StrokeRobocopNCT05288270
ROBOtic Care of Post-stroke Pain.
A study testing Aramis and Conventional therapy in people with Stroke, run by S.Anna Rehabilitation Institute.
Trial summary
In agreement to the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations that support the importance of physical functioning as core outcome for pain this randomized, double-blind, controlled clinical trial will be the pilot forming the rational basis for the assessment… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Aramis and Conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 30 Jul 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke-related hemiplegic arm;
- Hemiplegic subacute patients of any age at hospital discharge after stroke with functional magnetic resonance imaging (fMRI) scan of the area affected.
Who cannot join
- Bilateral impairment;
- Presence of aphasia;
- Presence of cognitive impairment;
- Stroke diagnosis without occurrence of hemiparesis of the upper limb.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: ROBOCOP (ROBOtic Care of Post-stroke Pain): Study Protocol for a Randomized, Double-blind Trial to Assess Robot-assisted Functional and Motor Recovery and Impact on Post-stroke Pain Development
In agreement to the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations that support the importance of physical functioning as core outcome for pain this randomized, double-blind, controlled clinical trial will be the pilot forming the rational basis for the assessment of the efficacy in the use of Robotic rehabilitation system to prevent chronic post stroke pain development. In fact, according to working hypothesis, proprioceptive inputs with high-intensive bilateral movement training of the hemiplegic arm can improve recovery and plasticity, thus preventing chronic post-stroke pain from occurring within the 3-6 months following stroke.
Read the detailed description
Stroke is one of the most frequent causes of death and disability worldwide. It is accompanied by impaired motor function of the upper extremities in over 69% of patients up to hemiplegia in the following 5 years in 56% of cases. This condition often is characterized by chronic post-stroke pain, difficult to manage and further worsening the patients' quality of life. Post-stroke pain occurs within 3-6 months and aberrant neuroplasticity in the first 3-4 weeks is implicated in its development. Robot-assisted neurorehabilitation using the Automatic Recovery Arm Motility Integrated System (ARAMIS) has proven efficacy in motor function recovery exploiting the movements and the strength of the unaffected arm to drive correct brain re-arrangement. Therefore, the rationale of the ROBOCOP (ROBOtic Care of Post-stroke pain) randomized, double-blind trial for the assessment of the impact of robot-assisted functional and motor recovery on post-stroke pain development is based on the prevention of anomalous plasticity and, hopefully, on the recovery of connectivity in the injured area.
To this aim, a total of 118 patients with hemiplegic arm due to stroke will be enrolled and randomly allocated with 1:1 ratio to ARAMIS or conventional neurorehabilitation group. After a baseline screening at hospital discharge during subacute period, ARAMIS or conventional rehabilitation will be performed for 8 weeks. The primary endpoint will consist in improvement of the Upper Extremity Subscale of the Fugl-Meyer Motor Assessment (FMA-UE), for the body functions of the upper extremity section domain; the Action Research Arm Test (ARAT) scores at 1, 2, 3 and 6 months after stroke. The secondary endpoints include no worsening of pain Visual Analogue Scale (VAS) and improvement of Barthel Index (BI) for activities of daily living and of Frenchay activities index (FAI) for physical activity, as well as improvement of magnetic resonance imaging (MRI) and electroencephalographic (EEG) parameters This is the first clinical trial investigating the efficacy of robot-assisted neurorehabilitation using ARAMIS on brain plasticity and re-organization and on post-stroke pain prevention. This study could remarkably improve the quality of life of stroke survivors.
- Conditions
- Stroke
- Being tested
- Aramis, Conventional therapy
- Keywords
- Robotic rehabilitation, Pain, stroke recovery
- Medical subject headings
- Stroke, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AramisDevice
ARAMIS is composed of two computer-controlled, symmetric and interacting exoskeletons able to compensate the inadequate strength and accuracy of the paretic arm movements, of which it measures residual motor function, and the effect of gravity during rehabilitation. It acts through motion capture of the movements of the unaffected arm. In so doing, the patient is able to replicate the movements of the healthy arm with the paretic arm in synchronous, asynchronous or active-assisted manner. The robot-assisted neurorehabilitation using ARAMIS consists in 60-min sessions for 8 weeks,structured as follows:
- 1 to 4 weeks: asynchronous exercises of repletion by the paretic arm of basic exercises 20 times for a total of 200 repetitions per session;
- 5 to 8 weeks: replaced by synchronous exercises (100/session) with active-assisted modality.
Conventional therapyOther
The control group will receive conventional rehabilitation consisting in passive mobilization of upper and lower limbs, coordination respiratory exercises, cardiovascular conditioning in the setting posture, conditioning in the upright posture, exercises for the trunk control.
| Study group | Role | What they receive |
|---|---|---|
| Aramis Group | Experimental | Consecutive patients, admitted to Sant' Anna Institute with diagnosis of stroke after hospital discharge that need motor and cognitive treatment and rehabilitation of neurological diseases. Receives: Device: Aramis |
| Conventional Group therapy | Active comparator | Consecutive patients, admitted to Sant' Anna Institute with diagnosis of stroke after hospital discharge that need motor and cognitive treatment and rehabilitation of neurological diseases. Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Motor Assessment - upper extremity (FMA-UE)
Improvement of Fugl-Meyer Motor Assessment (FMA-UE) scores. The score may range from 0 to 115. A higher score indicates better recovery
Measured: up to 6 months after the admission assessment.
Action Research Arm Test (ARAT)- Motor recovery scale
Improvement of Action Research Arm Test (ARAT) scores. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance
Measured: up to 6 months after the admission assessment.
Visual Analogue Scale (VAS) - Pain reduction
No worsening of Visual Analogue Scale (VAS). Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in patients who described their pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: up to 6 months after the admission assessment.
Barthel Index (BI)
Improvement of Barthel Index (BI). Scores on the BI may range from 0-100 points, with a maximum score of 100 points. Score from 80 to 100 indicates that the patient should be able to live indipendently
Measured: up to 6 months after the admission assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- This randomized, double-blind, single center trial will recruit subacute hemiplegic patients of any age with hemiparesis of the arm after stroke. The trial is designed as prospective, exploratory, interventional study without drug. The study does not request the use of drugs. This study protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.Anna Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288270
- Sponsor's protocol ID
- ISA-ROBOCOP
- Acronym
- Robocop
- Status last verified
- Mar 2022
- First submitted
- 10 Nov 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual partecipant data for all primary and secondary outcome measures will be made available.
Publications
Cerasa 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 30065642Pignolo 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 31737755Pignolo L. Robotics in neuro-rehabilitation. J Rehabil Med. 2009 Nov;41(12):955-60. doi: 10.2340/16501977-0434.
PubMed 19841823Calabro RS, Filoni S, Billeri L, Balletta T, Cannavo A, Militi A, Milardi D, Pignolo L, Naro A. Robotic Rehabilitation in Spinal Cord Injury: A Pilot Study on End-Effectors and Neurophysiological Outcomes. Ann Biomed Eng. 2021 Feb;49(2):732-745. doi: 10.1007/s10439-020-02611-z. Epub 2020 Sep 11.
PubMed 32918105Calabro RS, Pignolo L, Muller-Eising C, Naro A. Pain Perception in Disorder of Consciousness: A Scoping Review on Current Knowledge, Clinical Applications, and Future Perspective. Brain Sci. 2021 May 20;11(5):665. doi: 10.3390/brainsci11050665.
PubMed 34065349Colizzi L, Lidonnici A, Pignolo L. The ARAMIS project: a concept robot and technical design. J Rehabil Med. 2009 Nov;41(12):1011-101. doi: 10.2340/16501977-0407.
PubMed 19841834Gandolfi M, Vale N, Posteraro F, Morone G, Dell'orco A, Botticelli A, Dimitrova E, Gervasoni E, Goffredo M, Zenzeri J, Antonini A, Daniele C, Benanti P, Boldrini P, Bonaiuti D, Castelli E, Draicchio F, Falabella V, Galeri S, Gimigliano F, Grigioni M, Mazzon S, Molteni F, Petrarca M, Picelli A, Senatore M, Turchetti G, Giansanti D, Mazzoleni S; Italian Consensus Conference on Robotics in Neurorehabilitation (CICERONE). State of the art and challenges for the classification of studies on electromechanical and robotic devices in neurorehabilitation: a scoping review. Eur J Phys Rehabil Med. 2021 Oct;57(5):831-840. doi: 10.23736/S1973-9087.21.06922-7. Epub 2021 May 27.
PubMed 34042413Paolucci S, Iosa M, Toni D, Barbanti P, Bovi P, Cavallini A, Candeloro E, Mancini A, Mancuso M, Monaco S, Pieroni A, Recchia S, Sessa M, Strambo D, Tinazzi M, Cruccu G, Truini A; Neuropathic pain special interest group of the Italian Neurological Society. Prevalence and Time Course of Post-Stroke Pain: A Multicenter Prospective Hospital-Based Study. Pain Med. 2016 May;17(5):924-30. doi: 10.1093/pm/pnv019. Epub 2015 Dec 14.
PubMed 26814255Scuteri D, Mantovani E, Tamburin S, Sandrini G, Corasaniti MT, Bagetta G, Tonin P. Opioids in Post-stroke Pain: A Systematic Review and Meta-Analysis. Front Pharmacol. 2020 Nov 27;11:587050. doi: 10.3389/fphar.2020.587050. eCollection 2020.
PubMed 33424596Scuteri D, Corasaniti MT, Tonin P, Bagetta G. Eptinezumab for the treatment of migraine. Drugs Today (Barc). 2019 Nov;55(11):695-703. doi: 10.1358/dot.2019.55.11.3069864.
PubMed 31840684Scuteri D, Rombola L, Morrone LA, Bagetta G, Sakurada S, Sakurada T, Tonin P, Corasaniti MT. Neuropharmacology of the Neuropsychiatric Symptoms of Dementia and Role of Pain: Essential Oil of Bergamot as a Novel Therapeutic Approach. Int J Mol Sci. 2019 Jul 6;20(13):3327. doi: 10.3390/ijms20133327.
PubMed 31284573Dolce G, Lucca LF, Pignolo L. Robot-assisted rehabilitation of the paretic upper limb: rationale of the ARAMIS project. J Rehabil Med. 2009 Nov;41(12):1007-101. doi: 10.2340/16501977-0406.
PubMed 19841833Pignolo L, Lucca LF, Basta G, Serra S, Pugliese ME, Sannita WG, Dolce G. A new treatment in the rehabilitation of the paretic upper limb after stroke: the ARAMIS prototype and treatment protocol. Ann Ist Super Sanita. 2016 Apr-Jun;52(2):301-8. doi: 10.4415/ANN_16_02_25.
PubMed 27364408Cramer SC. Functional imaging in stroke recovery. Stroke. 2004 Nov;35(11 Suppl 1):2695-8. doi: 10.1161/01.STR.0000143326.36847.b0. Epub 2004 Sep 23.
PubMed 15388899Lee J, Park E, Lee A, Chang WH, Kim DS, Kim YH. Recovery-related indicators of motor network plasticity according to impairment severity after stroke. Eur J Neurol. 2017 Oct;24(10):1290-1299. doi: 10.1111/ene.13377. Epub 2017 Aug 18.
PubMed 28833921
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROBOCOP (ROBOtic Care of Post-stroke Pain): Study Protocol for a Randomized, Double-blind Trial to Assess Robot-assisted Functional and Motor Recovery and Impact on Post-stroke Pain Development
- ClinicalTrials.gov ID
- NCT05288270
- Acronym / sponsor ID
- Robocop / ISA-ROBOCOP
- Conditions
- Stroke
- Keywords
- Robotic rehabilitation, Pain, stroke recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- S.Anna Rehabilitation InstituteUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 21 Mar 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.
In agreement to the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations that support the importance of physical functioning as core outcome for pain this randomized, double-blind, controlled clinical trial will be the pilot forming the rational basis for the assessment of the efficacy in the use of Robotic rehabilitation system to prevent chronic post stroke pain development. In fact, according to working hypothesis, proprioceptive inputs with high-intensive bilateral movement training of the hemiplegic arm can improve recovery and plasticity, thus preventing chronic post-stroke pain from occurring within the 3-6 months following stroke.
Detailed description
Stroke is one of the most frequent causes of death and disability worldwide. It is accompanied by impaired motor function of the upper extremities in over 69% of patients up to hemiplegia in the following 5 years in 56% of cases. This condition often is characterized by chronic post-stroke pain, difficult to manage and further worsening the patients' quality of life. Post-stroke pain occurs within 3-6 months and aberrant neuroplasticity in the first 3-4 weeks is implicated in its development. Robot-assisted neurorehabilitation using the Automatic Recovery Arm Motility Integrated System (ARAMIS) has proven efficacy in motor function recovery exploiting the movements and the strength of the unaffected arm to drive correct brain re-arrangement. Therefore, the rationale of the ROBOCOP (ROBOtic Care of Post-stroke pain) randomized, double-blind trial for the assessment of the impact of robot-assisted functional and motor recovery on post-stroke pain development is based on the prevention of anomalous plasticity and, hopefully, on the recovery of connectivity in the injured area.
To this aim, a total of 118 patients with hemiplegic arm due to stroke will be enrolled and randomly allocated with 1:1 ratio to ARAMIS or conventional neurorehabilitation group. After a baseline screening at hospital discharge during subacute period, ARAMIS or conventional rehabilitation will be performed for 8 weeks. The primary endpoint will consist in improvement of the Upper Extremity Subscale of the Fugl-Meyer Motor Assessment (FMA-UE), for the body functions of the upper extremity section domain; the Action Research Arm Test (ARAT) scores at 1, 2, 3 and 6 months after stroke. The secondary endpoints include no worsening of pain Visual Analogue Scale (VAS) and improvement of Barthel Index (BI) for activities of daily living and of Frenchay activities index (FAI) for physical activity, as well as improvement of magnetic resonance imaging (MRI) and electroencephalographic (EEG) parameters This is the first clinical trial investigating the efficacy of robot-assisted neurorehabilitation using ARAMIS on brain plasticity and re-organization and on post-stroke pain prevention. This study could remarkably improve the quality of life of stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized, double-blind, single center trial will recruit subacute hemiplegic patients of any age with hemiparesis of the arm after stroke. The trial is designed as prospective, exploratory, interventional study without drug. The study does not request the use of drugs. This study protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist.
| Arm | Type | Receives |
|---|---|---|
| Aramis Group | Experimental | Device: AramisConsecutive patients, admitted to Sant' Anna Institute with diagnosis of stroke after hospital discharge that need motor and cognitive treatment and rehabilitation of neurological diseases. |
| Conventional Group therapy | Active comparator | Other: Conventional therapyConsecutive patients, admitted to Sant' Anna Institute with diagnosis of stroke after hospital discharge that need motor and cognitive treatment and rehabilitation of neurological diseases. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stroke-related hemiplegic arm;
- Hemiplegic subacute patients of any age at hospital discharge after stroke with functional magnetic resonance imaging (fMRI) scan of the area affected.
Key exclusion criteria (4 listed)
- Bilateral impairment;
- Presence of aphasia;
- Presence of cognitive impairment;
- Stroke diagnosis without occurrence of hemiparesis of the upper limb.
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 |
|---|---|---|
| AramisARAMIS is composed of two computer-controlled, symmetric and interacting exoskeletons able to compensate the inadequate strength and accuracy of the paretic arm movements, of which it measures residual motor function, and the effect of gravity during rehabilitation. It acts through motion capture of the movements of the unaffected arm. In so doing, the patient is able to replicate the movements of the healthy arm with the paretic arm in synchronous, asynchronous or active-assisted manner. The robot-assisted neurorehabilitation using ARAMIS consists in 60-min sessions for 8 weeks,structured as follows: * 1 to 4 weeks: asynchronous exercises of repletion by the paretic arm of basic exercises 20 times for a total of 200 repetitions per session; * 5 to 8 weeks: replaced by synchronous exercises (100/session) with active-assisted modality. | Device | Aramis Group |
| Conventional therapyThe control group will receive conventional rehabilitation consisting in passive mobilization of upper and lower limbs, coordination respiratory exercises, cardiovascular conditioning in the setting posture, conditioning in the upright posture, exercises for the trunk control. | Other | Conventional Group therapy |
Primary outcome
Fugl-Meyer Motor Assessment - upper extremity (FMA-UE)
Time frame: up to 6 months after the admission assessment.
Improvement of Fugl-Meyer Motor Assessment (FMA-UE) scores. The score may range from 0 to 115. A higher score indicates better recovery
Action Research Arm Test (ARAT)- Motor recovery scale
Time frame: up to 6 months after the admission assessment.
Improvement of Action Research Arm Test (ARAT) scores. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance
Visual Analogue Scale (VAS) - Pain reduction
Time frame: up to 6 months after the admission assessment.
No worsening of Visual Analogue Scale (VAS). Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in patients who described their pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Barthel Index (BI)
Time frame: up to 6 months after the admission assessment.
Improvement of Barthel Index (BI). Scores on the BI may range from 0-100 points, with a maximum score of 100 points. Score from 80 to 100 indicates that the patient should be able to live indipendently
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- 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.
- 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 19841823Pignolo L. Robotics in neuro-rehabilitation. J Rehabil Med. 2009 Nov;41(12):955-60. doi: 10.2340/16501977-0434.
- Results publication: PubMed 32918105Calabro RS, Filoni S, Billeri L, Balletta T, Cannavo A, Militi A, Milardi D, Pignolo L, Naro A. Robotic Rehabilitation in Spinal Cord Injury: A Pilot Study on End-Effectors and Neurophysiological Outcomes. Ann Biomed Eng. 2021 Feb;49(2):732-745. doi: 10.1007/s10439-020-02611-z. Epub 2020 Sep 11.
- Results publication: PubMed 34065349Calabro RS, Pignolo L, Muller-Eising C, Naro A. Pain Perception in Disorder of Consciousness: A Scoping Review on Current Knowledge, Clinical Applications, and Future Perspective. Brain Sci. 2021 May 20;11(5):665. doi: 10.3390/brainsci11050665.
- Results publication: PubMed 19841834Colizzi L, Lidonnici A, Pignolo L. The ARAMIS project: a concept robot and technical design. J Rehabil Med. 2009 Nov;41(12):1011-101. doi: 10.2340/16501977-0407.
- Results publication: PubMed 34042413Gandolfi M, Vale N, Posteraro F, Morone G, Dell'orco A, Botticelli A, Dimitrova E, Gervasoni E, Goffredo M, Zenzeri J, Antonini A, Daniele C, Benanti P, Boldrini P, Bonaiuti D, Castelli E, Draicchio F, Falabella V, Galeri S, Gimigliano F, Grigioni M, Mazzon S, Molteni F, Petrarca M, Picelli A, Senatore M, Turchetti G, Giansanti D, Mazzoleni S; Italian Consensus Conference on Robotics in Neurorehabilitation (CICERONE). State of the art and challenges for the classification of studies on electromechanical and robotic devices in neurorehabilitation: a scoping review. Eur J Phys Rehabil Med. 2021 Oct;57(5):831-840. doi: 10.23736/S1973-9087.21.06922-7. Epub 2021 May 27.
- Results publication: PubMed 26814255Paolucci S, Iosa M, Toni D, Barbanti P, Bovi P, Cavallini A, Candeloro E, Mancini A, Mancuso M, Monaco S, Pieroni A, Recchia S, Sessa M, Strambo D, Tinazzi M, Cruccu G, Truini A; Neuropathic pain special interest group of the Italian Neurological Society. Prevalence and Time Course of Post-Stroke Pain: A Multicenter Prospective Hospital-Based Study. Pain Med. 2016 May;17(5):924-30. doi: 10.1093/pm/pnv019. Epub 2015 Dec 14.
- Results publication: PubMed 33424596Scuteri D, Mantovani E, Tamburin S, Sandrini G, Corasaniti MT, Bagetta G, Tonin P. Opioids in Post-stroke Pain: A Systematic Review and Meta-Analysis. Front Pharmacol. 2020 Nov 27;11:587050. doi: 10.3389/fphar.2020.587050. eCollection 2020.
- Results publication: PubMed 31840684Scuteri D, Corasaniti MT, Tonin P, Bagetta G. Eptinezumab for the treatment of migraine. Drugs Today (Barc). 2019 Nov;55(11):695-703. doi: 10.1358/dot.2019.55.11.3069864.
- Results publication: PubMed 31284573Scuteri D, Rombola L, Morrone LA, Bagetta G, Sakurada S, Sakurada T, Tonin P, Corasaniti MT. Neuropharmacology of the Neuropsychiatric Symptoms of Dementia and Role of Pain: Essential Oil of Bergamot as a Novel Therapeutic Approach. Int J Mol Sci. 2019 Jul 6;20(13):3327. doi: 10.3390/ijms20133327.
- Results publication: PubMed 19841833Dolce G, Lucca LF, Pignolo L. Robot-assisted rehabilitation of the paretic upper limb: rationale of the ARAMIS project. J Rehabil Med. 2009 Nov;41(12):1007-101. doi: 10.2340/16501977-0406.
- Individual participant dataSharing planned: Yes. De-identified individual partecipant data for all primary and secondary outcome measures will be made 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.
Questions about this trial
What is this clinical trial studying?
A study testing Aramis and Conventional therapy in people with Stroke, run by S.Anna Rehabilitation Institute.
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 2 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: status not confirmed, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Loris Pignolo (+39096223973, l.pignolo@isakr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Motor Assessment - upper extremity (FMA-UE) (time frame: up to 6 months after the admission assessment.). The study lists 4 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 NCT05288270, which also lists 16 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 21 Mar 2022.