ROBOCOP (ROBOtic Care of Poststroke Pain): Study Protocol for a Randomized Trial to Assess Robot-Assisted Functional and Motor Recovery and Impact on Poststroke Pain Development.

Damiana Scuteri,Paolo Tonin,Pierluigi Nicotera,Loris Pignolo,Giacinto Bagetta

doi:10.3389/fneur.2022.813282

Abstract

BackgroundStroke is one of the most frequent causes of death and disability worldwide. It is accompanied by the 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 poststroke pain, difficult to manage, further worsening quality of life. Poststroke pain occurs within 3–6 months. 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. The rationale of the ROBOCOP (ROBOtic Care of Poststroke pain) randomized trial is the assessment of the impact of robot-assisted functional and motor recovery on the prevention of poststroke pain.MethodsA total of 118 patients with hemiplegic arms due to stroke will be enrolled and randomly allocated with a 1:1 ratio to ARAMIS or conventional neurorehabilitation group. After a baseline screening at hospital discharge, ARAMIS or conventional rehabilitation will be performed for 8 weeks. The primary endpoint is the prevention of the development of poststroke pain and the secondary endpoints are prevention of spasticity and efficacy in clinical motor rehabilitation. The primary outcome measures consist in the visual analog scale and the doleur neuropatique 4 and the secondary outcome measures include: the Modified Ashworth Scale, the Resistance to Passive movement Scale; the Upper Extremity Subscale of the Fugl–Meyer Motor Assessment; the Action Research Arm Test; the Barthel Index for activities of daily living; and the magnetic resonance imaging (MRI) recovery-related parameters. After baseline, both primary and secondary outcome measures will be performed in the following time points: 1 month after stroke (t1, half of the rehabilitation); 2 months after stroke (t2, after rehabilitation); and 3 months (t3) and 6 months (t4) after stroke, critical for poststroke pain development.DiscussionThis is the first clinical trial investigating the efficacy of robot-assisted neurorehabilitation using ARAMIS on poststroke pain prevention. This study could remarkably improve the quality of life of stroke survivors.

Highlights

IntroductionBackground and RationaleStroke represents one of the most serious causes of death and disability-adjusted life-years lost [1] destined to keep increasing due to global aging
The latter include pain caused by different pathophysiology in which nociceptive and neuropathic features can coexist ranging from pain secondary to spasticity, shoulder pain, complex regional pain syndrome (CRPS), and headache, in 1 out of 10 stroke sufferers, that is, migraine-like in 31.3% cases [7], to central poststroke pain [8]
In agreement with the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations that support the importance of physical functioning as the core outcome for pain [19] this randomized controlled clinical trial (Calabria Region Ethics Committee protocol N.244 of 09/21/2021) will be the pilot forming the rational basis for the assessment of the efficacy in the use of Automatic Recovery Arm Motility Integrated System (ARAMIS) to prevent chronic poststroke pain development

Summary

Introduction

Background and RationaleStroke represents one of the most serious causes of death and disability-adjusted life-years lost [1] destined to keep increasing due to global aging. Stroke survivors do not even benefit from clinical trials on the novel preventative treatment of migraine, e.g., the anticalcitonin generelated peptide monoclonal antibody eptinezumab that can provide rapid and longer-lasting action [12] This is often due to the lack of use of pain scales for an objective pain assessment validated in specific populations, e.g., patients affected by stroke, and this problem becomes even more worrying for patients with aphasia and noncommunicative and in the pandemic emergency [13–16]. Stroke is one of the most frequent causes of death and disability worldwide It is accompanied by the impaired motor function of the upper extremities in over 69% of patients up to hemiplegia in the following 5 years in 56% of cases. The rationale of the ROBOCOP (ROBOtic Care of Poststroke pain) randomized trial is the assessment of the impact of robot-assisted functional and motor recovery on the prevention of poststroke pain

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