Powered Exoskeleton for the Treatment of Elbow Spasticity

Phase 2

Completed

• Conditions: Muscle Spasticity; Stroke
• Interventions: Device: Robotic treatment

• Registration Number: NCT02934646
• Lead Sponsor: Auxilium Vitae Volterra

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Upper limb spasticity due to neurological impairment;
2. Cognitive abilities sufficient for understanding instructions;
3. Absence of severe pain assessed as Visual Analogic Score (VAS) < 4 (range 0-10).

Exclusion Criteria

1. Unstable general clinical conditions;
2. Unability to keep sitting posture;
3. Tendon retractions limiting upper limb joints range of motion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subacute stroke patients	Robotic treatment	Elbow passive/active robotic treatment provided by NEUROExos Elbow Module

Primary Outcome Measures

Name	Time	Method
Modified Ashworth Scale	2 weeks	Impairmente level maesure according to ICF

Secondary Outcome Measures

Name	Time	Method
Maximum Extension Torque	2 weeks	Paramenter directly exterted by the device
Zero-Torque Angle	2 weeks	Paramenter directly exterted by the device
Range of Motion	2 weeks	Impairmente level maesure according to ICF