StrokeCopernicusNCT04364490
Rehabilitative Efficacy of a Visual Feedback Device for Locomotion of Post-stroke Patients
A study testing Copernicus noVF and Copernicis VF-Plus in people with Stroke, run by S.Anna Rehabilitation Institute at 1 site in Italy.
Trial summary
We tested the feasibility and efficacy of a novel body-weight support (BWS) gait training system with visual feedback, called Copernicus®. This computerized device provides highly comfortable, regular and repeatable locomotion in hemiplegic patients, training the ability to transfer weight loading alternately on both… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Copernicus noVF and Copernicis VF-Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 1 Dec 2019
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral stroke in the territory of middle cerebral artery, occurring at least 1 month before entry;
- ability to follow verbal instructions without severe cognitive impairment (Mini Mental State Evaluation, MMSE> 24);
- right-handed patients
- signature of informed consent.
Who cannot join
- bilateral impairment;
- presence of complete hemiplegia;
- history of traumatic injury ( e.g. fracture, joint dislocation with permanent dysmorphism after trauma) impairing the lower limb motor function;
- botulinum toxin injections or other medication influencing the function of the lower limbs;
- history of major affective disorders or alcohol abuse or history and/or clinical evidence of severe heart, lung, kidney, or liver diseases;
- inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Rehabilitative Efficacy of Copernicus®, a Visual Feedback Device for the Early Start to Locomotion of Post-stroke Patients
We tested the feasibility and efficacy of a novel body-weight support (BWS) gait training system with visual feedback, called Copernicus®. This computerized device provides highly comfortable, regular and repeatable locomotion in hemiplegic patients, training the ability to transfer weight loading alternately on both feet through visual real-time monitoring of gait parameters.
Read the detailed description
Gait disorders are very common in stroke patients (about 80%) increasing the risk of falls in performing daily activities and also reducing the global quality of life. Gait disorders in these patients are characterized by asymmetry in postural and weight distribution during quiet standing, as well as, by reduced gait speed, that is considered one of the most important outcome measure of locomotor recovery.
Restoring gait functions (speed, asymmetry and balance) after stroke is one of the major therapeutic goals in post-stroke rehabilitation and a plethora of recovering strategies have been proposed.
In this study we tested the feasibility and efficacy of a novel body-weight support (BWS) gait training system with visual feedback, called Copernicus®. This computerized device provides highly comfortable, regular and repeatable locomotion in hemiplegic patients, training the ability to transfer weight loading alternately on both feet through visual real-time monitoring of gait parameters Copernicus®, a sensory system for the early start of the locomotion appears as an elliptical cylinder of about 1 meter high on which two completely slideing positions are prepared by means if a guide fixed along the oval surface of the device. Each post has a support on which the patient's healthy side of the subject is placed, above which a brace for the support of the body is attached and weared by the patient in the verticalization; Front of the patient is a tablet that provides visual feedback during the exercises. The patient wears shoes on a pair of soles with piezo-resistive sensors that record for each foot the pressure exerted on the three areas of the foot (outer, inner and heel). The recorded data is then processed and transmitted to the tablet within a virtual reinforcement environment. The patient will be able to know his performance and achieved results and perceive them within a real scenario. The sensing pads measure the support times for each side and the number of changes. The device is so structured as to allow the simultaneous treatment of two patients.
- Conditions
- Stroke
- Being tested
- Copernicus noVF, Copernicis VF-Plus, Control group
- Keywords
- stroke, Gait Rehabilitation, Visual feedback, sensor feedback
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copernicus noVFDevice
Advanced gait training sessions by the computerized BWS system, named Copernicus®, without visual feedback.
Copernicis VF-PlusDevice
Advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance.
Control groupOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Experimental VF group | Experimental | Inpatients with a diagnosis of first-ever ischemic stroke in post acute phase, admitted for rehabilitation to S.Anna rehabilitation Institute.
The intervention consist of 2-h of rehabilitation daily sessions, five weekly over 6 weeks. During one hour of treatment, this group perform advanced gait training sessions by the computerized BWS system without visual feedback; during second hour of treatment, during the second hour of treatment patients are treated according to conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation. Receives: Device: Copernicus noVF |
| Experimental VF+ group | Experimental | Inpatients with a diagnosis of first-ever ischemic stroke in post acute phase, admitted for rehabilitation to S.Anna rehabilitation Institute.
The intervention consist of 2-h of rehabilitation daily sessions, five weekly over 6 weeks. During one hour of treatment, this group perform the same advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance; during second hour of treatment, during the second hour of treatment patients are treated according to conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation. Receives: Device: Copernicis VF-Plus |
| Control group | Active comparator | Inpatients with a diagnosis of first-ever ischemic stroke in post acute phase, admitted for rehabilitation to S.Anna rehabilitation Institute.
The intervention consist of 2-h of rehabilitation daily sessions, five weekly over 6 weeks. During one hour of treatment, this group perform conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation; during second hour of treatment, during the second hour of treatment patients are treated according to conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of an early rehabilitation and deambulation treatment performed using a visual feedback device.
To assess, motor abilities of lower limb, gait and balance, we use the Tinetti's test.
Measured: up to 6 weeks after the end of treatment
To evaluate the effects of an early rehabilitation and deambulation treatment performed using a visual feedback device.
The degree of disability during activities of daily living was assessed with the Barthel Index (BI).
Measured: up to 6 weeks after the end of treatment
Secondary outcomes (1)
To evaluate the effectiveness of a novel computerized BWS sensory feedback system (Copernicus®).
To evaluate the effectiveness of a novel computerized BWS sensory feedback system (Copernicus®) that provides information on gait performances by visual feedback extracted from wearable sensors we use the Fugl-Meyer Lower Extremities scale test (FM-LE).
Measured: 6 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Jun 2018
- Primary completion31 Dec 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- After a stroke this ability may become worse or completely lost. It was demonstrated that hemiparetic patients with poor trunk function at admission stayed longer in a rehabilitation ward compared to patients who had better initial trunk function and could walk longer distances with speed at discharge. The reinforcement of trunk exercises in addition to conventional therapy seems to have a beneficial effect on erection station balance and locomotion in post-stroke patients. In the light of current knowledge, early verticalization and reinforcement of trunk exercises improve posture, balance and mobility. In this study, consecutive patients at first ischemic stroke (documented with TAC / RMN) will be evaluated. Patients in the study group will receive 60 minutes of conventional neuromotor rehabilitation treatment and 60 minutes of treatment with Copernicus®. The control group will receive 120 minutes of conventional neuro motor rehabilitation treatment.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.Anna Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loris Pignolo, S.Anna Rehabilitation Institute
- Investigators
- Paolo Tonin, MD, Study director, S.Anna Rehabilitation Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364490
- Sponsor's protocol ID
- ISA COP062017
- Acronym
- Copernicus
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elsner B, Scholer A, Kon T, Mehrholz J. Walking with rhythmic auditory stimulation in chronic patients after stroke: A pilot randomized controlled trial. Physiother Res Int. 2020 Jan;25(1):e1800. doi: 10.1002/pri.1800. Epub 2019 Jun 24.
PubMed 31237045Mehrholz J, Pohl M, Kugler J, Elsner B. The Improvement of Walking Ability Following Stroke. Dtsch Arztebl Int. 2018 Sep 28;115(39):639-645. doi: 10.3238/arztebl.2018.0639.
PubMed 30375325Mehrholz J, Thomas S, Elsner B. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2017 Aug 17;8(8):CD002840. doi: 10.1002/14651858.CD002840.pub4.
PubMed 28815562Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-Assisted Training for Walking After Stroke: A Major Update of the Evidence. Stroke. 2017 Jun 16:STROKEAHA.117.018018. doi: 10.1161/STROKEAHA.117.018018. Online ahead of print. No abstract available.
PubMed 28626059Price R, Choy NL. Investigating the Relationship of the Functional Gait Assessment to Spatiotemporal Parameters of Gait and Quality of Life in Individuals With Stroke. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):256-264. doi: 10.1519/JPT.0000000000000173.
PubMed 29324509Gianella MG, Gath CF, Bonamico L, Olmos LE, Russo MJ. Prediction of Gait without Physical Assistance after Inpatient Rehabilitation in Severe Subacute Stroke Subjects. J Stroke Cerebrovasc Dis. 2019 Nov;28(11):104367. doi: 10.1016/j.jstrokecerebrovasdis.2019.104367. Epub 2019 Sep 10.
PubMed 31519458Belda-Lois JM, Mena-del Horno S, Bermejo-Bosch I, Moreno JC, Pons JL, Farina D, Iosa M, Molinari M, Tamburella F, Ramos A, Caria A, Solis-Escalante T, Brunner C, Rea M. Rehabilitation of gait after stroke: a review towards a top-down approach. J Neuroeng Rehabil. 2011 Dec 13;8:66. doi: 10.1186/1743-0003-8-66.
PubMed 22165907Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
PubMed 24505342Carozzo S, Serra S, Pignolo L, Tonin P, Cerasa A. The assessment of trunk recovery in stroke patients using 3D kinematic measures. Med Eng Phys. 2020 Apr;78:98-105. doi: 10.1016/j.medengphy.2020.01.013. Epub 2020 Feb 5.
PubMed 32035812Pignolo L, Serra S, Basta G, Carozzo S, Arcuri F, Pignataro LM, Ciancarelli I, Tonin P, Cerasa A. Data on a new neurorehabilitation approach targeting functional recovery in stroke patients. Data Brief. 2019 Oct 28;27:104685. doi: 10.1016/j.dib.2019.104685. eCollection 2019 Dec.
PubMed 31737755Cerasa A, Pignolo L, Gramigna V, Serra S, Olivadese G, Rocca F, Perrotta P, Dolce G, Quattrone A, Tonin P. Exoskeleton-Robot Assisted Therapy in Stroke Patients: A Lesion Mapping Study. Front Neuroinform. 2018 Jul 17;12:44. doi: 10.3389/fninf.2018.00044. eCollection 2018.
PubMed 30065642
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Rehabilitative Efficacy of Copernicus®, a Visual Feedback Device for the Early Start to Locomotion of Post-stroke Patients
- ClinicalTrials.gov ID
- NCT04364490
- Acronym / sponsor ID
- Copernicus / ISA COP062017
- Conditions
- Stroke
- Keywords
- stroke, Gait Rehabilitation, Visual feedback, sensor feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- S.Anna Rehabilitation InstituteUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 28 Apr 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.
We tested the feasibility and efficacy of a novel body-weight support (BWS) gait training system with visual feedback, called Copernicus®. This computerized device provides highly comfortable, regular and repeatable locomotion in hemiplegic patients, training the ability to transfer weight loading alternately on both feet through visual real-time monitoring of gait parameters.
Detailed description
Gait disorders are very common in stroke patients (about 80%) increasing the risk of falls in performing daily activities and also reducing the global quality of life. Gait disorders in these patients are characterized by asymmetry in postural and weight distribution during quiet standing, as well as, by reduced gait speed, that is considered one of the most important outcome measure of locomotor recovery.
Restoring gait functions (speed, asymmetry and balance) after stroke is one of the major therapeutic goals in post-stroke rehabilitation and a plethora of recovering strategies have been proposed.
In this study we tested the feasibility and efficacy of a novel body-weight support (BWS) gait training system with visual feedback, called Copernicus®. This computerized device provides highly comfortable, regular and repeatable locomotion in hemiplegic patients, training the ability to transfer weight loading alternately on both feet through visual real-time monitoring of gait parameters Copernicus®, a sensory system for the early start of the locomotion appears as an elliptical cylinder of about 1 meter high on which two completely slideing positions are prepared by means if a guide fixed along the oval surface of the device. Each post has a support on which the patient's healthy side of the subject is placed, above which a brace for the support of the body is attached and weared by the patient in the verticalization; Front of the patient is a tablet that provides visual feedback during the exercises. The patient wears shoes on a pair of soles with piezo-resistive sensors that record for each foot the pressure exerted on the three areas of the foot (outer, inner and heel). The recorded data is then processed and transmitted to the tablet within a virtual reinforcement environment. The patient will be able to know his performance and achieved results and perceive them within a real scenario. The sensing pads measure the support times for each side and the number of changes. The device is so structured as to allow the simultaneous treatment of two patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- After a stroke this ability may become worse or completely lost. It was demonstrated that hemiparetic patients with poor trunk function at admission stayed longer in a rehabilitation ward compared to patients who had better initial trunk function and could walk longer distances with speed at discharge. The reinforcement of trunk exercises in addition to conventional therapy seems to have a beneficial effect on erection station balance and locomotion in post-stroke patients. In the light of current knowledge, early verticalization and reinforcement of trunk exercises improve posture, balance and mobility. In this study, consecutive patients at first ischemic stroke (documented with TAC / RMN) will be evaluated. Patients in the study group will receive 60 minutes of conventional neuromotor rehabilitation treatment and 60 minutes of treatment with Copernicus®. The control group will receive 120 minutes of conventional neuro motor rehabilitation treatment.
| Arm | Type | Receives |
|---|---|---|
| Experimental VF group | Experimental | Device: Copernicus noVFInpatients with a diagnosis of first-ever ischemic stroke in post acute phase, admitted for rehabilitation to S.Anna rehabilitation Institute. The intervention consist of 2-h of rehabilitation daily sessions, five weekly over 6 weeks. During one hour of treatment, this group perform advanced gait training sessions by the computerized BWS system without visual feedback; during second hour of treatment, during the second hour of treatment patients are treated according to conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation. |
| Experimental VF+ group | Experimental | Device: Copernicis VF-PlusInpatients with a diagnosis of first-ever ischemic stroke in post acute phase, admitted for rehabilitation to S.Anna rehabilitation Institute. The intervention consist of 2-h of rehabilitation daily sessions, five weekly over 6 weeks. During one hour of treatment, this group perform the same advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance; during second hour of treatment, during the second hour of treatment patients are treated according to conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation. |
| Control group | Active comparator | Other: Control groupInpatients with a diagnosis of first-ever ischemic stroke in post acute phase, admitted for rehabilitation to S.Anna rehabilitation Institute. The intervention consist of 2-h of rehabilitation daily sessions, five weekly over 6 weeks. During one hour of treatment, this group perform conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation; during second hour of treatment, during the second hour of treatment patients are treated according to conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral stroke in the territory of middle cerebral artery, occurring at least 1 month before entry;
- ability to follow verbal instructions without severe cognitive impairment (Mini Mental State Evaluation, MMSE> 24);
- right-handed patients
- signature of informed consent.
Key exclusion criteria (6 listed)
- bilateral impairment;
- presence of complete hemiplegia;
- history of traumatic injury ( e.g. fracture, joint dislocation with permanent dysmorphism after trauma) impairing the lower limb motor function;
- botulinum toxin injections or other medication influencing the function of the lower limbs;
- history of major affective disorders or alcohol abuse or history and/or clinical evidence of severe heart, lung, kidney, or liver diseases;
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 |
|---|---|---|
| Copernicus noVFAdvanced gait training sessions by the computerized BWS system, named Copernicus®, without visual feedback. | Device | Experimental VF group |
| Copernicis VF-PlusAdvanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance. | Device | Experimental VF+ group |
| Control groupUsual care | Other | Control group |
Primary outcome
To evaluate the effects of an early rehabilitation and deambulation treatment performed using a visual feedback device.
Time frame: up to 6 weeks after the end of treatment
To assess, motor abilities of lower limb, gait and balance, we use the Tinetti's test.
To evaluate the effects of an early rehabilitation and deambulation treatment performed using a visual feedback device.
Time frame: up to 6 weeks after the end of treatment
The degree of disability during activities of daily living was assessed with the Barthel Index (BI).
1 secondary outcome
To evaluate the effectiveness of a novel computerized BWS sensory feedback system (Copernicus®).
Time frame: 6 weeks after the end of treatment
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 28 Apr 2020.
- Background: PubMed 31237045Elsner B, Scholer A, Kon T, Mehrholz J. Walking with rhythmic auditory stimulation in chronic patients after stroke: A pilot randomized controlled trial. Physiother Res Int. 2020 Jan;25(1):e1800. doi: 10.1002/pri.1800. Epub 2019 Jun 24.
- Background: PubMed 30375325Mehrholz J, Pohl M, Kugler J, Elsner B. The Improvement of Walking Ability Following Stroke. Dtsch Arztebl Int. 2018 Sep 28;115(39):639-645. doi: 10.3238/arztebl.2018.0639.
- Background: PubMed 28815562Mehrholz J, Thomas S, Elsner B. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2017 Aug 17;8(8):CD002840. doi: 10.1002/14651858.CD002840.pub4.
- Background: PubMed 28626059Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-Assisted Training for Walking After Stroke: A Major Update of the Evidence. Stroke. 2017 Jun 16:STROKEAHA.117.018018. doi: 10.1161/STROKEAHA.117.018018. Online ahead of print. No abstract available.
- Background: PubMed 29324509Price R, Choy NL. Investigating the Relationship of the Functional Gait Assessment to Spatiotemporal Parameters of Gait and Quality of Life in Individuals With Stroke. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):256-264. doi: 10.1519/JPT.0000000000000173.
- Background: PubMed 31519458Gianella MG, Gath CF, Bonamico L, Olmos LE, Russo MJ. Prediction of Gait without Physical Assistance after Inpatient Rehabilitation in Severe Subacute Stroke Subjects. J Stroke Cerebrovasc Dis. 2019 Nov;28(11):104367. doi: 10.1016/j.jstrokecerebrovasdis.2019.104367. Epub 2019 Sep 10.
- Background: PubMed 22165907Belda-Lois JM, Mena-del Horno S, Bermejo-Bosch I, Moreno JC, Pons JL, Farina D, Iosa M, Molinari M, Tamburella F, Ramos A, Caria A, Solis-Escalante T, Brunner C, Rea M. Rehabilitation of gait after stroke: a review towards a top-down approach. J Neuroeng Rehabil. 2011 Dec 13;8:66. doi: 10.1186/1743-0003-8-66.
- Background: PubMed 24505342Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
- Results publication: PubMed 32035812Carozzo S, Serra S, Pignolo L, Tonin P, Cerasa A. The assessment of trunk recovery in stroke patients using 3D kinematic measures. Med Eng Phys. 2020 Apr;78:98-105. doi: 10.1016/j.medengphy.2020.01.013. Epub 2020 Feb 5.
- Results publication: PubMed 31737755Pignolo L, Serra S, Basta G, Carozzo S, Arcuri F, Pignataro LM, Ciancarelli I, Tonin P, Cerasa A. Data on a new neurorehabilitation approach targeting functional recovery in stroke patients. Data Brief. 2019 Oct 28;27:104685. doi: 10.1016/j.dib.2019.104685. eCollection 2019 Dec.
- Results publication: PubMed 30065642Cerasa A, Pignolo L, Gramigna V, Serra S, Olivadese G, Rocca F, Perrotta P, Dolce G, Quattrone A, Tonin P. Exoskeleton-Robot Assisted Therapy in Stroke Patients: A Lesion Mapping Study. Front Neuroinform. 2018 Jul 17;12:44. doi: 10.3389/fninf.2018.00044. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Paolo Tonin, MD study director
S.Anna Rehabilitation Insitute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copernicus noVF and Copernicis VF-Plus in people with Stroke, run by S.Anna Rehabilitation Institute 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 4 inclusion and 6 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 28 Apr 2020. 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?
To evaluate the effects of an early rehabilitation and deambulation treatment performed using a visual feedback device. (time frame: up to 6 weeks after the end of treatment). The study lists 2 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 NCT04364490, which also lists 11 linked publications.
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 28 Apr 2020.