Powered Exoskeleton for the Treatment of Elbow Spasticity

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Muscle Spasticity
• Intervention / Treatment: Device: Robotic treatment

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subacute stroke patients; Elbow passive/active robotic treatment provided by NEUROExos Elbow Module	Device: Robotic treatment; Passive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Auxilium Vitae Volterra
• Collaborators: Azienda USL Toscana Nord Ovest; Scuola Superiore Sant'Anna di Pisa

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Robotics; Upper Extremity
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: RN20161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No