Multimodal Instrumented Assessment of Post-stroke Elbow

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spasticity, Muscle, Stroke, Upper Limb

Intervention / Treatment
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* Device: Neuroexsos elbow module


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic treatment<br>Patients receive 4 weeks of elbow rehabilitation treatment provided by the NEEM robotic elbow exoskeleton | Device: Neuroexsos elbow module<br>* The treatment group will be further divided into two levels (sub-groups), based on pathological severity: Level 1 corresponds to an FM score equal or below 28, and Level 2 with FM greater than 28. The two sub-groups will receive different combinations of robotically assisted passive mobilization (PM) and active mobilization (AM) treatment modalities, according to their differing clinical needs<br>|
| Active Comparator: Conventional treatment<br>Patients receive 4 weeks of elbow conventional rehabilitation treatment matched in time | Device: Neuroexsos elbow module<br>* The treatment group will be further divided into two levels (sub-groups), based on pathological severity: Level 1 corresponds to an FM score equal or below 28, and Level 2 with FM greater than 28. The two sub-groups will receive different combinations of robotically assisted passive mobilization (PM) and active mobilization (AM) treatment modalities, according to their differing clinical needs<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Maximum Extension Torque (MET) | It corresponds to the maximum torque value recorded during a static hold phase at the maximum reached extension angle | Before and within 1 week after 4 weeks of treatment | 
| Change in Zero Torque Angle (ZTA) | 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 | Before and within 1 week after 4 weeks of treatment | 
| Change in Joint Impedance (JIMP) | 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). | Before and within 1 week after 4 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper extremities, EMG, Robotics