeFrame': 'Before the intervention', 'description': '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.'}, {'measure': 'Reliability of the remote evaluation of the Displacement index', 'timeFrame': 'Before the intervention', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Robotic rehabilitation', 'Telerehabilitation', 'Upper extremity'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '40269913', 'type': 'DERIVED', 'citation': 'Germanotta M, Mauro MC, Falchini F, Scotto Di Luzio F, Vollero L, Zollo L, Aprile IG. A robotic rehabilitation intervention in a home setting during the Covid-19 outbreak: a feasibility pilot study in patients with stroke. J Neuroeng Rehabil. 2025 Apr 24;22(1):93. doi: 10.1186/s12984-025-01633-9.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nPatients 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ischemic or hemorrhagic stroke (verified by MRI or CT);\n* time since stroke onset \\> 3 months\n* cognitive abilities adequate to understand the experiments and the follow instructions\n* upper limb impairment (Fugl-Meyer Assessment - upper extremity score ≤58);\n* presence of a caregiver to supervise the treatment\n\nExclusion Criteria:\n\n* fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);\n* inability to understand the instructions required for the study;\n* behavioral disorders that may influence therapeutic activity;\n* other orthopedic or neurological diseases\n* inability or unwillingness to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT05250934', 'acronym': 'TELEREHAB', 'briefTitle': 'Robotic Telerehabilitation of the Upper Limb in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': 'Robotic Telerehabilitation: Feasibility of a Robotic Treatment of the Upper Limb With Remote Supervision in Patients With Stroke', 'orgStudyIdInfo': {'id': 'FDG-Telerehab2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic group', 'description': "In the robotic group, each patient undergoes 20 upper limb robotic telerehabilitation sessions, each session lasting 1 hour. The frequency is 5 sessions/week. Each session is performed at the patient's home, with direct supervision of a caregiver and remote supervision of a physical therapist, using three webcams able to show (a) the frontal and (b) the sagittal plane of the patient, as well as (c) the monitor of the robot.", 'interventionNames': ['Device: Robotic rehabilitation']}], 'interventions': [{'name': 'Robotic rehabilitation', 'type': 'DEVICE', 'otherNames': ['Icone (Heaxel)'], 'description': '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.', 'armGroupLabels': ['Robotic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Irene Aprile, D, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Don Carlo Gnocchi Onlus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Neurorehabilitation Department, Neurologist, Principal Investigator', 'investigatorFullName': 'Irene Giovanna Aprile', 'investigatorAffiliation': 'Fondazione Don Carlo Gnocchi Onlus'}}}}