Multimodal Instrumented Assessment of Post-stroke Elbow

Not Applicable

• Conditions: Spasticity, Muscle; Stroke; Upper Limb
• Interventions: Device: Neuroexsos elbow module

• Registration Number: NCT04484571
• Lead Sponsor: Azienda USL Toscana Nord Ovest

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-07-06
• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-23
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-22
• Last Update Posted: 2023-07-25
• Primary Completion: 2024-05-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic treatment	Neuroexsos elbow module	Patients receive 4 weeks of elbow rehabilitation treatment provided by the NEEM robotic elbow exoskeleton
Conventional treatment	Neuroexsos elbow module	Patients receive 4 weeks of elbow conventional rehabilitation treatment matched in time

Primary Outcome Measures

Name	Time	Method
Change in the score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better	before and within 1 week after 4 weeks of treatment	It is a clinical scale used for the assessment of motor function in stroke patients
Change in the score of Modified Ashworth Scale (MAS 0-5 scoring 1+ as 2 for statistical analysis) higher score means worse	Before and within 1 week after 4 weeks of treatment	It is a clinical scale for spasticity assessment

Secondary Outcome Measures

Name	Time	Method
Change in Maximum Extension Torque (MET)	Before and within 1 week after 4 weeks of treatment	It corresponds to the maximum torque value recorded during a static hold phase at the maximum reached extension angle
Change in Zero Torque Angle (ZTA)	Before and within 1 week after 4 weeks of treatment	It is the angular value corresponding to null torque exerted by the robot; in this configuration, flexor and extensor torques are equal and opposite and the system is ideally not applying any force to hold the elbow in position, which has reached its equilibrium point
Change in Joint Impedance (JIMP)	Before and within 1 week after 4 weeks of treatment	A measure of the limb resistance to muscle elongation, extracted as the ratio between joint torque and joint angular position for constant, slow-speed movements, the main contribution to the joint impedance can be identified in the joint stiffness (i.e. rigidity).

Trial Locations

Locations (1)

Ospedale Versilia; 🇮🇹 Camaiore, Lucca, Italy