Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions-A Randomized Controlled Trial Protocol

Abstract

Background: The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy toward functional recovery. However, the current clinical evaluation and treatment of this stiffness (and underlying muscle spasticity) are severely limited by their dependence on subjective evaluation and manual limb mobilization, thus rendering the evaluation imprecise and the treatment insufficiently tailored to the specific pathologies and residual capabilities of individual patients. Methods: To address these needs, the proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol is a randomized controlled trial consisting of a 4-week functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment. The primary outcome measures will be a set of standard clinical scales for upper limb spasticity and motor function assessment, including the Modified Ashworth Scale and Fugl-Meyer Index, to confirm the safety and evaluate the efficacy of robotic rehabilitation in reducing elbow stiffness and improving function. Secondary outcomes will include biomechanical, muscular activity, and motor performance parameters extracted from instrumented assessments using the NEEM along with synchronous EMG recordings. Conclusions: This randomized controlled trial aims to validate an innovative instrumented methodology for clinical spasticity assessment and functional rehabilitation, relying on the precision and accuracy of an elbow exoskeleton combined with EMG recordings and the expertise of a physiotherapist, thus complementing and maximizing the benefits of both practices. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT04484571.

Keywords: exoskeleton; functional rehabilitation; instrumented spasticity assessment; joint stiffness; robotic rehabilitation; stroke; upper limb.

Copyright © 2020 Pilla, Trigili, McKinney, Fanciullacci, Malasoma, Posteraro, Crea and Vitiello.

Figures

Figure 1

Protocol overview—Treatment Group (TG) patients are divided in two exercise levels based on the upper Fugl-Meyer Assessment (FMA) score. Both groups conduct an initial assessment (T0) followed by 4 weeks−20 days treatment therapy, concluding with an additional assessment session (T1).

Figure 2

(A) NEUROExos Elbow Module platform, including: passive regulations to adjust the height and orientation for each patient; actuation unit; wheeled platform to move the device in the 3-D workspace; graphical user interface (GUI) control via a laptop. (B) Detail of the elbow module.

Figure 3

Example of an experimental setup. The patient, donning the exoskeleton and with electrodes positioned on the impaired arm, follows the reference angle (orange) depicted on the screen while keeping the actual joint angle (blue) as close as possible.

Figure 4

(A) Each exercise block consists of ramp/sigmoidal movements from the maximum ROM angle to the minimum, followed by a Static Hold time interval where the patient is asked to maintain the given position. Movement is then inverted and repeated with the same modality until the number of performed cycles nc equals the desired number of movements N. (B) Workflow for the robotic assessment and (C) treatment procedures.