Multimodal Instrumented Assessment of Post-stroke Elbow

  • STATUS
    Recruiting
  • End date
    Jul 30, 2022
  • participants needed
    60
  • sponsor
    Azienda USL Toscana Nord Ovest
Updated on 25 January 2021
stroke
rehabilitation therapy
hemiparesis
spasticity
passive mobilization
chronic stroke

Summary

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.

Details
Condition Cerebrovascular accident, Upper Extremity, Spasticity, Stroke, cerebrovascular accidents, strokes, cerebral
Treatment Neuroexsos elbow module
Clinical Study IdentifierNCT04484571
SponsorAzienda USL Toscana Nord Ovest
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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