ROBOtic Care of Post-stroke Pain.

Stroke Clinical Trial

— Robocop  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05288270
• Other study ID #: ISA-ROBOCOP
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: March 2022
• Source: S.Anna Rehabilitation Institute
• Contact: Loris Pignolo
• Phone: +39096223973
• Email: l.pignolo[@]isakr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Aramis
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.

Other:
• Conventional therapy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
S.Anna Rehabilitation Institute

References & Publications (16)

Calabrò RS, Filoni S, Billeri L, Balletta T, Cannavò 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: 10.1 — View Citation

Calabrò RS, Pignolo L, Müller-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). pii: 665. doi: 10.3390/brainsci11050665. Revi — View Citation

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. — View Citation

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. — View Citation

Cramer SC. Functional imaging in stroke recovery. Stroke. 2004 Nov;35(11 Suppl 1):2695-8. Epub 2004 Sep 23. — View Citation

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. — View Citation

Gandolfi M, Valè 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, Mazz — View Citation

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. — View Citation

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. — View Citation

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: 10.441 — View Citation

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.2019.10468 — View Citation

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

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. Review. — View Citation

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. Review. — View Citation

Scuteri D, Rombolà 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 Ju — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.