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Multimodal Instrumented Assessment of Post-stroke Elbow

Multimodal Instrumented Assessment of Post-stroke Elbow

Recruiting
18-80 years
All
Phase 2/3

Overview

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.

Description

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 towards 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. 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 stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol provide a functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.

Eligibility

Inclusion Criteria:

  • Upper limb spasticity due to neurological impairment;
  • Cognitive abilities sufficient for understanding instructions;
  • Absence of severe pain assessed as Visual Analogic Score (VAS) < 4 (range 0-10).

Exclusion Criteria:

  • Unstable general clinical conditions;
  • Inability to keep sitting posture;
  • Tendon retractions limiting upper limb joints range of motion.

Study details
    Cerebrovascular accident
    Upper Extremity
    Spasticity

NCT04484571

Azienda USL Toscana Nord Ovest

16 February 2024

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