Powered Exoskeleton for the Treatment of Elbow Spasticity

NCT02934646 | Completed Phase 2

• 1 other identifier: RN20161
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Muscle Spasticity; Stroke

Keywords

Robotics; Upper Extremity

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth Scale

  Impairmente level maesure according to ICF

  2 weeks

Secondary Outcomes (3)

• Range of Motion

  2 weeks

• Maximum Extension Torque

  2 weeks

• Zero-Torque Angle

  2 weeks

Study Arms (1)

Subacute stroke patients

EXPERIMENTAL

Elbow passive/active robotic treatment provided by NEUROExos Elbow Module

Device: Robotic treatment

Interventions

Robotic treatment DEVICE

Passive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device

Subacute stroke patients

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Auxilium Vitae Volterra: lead
• Azienda USL Toscana Nord Ovest: collaborator
• Scuola Superiore Sant'Anna di Pisa: collaborator

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 17, 2016
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share