ROBOtic Care of Post-stroke Pain.

NCT05288270 | Unknown DMC

• 1 other identifier: ISA-ROBOCOP
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Stroke

Keywords

Robotic rehabilitation; Pain; stroke recovery

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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).

  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

  up to 6 months after the admission assessment.

Study Arms (2)

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.

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.

Other: Conventional therapy

Interventions

Aramis DEVICE

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.

Aramis Group

Conventional therapy OTHER

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.

Conventional Group therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Bilateral impairment;
• Presence of aphasia;
• Presence of cognitive impairment;
• Stroke diagnosis without occurrence of hemiparesis of the upper limb.

Sponsors & Collaborators

• S.Anna Rehabilitation Institute: lead

Related Publications (16)

• 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.

  PMID: 30065642 RESULT

• Pignolo 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.

  PMID: 31737755 RESULT

• Pignolo L. Robotics in neuro-rehabilitation. J Rehabil Med. 2009 Nov;41(12):955-60. doi: 10.2340/16501977-0434.

  PMID: 19841823 RESULT

• Calabro 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.

  PMID: 32918105 RESULT

• Calabro 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.

  PMID: 34065349 RESULT

• Colizzi 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.

  PMID: 19841834 RESULT

• Gandolfi 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.

  PMID: 34042413 RESULT

• Paolucci 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.

  PMID: 26814255 RESULT

• Scuteri 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.

  PMID: 33424596 RESULT

• Scuteri 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.

  PMID: 31840684 RESULT

• Scuteri 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.

  PMID: 31284573 RESULT

• Dolce 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.

  PMID: 19841833 RESULT

• Pignolo 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.

  PMID: 27364408 RESULT

• Cramer 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.

  PMID: 15388899 RESULT

• Lee 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.

  PMID: 28833921 RESULT

• Ustinova KI, Goussev VM, Balasubramaniam R, Leven MF. Disruption of coordination between arm, trunk, and center of pressure displacement in patients with hemiparesis. Motor Control. 2004 Apr;8(2):139-59. doi: 10.1123/mcj.8.2.139.

  PMID: 15118199 RESULT

MeSH Terms

Conditions

Stroke; Pain

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Loris Pignolo

CONTACT

+39096223973; l.pignolo@isakr.it

Loris Pignolo

CONTACT

+39096227579; l.pignolo@isakr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: March 21, 2022
• Study Start: April 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2023
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 year after the end of the study
• Access Criteria: Data access request will be reviewed by an internal audit committee in conjunction with a panel of university experts