StrokeTELEREHABNCT05250934
Robotic Telerehabilitation of the Upper Limb in Stroke
A study testing Robotic rehabilitation in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 12 May 2021to 8 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center
Rome, 00168
About this study
Official title: Robotic Telerehabilitation: Feasibility of a Robotic Treatment of the Upper Limb With Remote Supervision in Patients With 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.
Read the detailed 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
- Conditions
- Stroke
- Being tested
- Robotic rehabilitation
- Keywords
- Robotic rehabilitation, Telerehabilitation, Upper extremity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic rehabilitationDevice
Also called Icone (Heaxel)
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.
| Study group | Role | What they receive |
|---|---|---|
| Robotic group | Experimental | 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. Receives: Device: Robotic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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.
Measured: Before the intervention
System Usability Scale
It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.
Measured: After a 4-week robotic rehabilitation intervention
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.
Measured: After a 4-week robotic rehabilitation intervention
Likert for Satisfaction
Satisfaction will be assessed using a 11-point likert scale. It ranges from 0 to 10. Higher scores mean higher satisfaction.
Measured: After a 4-week robotic rehabilitation intervention
Secondary outcomes (32)
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).
Measured: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in Fugl-meyer Assessment - Sensory functioning
It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12 points (best).
Measured: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in Fugl-meyer Assessment - Sensory functioning
It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12 points (best).
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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).
Measured: Before the intervention, after a 2-week robotic rehabilitation intervention
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).
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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.
Measured: Before the intervention, after a 2-week robotic rehabilitation intervention
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.
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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.
Measured: Before the intervention, after a 2-week robotic rehabilitation intervention
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.
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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
Measured: Before the intervention, after a 2-week robotic rehabilitation intervention
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
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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
Measured: Before the intervention, after a 2-week robotic rehabilitation intervention
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
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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
Measured: Before the intervention, after a 2-week robotic rehabilitation intervention
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
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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
Measured: Before the intervention, after a 2-week robotic rehabilitation intervention
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
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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
Measured: Before the intervention, after a 2-week robotic rehabilitation intervention
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
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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.
Measured: Before the intervention, after a 2-week robotic rehabilitation intervention
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.
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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.
Measured: Before the intervention, after a 2-week robotic rehabilitation intervention
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.
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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.
Measured: Before the intervention
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.
Measured: Before the intervention
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.
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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.
Measured: Before the intervention, after a 4-week robotic rehabilitation intervention
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.
Measured: Before the intervention
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.
Measured: Before the intervention
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.
Measured: Before the intervention
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.
Measured: Before the intervention
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.
Measured: Before the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start12 May 2021
- Primary completion8 Aug 2021
- Study completion8 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Giovanna Aprile, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Irene Aprile, D, PhD, Principal investigator, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250934
- Sponsor's protocol ID
- FDG-Telerehab2021
- Acronym
- TELEREHAB
- Status last verified
- Oct 2024
- First submitted
- 11 Feb 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40269913
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Telerehabilitation: Feasibility of a Robotic Treatment of the Upper Limb With Remote Supervision in Patients With Stroke
- ClinicalTrials.gov ID
- NCT05250934
- Acronym / sponsor ID
- TELEREHAB / FDG-Telerehab2021
- Conditions
- Stroke
- Keywords
- Robotic rehabilitation, Telerehabilitation, Upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 8 Aug 2021 (actual)
- Study completion
- 8 Aug 2021 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic group | Experimental | Device: Robotic rehabilitationIn 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic rehabilitationAlso: Icone (Heaxel)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. | Device | Robotic group |
Primary outcome
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).
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.
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.
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.
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.
32 secondary outcomes
Changes in Fugl-meyer Assessment Upper Extremity motor functioning
Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in Fugl-meyer Assessment - Sensory functioning
Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in Fugl-meyer Assessment - Sensory functioning
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Changes in Numeric Rating Scale for pain
Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in Numeric Rating Scale for pain
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Changes in the Independence Index
Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in the Independence Index
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Changes in the Area Index [m2]
Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in the Area Index [m2]
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Changes in the Path Index [mm]
Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in the Path Index [mm]
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Changes in the Movement Duration index [t]
Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in the Movement Duration index [t]
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Changes in the Peak speed index [m/s]
Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in the Peak speed index [m/s]
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Changes in the Mean speed index [m/s]
Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in the Mean speed index [m/s]
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Changes in the Smoothness index
Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in the Smoothness index
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Changes in the Hold index [m]
Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in the Hold index [m]
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Changes in the Displacement index [m]
Time frame: Before the intervention, after a 2-week robotic rehabilitation intervention
Changes in the Displacement index [m]
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Reliability of the remote evaluation of the Independence Index
Time frame: Before the intervention
Reliability of the remote evaluation of the Area Index
Time frame: Before the intervention
Reliability of the remote evaluation of the Path Index
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Reliability of the remote evaluation of the Movement Duration index
Time frame: Before the intervention, after a 4-week robotic rehabilitation intervention
Reliability of the remote evaluation of the Smoothness index
Time frame: Before the intervention
Reliability of the remote evaluation of the Peak speed index
Time frame: Before the intervention
Reliability of the remote evaluation of the Mean speed index
Time frame: Before the intervention
Reliability of the remote evaluation of the Hold index
Time frame: Before the intervention
Reliability of the remote evaluation of the Displacement index
Time frame: Before the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40269913Germanotta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Aprile, D, PhD principal investigator
Fondazione Don Carlo Gnocchi ETS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic rehabilitation in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fugl-meyer Assessment Upper Extremity motor functioning (time frame: Before the intervention, after a 4-week robotic rehabilitation intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05250934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.