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Completed

NCT Number: NCT02934646

Powered Exoskeleton for the Treatment of Elbow Spasticity

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic treatment

Device

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

Primary outcomes

  1. Modified Ashworth Scale

    Time frame: 2 weeks

    Impairmente level maesure according to ICF

Secondary outcomes

  1. Range of Motion

    Time frame: 2 weeks

    Impairmente level maesure according to ICF

  2. Maximum Extension Torque

    Time frame: 2 weeks

    Paramenter directly exterted by the device

  3. Zero-Torque Angle

    Time frame: 2 weeks

    Paramenter directly exterted by the device

Sponsors and collaborators

Lead sponsor

Auxilium Vitae Volterra

Other

Collaborators

  • Azienda USL Toscana Nord Ovest
  • Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2016
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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