Multimodal Instrumented Assessment of Post-stroke Elbow

Azienda USL Toscana Nord Ovest

Status: Invitation-only

Conditions: Spasticity, Muscle; Stroke; Upper Limb

Treatments: Device: Neuroexsos elbow module

Study type: Interventional

Funder types: Other

Identifiers

NCT04484571

NEEM20160118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Robotic treatment

Experimental group

Description:

Patients receive 4 weeks of elbow rehabilitation treatment provided by the NEEM robotic elbow exoskeleton

Treatment:

Device: Neuroexsos elbow module

Conventional treatment

Active Comparator group

Description:

Patients receive 4 weeks of elbow conventional rehabilitation treatment matched in time

Treatment:

Device: Neuroexsos elbow module