Powered Exoskeleton for the Treatment of Elbow Spasticity

Study Overview
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Brief Summary
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This is a phase-II clinical study to assess whether intense passive mobilization of the elbow during the early stage is effective in preventing spasticity from occurring at a later stage. A group of subacute stroke patients was treated with the device named NEUROExos Elbow Module (NEEM) on a daily basis, in addition to traditional physical therapy. The outcome was assessed in terms of (i) system safety, (ii) system usability and (iii) treatment efficacy. Investigators expected that intense therapy performed in the sub-acute phase following the stroke would be effective in preventing elbow spasticity from occurring at a later stage (i.e. 3-4 months after the stroke), the latter being quantified by means of the Modified Ashworth Scale (MAS). Similarly to other phase-II studies in the field of post-stroke rehabilitation, the present study will include only one group of patients. As a secondary objective, similarly to other studies with robot-assisted therapy, investigators wiil test the ability of this system to be used for assessing rehabilitation outcome. Investigators will introduce novel evaluation metrics based on the kinematics and kinetics variables recorded by the NEEM and compared them with MAS values.

Official Title
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Clinical Validation of a Powered Exoskeleton for the Treatment of Elbow Spasticity: Phase II Study

Conditions
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Muscle Spasticity, Stroke

Intervention / Treatment
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* Device: Robotic treatment


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; Unability 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: 79 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subacute stroke patients<br>Elbow passive/active robotic treatment provided by NEUROExos Elbow Module | Device: Robotic treatment<br>* Passive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale | Impairmente level maesure according to ICF | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Impairmente level maesure according to ICF | 2 weeks | 
| Maximum Extension Torque | Paramenter directly exterted by the device | 2 weeks | 
| Zero-Torque Angle | Paramenter directly exterted by the device | 2 weeks | 

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