Powered Exoskeleton for the Treatment of Elbow Spasticity

NCT ID: NCT02934646

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subacute stroke patients

Elbow passive/active robotic treatment provided by NEUROExos Elbow Module

Group Type: EXPERIMENTAL

Robotic treatment

Intervention Type: DEVICE

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

Interventions

Robotic treatment

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Toscana Nord Ovest

OTHER

Sponsor Role: collaborator

Scuola Superiore Sant'Anna di Pisa

OTHER

Sponsor Role: collaborator

Auxilium Vitae Volterra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RN20161

Identifier Type: -

Identifier Source: org_study_id