StrokeNCT04392453
Upper Limb Robotic Rehabilitation During COVID-19 Outbreak
A study testing Robotic therapy in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The COVID-19 outbreak requires a rapid re-shaping of the entire organization of the rehabilitation services. This includes the design and planning of appropriate rehabilitation settings, intervention and logistics for organizing space for patients. 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 therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 26 Oct 2020to 18 May 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
- first ischemic or hemorrhagic stroke (verified by MRI or CT);
- time latency within 6 months from stroke (subacute patients);
- age between 35-85 years;
- cognitive abilities adequate to understand the experiments and the follow instructions
- upper limb impairment (FMA-UE score ≤58);
- ability to give written consent;
- compliance with the study procedures.
Who cannot join
- history of recurrent stroke;
- inability to understand the instructions required for the study;
- fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
- severe deficits in visual acuity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Upper Limb Robotic Rehabilitation in Stroke Survivors Using a Portable Device During the COVID-19 Outbreak. A Feasibility Study
The COVID-19 outbreak requires a rapid re-shaping of the entire organization of the rehabilitation services. This includes the design and planning of appropriate rehabilitation settings, intervention and logistics for organizing space for patients.
The aims of this study are: (a) to evaluate the feasibility of the bedside use of a novel rehabilitation device for upper limb in patients with stroke; (b) to evaluate the motor and cognitive outcomes of the treatment; (c) to validate the instrumental outcomes provided by the device.
Read the detailed description
This study aims to:
- evaluate the feasibility of the bedside use of a novel portable rehabilitation device for upper limb in patients with stroke in an inpatient setting;
- assess motor and cognitive outcomes of the treatment;
- validate the instrumental outcomes provided by the device.
Forty subacute stroke patients with upper limb hemiplegia will be enrolled. Patients' upper limb will be treated with a novel portable robotic device (Icone, Heaxel). The robot will be transferred to each patient's room, where the rehabilitation session will be performed, thanks to the portability of the device. During the treatment, patients will execute "exergames" involving elbow flexion-extension, shoulder protraction-retraction, internal-external rotation, flexion-extension and abduction-adduction. The exercises will be selected among the available ones to train both motor and cognitive functions. The rehabilitation intervention will include 30 rehabilitation sessions, each lasting 45 minutes, three to five times a week. In addition to the upper limb treatment, patients will receive a rehabilitation treatment for the lower limbs.
For Aim 1, the usability and the acceptability of the device and the satisfaction with the treatment will be evaluated at the end of the rehabilitation intervention by means of the System Usability Scale (SUS), the Technology Acceptance Model (TAM), and the Likert scale, respectively.
For Aim 2, the clinical effect of the treatment with the robot will be investigated by means of the following scales, assessed both at baseline and at discharge: the Fugl-Meyer Assessment for the upper extremity (FMA-UE), the Motricity Index (MI), the Modified Ashworth Scale (MAS), the Modified Barthel Index (mBI), the Numeric Pain Rating Scale (NPRS), and the Montreal Cognitive Assessment (MoCA)
For Aim 3, at baseline, each patient will perform the kinematic and kinetic assessment provided by the robot twice, one day apart, to assess the reliability of the kinematic parameters provided by the robot; moreover, the kinematic and kinetics assessment will be performed every ten rehabilitation sessions, to analyze the responsiveness of the kinematic parameters and possible "plateau" in the recovery process.
- Conditions
- Stroke
- Being tested
- Robotic therapy
- Keywords
- rehabilitation, stroke, upper extremity, robotics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic therapyDevice
The treatment with the robot Icone will include 30 sessions, each session lasting 45 minutes, with a frequency from three to five times a week. The treatment will be provided in the patient's room. Patients will execute upper limb movement involving elbow flexion-extension, shoulder protraction-retraction, internal-external rotation, flexion-extension, and abduction-adduction. Visual and auditory feedback will be provided during the tasks. The exercises will train both motor and cognitive functions.
| Study group | Role | What they receive |
|---|---|---|
| Robotic therapy | Experimental | Upper limb robotic rehabilitation by means of the portable robot Icone. Receives: Device: Robotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS)
It is a tool for measuring the usability
Measured: After 30 rehabilitation sessions
Technology Acceptance Model (TAM)
It is a tool for measuring the acceptability.
Measured: After 30 rehabilitation sessions
Likert Scale
It is a tool for measuring the satisfaction.
Measured: After 30 rehabilitation sessions
Secondary outcomes (7)
Fugl-Meyer Assessment for upper extremity (FMA-UE)
The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
Measured: At baseline; after 30 rehabilitation sessions
Motricity Index for the upper extremity (MI-UE)
It is a clinical instrument for characterizing the strength of the paretic upper extremity following stroke.
Measured: At baseline; after 30 rehabilitation sessions
Modified Ashworth Scale (MAS)
It is a clinical instrument for characterizing upper limb spasticity. Shoulder, elbow and wrist spasticity will be assessed.
Measured: At baseline; after 30 session rehabilitation sessions
Numeric Pain Rating Scale (NPRS)
It is a unidimensional measure of pain intensity in adults.
Measured: At baseline; after 30 rehabilitation sessions
Modified Barthel Index (mBI)
It is a measure of independence in activities of daily living.
Measured: At baseline; after 30 rehabilitation sessions
Montreal Cognitive Assessment (MoCA)
It is a widely used screening assessment for detecting cognitive impairment.
Measured: At baseline; after 30 rehabilitation sessions
Kinematic parameters
The kinematics of the end-effector of the robot will be acquired during point-to-point tasks.
Measured: At baseline (twice, one day apart); after 10 rehabilitation sessions; after 20 rehabilitation sessions; after 30 rehabilitation sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start26 Oct 2020
- Primary completion18 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 22 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, MD, PhD, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392453
- Sponsor's protocol ID
- FDG_Icone
- Status last verified
- Feb 2022
- First submitted
- 15 May 2020
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Limb Robotic Rehabilitation in Stroke Survivors Using a Portable Device During the COVID-19 Outbreak. A Feasibility Study
- ClinicalTrials.gov ID
- NCT04392453
- Acronym / sponsor ID
- FDG_Icone
- Conditions
- Stroke
- Keywords
- rehabilitation, stroke, upper extremity, robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 18 May 2020 (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 COVID-19 outbreak requires a rapid re-shaping of the entire organization of the rehabilitation services. This includes the design and planning of appropriate rehabilitation settings, intervention and logistics for organizing space for patients.
The aims of this study are: (a) to evaluate the feasibility of the bedside use of a novel rehabilitation device for upper limb in patients with stroke; (b) to evaluate the motor and cognitive outcomes of the treatment; (c) to validate the instrumental outcomes provided by the device.
Detailed description
This study aims to:
- evaluate the feasibility of the bedside use of a novel portable rehabilitation device for upper limb in patients with stroke in an inpatient setting;
- assess motor and cognitive outcomes of the treatment;
- validate the instrumental outcomes provided by the device.
Forty subacute stroke patients with upper limb hemiplegia will be enrolled. Patients' upper limb will be treated with a novel portable robotic device (Icone, Heaxel). The robot will be transferred to each patient's room, where the rehabilitation session will be performed, thanks to the portability of the device. During the treatment, patients will execute "exergames" involving elbow flexion-extension, shoulder protraction-retraction, internal-external rotation, flexion-extension and abduction-adduction. The exercises will be selected among the available ones to train both motor and cognitive functions. The rehabilitation intervention will include 30 rehabilitation sessions, each lasting 45 minutes, three to five times a week. In addition to the upper limb treatment, patients will receive a rehabilitation treatment for the lower limbs.
For Aim 1, the usability and the acceptability of the device and the satisfaction with the treatment will be evaluated at the end of the rehabilitation intervention by means of the System Usability Scale (SUS), the Technology Acceptance Model (TAM), and the Likert scale, respectively.
For Aim 2, the clinical effect of the treatment with the robot will be investigated by means of the following scales, assessed both at baseline and at discharge: the Fugl-Meyer Assessment for the upper extremity (FMA-UE), the Motricity Index (MI), the Modified Ashworth Scale (MAS), the Modified Barthel Index (mBI), the Numeric Pain Rating Scale (NPRS), and the Montreal Cognitive Assessment (MoCA)
For Aim 3, at baseline, each patient will perform the kinematic and kinetic assessment provided by the robot twice, one day apart, to assess the reliability of the kinematic parameters provided by the robot; moreover, the kinematic and kinetics assessment will be performed every ten rehabilitation sessions, to analyze the responsiveness of the kinematic parameters and possible "plateau" in the recovery process.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic therapy | Experimental | Device: Robotic therapyUpper limb robotic rehabilitation by means of the portable robot Icone. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- first ischemic or hemorrhagic stroke (verified by MRI or CT);
- time latency within 6 months from stroke (subacute patients);
- age between 35-85 years;
- cognitive abilities adequate to understand the experiments and the follow instructions
- upper limb impairment (FMA-UE score ≤58);
Key exclusion criteria (4 listed)
- history of recurrent stroke;
- inability to understand the instructions required for the study;
- fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
- severe deficits in visual acuity.
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 therapyThe treatment with the robot Icone will include 30 sessions, each session lasting 45 minutes, with a frequency from three to five times a week. The treatment will be provided in the patient's room. Patients will execute upper limb movement involving elbow flexion-extension, shoulder protraction-retraction, internal-external rotation, flexion-extension, and abduction-adduction. Visual and auditory feedback will be provided during the tasks. The exercises will train both motor and cognitive functions. | Device | Robotic therapy |
Primary outcome
System Usability Scale (SUS)
Time frame: After 30 rehabilitation sessions
It is a tool for measuring the usability
Technology Acceptance Model (TAM)
Time frame: After 30 rehabilitation sessions
It is a tool for measuring the acceptability.
Likert Scale
Time frame: After 30 rehabilitation sessions
It is a tool for measuring the satisfaction.
7 secondary outcomes
Fugl-Meyer Assessment for upper extremity (FMA-UE)
Time frame: At baseline; after 30 rehabilitation sessions
Motricity Index for the upper extremity (MI-UE)
Time frame: At baseline; after 30 rehabilitation sessions
Modified Ashworth Scale (MAS)
Time frame: At baseline; after 30 session rehabilitation sessions
Numeric Pain Rating Scale (NPRS)
Time frame: At baseline; after 30 rehabilitation sessions
Modified Barthel Index (mBI)
Time frame: At baseline; after 30 rehabilitation sessions
Montreal Cognitive Assessment (MoCA)
Time frame: At baseline; after 30 rehabilitation sessions
Kinematic parameters
Time frame: At baseline (twice, one day apart); after 10 rehabilitation sessions; after 20 rehabilitation sessions; after 30 rehabilitation sessions
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 21 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
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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, MD, PhD principal investigator
IRCCS Fondazione Don Carlo Gnocchi
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 therapy 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 7 inclusion and 4 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 21 Feb 2022. 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?
System Usability Scale (SUS) (time frame: After 30 rehabilitation sessions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2022.