Stroke, IschemicMOSENCT03530358
MOdularity for SEnsory Motor Control
A study testing Technology-aided rehabilitation and Conventional rehabilitation in people with Stroke, Ischemic and Upper Limb Injury, run by IRCCS San Camillo, Venezia, Italy at 2 sites in Italy.
Trial summary
For this project the investigators ask, how the activation and organization of muscle synergies may be disrupted by brain lesions, and whether it is possible to modify synergy activations by means of specific therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Upper Limb Injury, Rehabilitation
- What is being tested?
- Technology-aided rehabilitation and Conventional rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Dec 2014to 1 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of first stroke;
- a score between 1 and 3 (included) at the upper limb sub-item on the Italian version of the National Institute of Health stroke scale (IT - NIHSS) (Pezzella et al., 2009)
- a score higher than 6 out of 66 on the Fugl - Meyer upper extremity (F-M UE) scale (Fugl-Meyer et al., 1975).
Who cannot join
- the presence of a moderate cognitive decline defined as a Mini Mental State Examination (Folstein et al., 1975) score < 20/30 points;
- the finding of severe verbal comprehension deficit defined as a number of errors > 13 (Tau Points < 58/78) on the Token Test (Huber et al., 1984);
- evidence of apraxia and visuospatial neglect interfering with upper arm movements and manipulation of simple objects in all the directions within the visual field, as assessed through neurological examination;
- report in the patient's clinical history or evidence from the neurological examination of behavioural disturbances (i.e. delusions, aggressiveness and severe apathy/depression) that could affect compliance with the rehabilitation programs;
- non stabilised fractures;
- diagnosis of depression/delusion;
Show all 11Show fewer
- associated traumatic brain injury;
- drug resistant epilepsy;
- evidence of ideomotor apraxia;
- evidence of visuospatial neglect;
- severe impairment of verbal comprehension defined as a score higher than 13 errors on Token test (i.e. score<58 out of 78 Tau points).
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Fondazione Don Gnocchi Onlus
Milan
IRCCS San Camillo, Venezia, Italy
Venice, 30126
About this study
Official title: MOdularity for SEnsory Motor Control: Implications of Muscle Synergies in Motor Recovery After Stroke
For this project the investigators ask, how the activation and organization of muscle synergies may be disrupted by brain lesions, and whether it is possible to modify synergy activations by means of specific therapies. Will be investigated whether there is a relationship between post-stroke cortical plasticity and changes in synergy activations due to a therapy.
Read the detailed description
It has been widely recognized that neurorehabilitation can facilitate recovery of motor function after stroke. There has been increasing evidence suggesting that the execution of voluntary movement relies critically on the functional integration of the motor areas and the spinal circuitries. More precisely, it was suggested that the central nervous system may generate neural motor commands through a linear combination of spinal modules, each of which activates a group of muscles as a single unit (muscle synergy). The investigators hypothesize that descending motor cortical signals generate movements by combining and activating muscle synergies. With this background, the goal is to further improve the efficacy of rehabilitation utilizing knowledge on modular motor control. The investigators also seek to provide a better understanding of the links between brain activations and movements.
The project MO-SE has three aims, one primary and two secondary. The main primary aim is to test whether the use of virtual reality rehabilitation based therapies are superior in terms of clinical efficacy to conventional therapies (randomized clinica trial, RCT). The other two secondary aims of the project will be accomplished with further instrumental analysis in sub-samples of the group of patients enrolled for the RCT.
- Conditions
- Stroke, Ischemic, Upper Limb Injury, Rehabilitation
- Being tested
- Technology-aided rehabilitation, Conventional rehabilitation
- Keywords
- Muscle Synergies, MRI, Virtual Reality, Robotics
- Medical subject headings
- Ischemic Stroke, Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-aided rehabilitationDevice
Also called Virtual Reality Rehabilitation System (VRRS), Braccio di Ferro
VRRS involves performing different kinds of motor tasks with the patient holding a real manipulable object in their hands while interacting with a virtual scenario.
"Braccio di Ferro" task consists in center-out reaching movements and return. The subject is required to start from a central target, reach one of five peripheral targets arranged on a semi-circle with a 20 cm radius and then return to the central target.
Conventional rehabilitationBehavioural
The patients will be asked to perform a wide range of exercises, including: shoulder flexion-extension, abduction-adduction, internal-external rotation, circumduction, elbow flexion-extension, forearm pronation-supination, hand-digit motion. Standardized instructions and modalities will be followed when providing exercises to the patients in order to control for any variability in leading the therapy session due to the therapist.
| Study group | Role | What they receive |
|---|---|---|
| Technology-aided rehabilitation | Experimental | The technology-aided upper limb rehabilitation include reinforced feedback in virtual environment (RFVE), or robotic therapy. Receives: Device: Technology-aided rehabilitation |
| Conventional rehabilitation | Active comparator | The conventional upper limb rehabilitation program will be based on traditional rehabilitation techniques aimed at restoring upper limb motor functions. Receives: Behavioral: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Scale - Upper Extremity (construct: upper limb motor function)
Scale range scores: 0 - 66 points. Total summed score is reported with higher values representing a better outcome.
Measured: 20 days
Secondary outcomes (7)
Functional Independence Measure (FIM) (construct: measure for independence in the activities of daily living - ADLs)
Scale range scores: 18 - 126 points. Total summed score is reported with higher values representing a better outcome.
Measured: 20 days
Fugl-Meyer Assessment Scale - Range of Motion of Joints (construct: measure joints' passive range of motion)
Scale range scores: 0 - 44 points. Total summed score is reported with higher values representing a better outcome.
Measured: 20 days
Fugl-Meyer Assessment Scale - Sensory Function (construct: measure of residual sensory function in upper and lower limbs affected by paresis)
Scale range scores: 0 - 24 points. Total summed score is reported with higher values representing a better outcome.
Measured: 20 days
Fugl-Meyer Assessment Scale - Balance (construct: measure of impairment of standing and balance functions)
Scale range scores: 0 - 14 points. Total summed score is reported with higher values representing a better outcome.
Measured: 20 days
Reaching Performance Scale (construct: measure of the ability to reach targets in the frontal space of upper limb affected by paresis)
Scale range scores: 0 - 36 points. Total summed score is reported with higher values representing a better outcome.
Measured: 20 days
Modified Ashworth Scale (construct: measure of spasticity at the upper limb)
Scale range scores: 0 - 5 ranks. Total summed ranks are reported with higher values representing a worse outcome.
Measured: 20 days
Box and Block Test
Measure of gross motor function of the hand and upper limb
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Dec 2014
- Primary completion1 Dec 2018
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- Randomized Clinical Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi ETS
- Responsible party
- Principal investigator, Andrea Turolla, IRCCS San Camillo, Venezia, Italy
- Investigators
- Andrea Turolla, PhD, Principal investigator, IRCCS San Camillo, Venezia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530358
- Sponsor's protocol ID
- 2015.14
- Other IDs
- 16/GR-2011-02348942
- Acronym
- MOSE
- Status last verified
- Jun 2022
- First submitted
- 8 May 2018
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saltiel P, Wyler-Duda K, D'Avella A, Tresch MC, Bizzi E. Muscle synergies encoded within the spinal cord: evidence from focal intraspinal NMDA iontophoresis in the frog. J Neurophysiol. 2001 Feb;85(2):605-19. doi: 10.1152/jn.2001.85.2.605.
PubMed 11160497d'Avella A, Portone A, Fernandez L, Lacquaniti F. Control of fast-reaching movements by muscle synergy combinations. J Neurosci. 2006 Jul 26;26(30):7791-810. doi: 10.1523/JNEUROSCI.0830-06.2006.
PubMed 16870725Weiss T, Miltner WH, Liepert J, Meissner W, Taub E. Rapid functional plasticity in the primary somatomotor cortex and perceptual changes after nerve block. Eur J Neurosci. 2004 Dec;20(12):3413-23. doi: 10.1111/j.1460-9568.2004.03790.x.
PubMed 15610174Cheung VC, Piron L, Agostini M, Silvoni S, Turolla A, Bizzi E. Stability of muscle synergies for voluntary actions after cortical stroke in humans. Proc Natl Acad Sci U S A. 2009 Nov 17;106(46):19563-8. doi: 10.1073/pnas.0910114106. Epub 2009 Oct 30.
PubMed 19880747Cheung VC, Turolla A, Agostini M, Silvoni S, Bennis C, Kasi P, Paganoni S, Bonato P, Bizzi E. Muscle synergy patterns as physiological markers of motor cortical damage. Proc Natl Acad Sci U S A. 2012 Sep 4;109(36):14652-6. doi: 10.1073/pnas.1212056109. Epub 2012 Aug 20.
PubMed 22908288Mehrholz J, Hadrich A, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving generic activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD006876. doi: 10.1002/14651858.CD006876.pub3.
PubMed 22696362Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD008349. doi: 10.1002/14651858.CD008349.pub2.
PubMed 21901720Carpinella I, Cattaneo D, Abuarqub S, Ferrarin M. Robot-based rehabilitation of the upper limbs in multiple sclerosis: feasibility and preliminary results. J Rehabil Med. 2009 Nov;41(12):966-70. doi: 10.2340/16501977-0401.
PubMed 19841825Carpinella I, Cattaneo D, Bertoni R, Ferrarin M. Robot training of upper limb in multiple sclerosis: comparing protocols with or without manipulative task components. IEEE Trans Neural Syst Rehabil Eng. 2012 May;20(3):351-60. doi: 10.1109/TNSRE.2012.2187462.
PubMed 22623407Sacco RL, Wolf PA, Bharucha NE, Meeks SL, Kannel WB, Charette LJ, McNamara PM, Palmer EP, D'Agostino R. Subarachnoid and intracerebral hemorrhage: natural history, prognosis, and precursive factors in the Framingham Study. Neurology. 1984 Jul;34(7):847-54. doi: 10.1212/wnl.34.7.847.
PubMed 6539860Pezzella FR, Picconi O, De Luca A, Lyden PD, Fiorelli M. Development of the Italian version of the National Institutes of Health Stroke Scale: It-NIHSS. Stroke. 2009 Jul;40(7):2557-9. doi: 10.1161/STROKEAHA.108.534495. Epub 2009 Jun 11.
PubMed 19520997Keith RA, Granger CV, Hamilton BB, Sherwin FS. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil. 1987;1:6-18. No abstract available.
PubMed 3503663Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Huber W, Poeck K, Willmes K. The Aachen Aphasia Test. Adv Neurol. 1984;42:291-303. No abstract available.
PubMed 6209953
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOdularity for SEnsory Motor Control: Implications of Muscle Synergies in Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT03530358
- Acronym / sponsor ID
- MOSE / 2015.14
- Conditions
- Stroke, Ischemic, Upper Limb Injury, Rehabilitation
- Keywords
- Muscle Synergies, MRI, Virtual Reality, Robotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi ETS
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 21 May 2018 (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.
For this project the investigators ask, how the activation and organization of muscle synergies may be disrupted by brain lesions, and whether it is possible to modify synergy activations by means of specific therapies. Will be investigated whether there is a relationship between post-stroke cortical plasticity and changes in synergy activations due to a therapy.
Detailed description
It has been widely recognized that neurorehabilitation can facilitate recovery of motor function after stroke. There has been increasing evidence suggesting that the execution of voluntary movement relies critically on the functional integration of the motor areas and the spinal circuitries. More precisely, it was suggested that the central nervous system may generate neural motor commands through a linear combination of spinal modules, each of which activates a group of muscles as a single unit (muscle synergy). The investigators hypothesize that descending motor cortical signals generate movements by combining and activating muscle synergies. With this background, the goal is to further improve the efficacy of rehabilitation utilizing knowledge on modular motor control. The investigators also seek to provide a better understanding of the links between brain activations and movements.
The project MO-SE has three aims, one primary and two secondary. The main primary aim is to test whether the use of virtual reality rehabilitation based therapies are superior in terms of clinical efficacy to conventional therapies (randomized clinica trial, RCT). The other two secondary aims of the project will be accomplished with further instrumental analysis in sub-samples of the group of patients enrolled for the RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Technology-aided rehabilitation | Experimental | Device: Technology-aided rehabilitationThe technology-aided upper limb rehabilitation include reinforced feedback in virtual environment (RFVE), or robotic therapy. |
| Conventional rehabilitation | Active comparator | Behavioral: Conventional rehabilitationThe conventional upper limb rehabilitation program will be based on traditional rehabilitation techniques aimed at restoring upper limb motor functions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of first stroke;
- a score between 1 and 3 (included) at the upper limb sub-item on the Italian version of the National Institute of Health stroke scale (IT - NIHSS) (Pezzella et al., 2009)
- a score higher than 6 out of 66 on the Fugl - Meyer upper extremity (F-M UE) scale (Fugl-Meyer et al., 1975).
Key exclusion criteria (11 listed)
- the presence of a moderate cognitive decline defined as a Mini Mental State Examination (Folstein et al., 1975) score < 20/30 points;
- the finding of severe verbal comprehension deficit defined as a number of errors > 13 (Tau Points < 58/78) on the Token Test (Huber et al., 1984);
- evidence of apraxia and visuospatial neglect interfering with upper arm movements and manipulation of simple objects in all the directions within the visual field, as assessed through neurological examination;
- report in the patient's clinical history or evidence from the neurological examination of behavioural disturbances (i.e. delusions, aggressiveness and severe apathy/depression) that could affect compliance with the rehabilitation programs;
- non stabilised fractures;
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 |
|---|---|---|
| Technology-aided rehabilitationAlso: Virtual Reality Rehabilitation System (VRRS), Braccio di FerroVRRS involves performing different kinds of motor tasks with the patient holding a real manipulable object in their hands while interacting with a virtual scenario. "Braccio di Ferro" task consists in center-out reaching movements and return. The subject is required to start from a central target, reach one of five peripheral targets arranged on a semi-circle with a 20 cm radius and then return to the central target. | Device | Technology-aided rehabilitation |
| Conventional rehabilitationThe patients will be asked to perform a wide range of exercises, including: shoulder flexion-extension, abduction-adduction, internal-external rotation, circumduction, elbow flexion-extension, forearm pronation-supination, hand-digit motion. Standardized instructions and modalities will be followed when providing exercises to the patients in order to control for any variability in leading the therapy session due to the therapist. | Behavioural | Conventional rehabilitation |
Primary outcome
Fugl-Meyer Assessment Scale - Upper Extremity (construct: upper limb motor function)
Time frame: 20 days
Scale range scores: 0 - 66 points. Total summed score is reported with higher values representing a better outcome.
7 secondary outcomes
Functional Independence Measure (FIM) (construct: measure for independence in the activities of daily living - ADLs)
Time frame: 20 days
Fugl-Meyer Assessment Scale - Range of Motion of Joints (construct: measure joints' passive range of motion)
Time frame: 20 days
Fugl-Meyer Assessment Scale - Sensory Function (construct: measure of residual sensory function in upper and lower limbs affected by paresis)
Time frame: 20 days
Fugl-Meyer Assessment Scale - Balance (construct: measure of impairment of standing and balance functions)
Time frame: 20 days
Reaching Performance Scale (construct: measure of the ability to reach targets in the frontal space of upper limb affected by paresis)
Time frame: 20 days
Modified Ashworth Scale (construct: measure of spasticity at the upper limb)
Time frame: 20 days
Box and Block Test
Time frame: 20 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Background: PubMed 11160497Saltiel P, Wyler-Duda K, D'Avella A, Tresch MC, Bizzi E. Muscle synergies encoded within the spinal cord: evidence from focal intraspinal NMDA iontophoresis in the frog. J Neurophysiol. 2001 Feb;85(2):605-19. doi: 10.1152/jn.2001.85.2.605.
- Background: PubMed 16870725d'Avella A, Portone A, Fernandez L, Lacquaniti F. Control of fast-reaching movements by muscle synergy combinations. J Neurosci. 2006 Jul 26;26(30):7791-810. doi: 10.1523/JNEUROSCI.0830-06.2006.
- Background: PubMed 15610174Weiss T, Miltner WH, Liepert J, Meissner W, Taub E. Rapid functional plasticity in the primary somatomotor cortex and perceptual changes after nerve block. Eur J Neurosci. 2004 Dec;20(12):3413-23. doi: 10.1111/j.1460-9568.2004.03790.x.
- Background: PubMed 19880747Cheung VC, Piron L, Agostini M, Silvoni S, Turolla A, Bizzi E. Stability of muscle synergies for voluntary actions after cortical stroke in humans. Proc Natl Acad Sci U S A. 2009 Nov 17;106(46):19563-8. doi: 10.1073/pnas.0910114106. Epub 2009 Oct 30.
- Background: PubMed 22908288Cheung VC, Turolla A, Agostini M, Silvoni S, Bennis C, Kasi P, Paganoni S, Bonato P, Bizzi E. Muscle synergy patterns as physiological markers of motor cortical damage. Proc Natl Acad Sci U S A. 2012 Sep 4;109(36):14652-6. doi: 10.1073/pnas.1212056109. Epub 2012 Aug 20.
- Background: PubMed 22696362Mehrholz J, Hadrich A, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving generic activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD006876. doi: 10.1002/14651858.CD006876.pub3.
- Background: PubMed 21901720Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD008349. doi: 10.1002/14651858.CD008349.pub2.
- Background: PubMed 19841825Carpinella I, Cattaneo D, Abuarqub S, Ferrarin M. Robot-based rehabilitation of the upper limbs in multiple sclerosis: feasibility and preliminary results. J Rehabil Med. 2009 Nov;41(12):966-70. doi: 10.2340/16501977-0401.
- Background: PubMed 22623407Carpinella I, Cattaneo D, Bertoni R, Ferrarin M. Robot training of upper limb in multiple sclerosis: comparing protocols with or without manipulative task components. IEEE Trans Neural Syst Rehabil Eng. 2012 May;20(3):351-60. doi: 10.1109/TNSRE.2012.2187462.
- Background: PubMed 6539860Sacco RL, Wolf PA, Bharucha NE, Meeks SL, Kannel WB, Charette LJ, McNamara PM, Palmer EP, D'Agostino R. Subarachnoid and intracerebral hemorrhage: natural history, prognosis, and precursive factors in the Framingham Study. Neurology. 1984 Jul;34(7):847-54. doi: 10.1212/wnl.34.7.847.
- Background: PubMed 19520997Pezzella FR, Picconi O, De Luca A, Lyden PD, Fiorelli M. Development of the Italian version of the National Institutes of Health Stroke Scale: It-NIHSS. Stroke. 2009 Jul;40(7):2557-9. doi: 10.1161/STROKEAHA.108.534495. Epub 2009 Jun 11.
- Background: PubMed 3503663Keith RA, Granger CV, Hamilton BB, Sherwin FS. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil. 1987;1:6-18. No abstract available.
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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.
Andrea Turolla, PhD principal investigator
IRCCS San Camillo, Venezia, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-aided rehabilitation and Conventional rehabilitation in people with Stroke, Ischemic and Upper Limb Injury, run by IRCCS San Camillo, Venezia, Italy at 2 sites 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Fugl-Meyer Assessment Scale - Upper Extremity (construct: upper limb motor function) (time frame: 20 days). 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 NCT03530358, which also lists 28 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 8 Jun 2022.