Status:

COMPLETED

Myoelectric SoftHand Pro to Improve Prosthetic Function for People With Below-elbow Amputations: A Feasibility Study

Lead Sponsor:

Karen L. Andrews, M.D.

Collaborating Sponsors:

Arizona State University

University of Pisa

Conditions:

Upper Limb Amputation Below Elbow (Injury)

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

A study to investigate the hypothesis that a Pisa/IIT Robotic SoftHand Pro converted to a prosthetic terminal device will enhance the performance of people with limb loss in a wider range of daily liv...

Detailed Description

Preliminary data suggest that the SoftHand Pro (SHpro) is extremely versatile and can be used to grasp and manipulate common objects. We will perform extensive testing of the myoelectric SHpro by aski...

Eligibility Criteria

Inclusion

  • 1\) Subjects \> 18 years of age.

Exclusion

  • Patients with an amputation for less than 6 months.
  • Patients who have been fit and trained to use a prothesis but chose not to do so.
  • Clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy and persistent weakness.
  • 5\) Visual problems that would interfere with our grasp task.
  • 6\) Co-existing central nervous system disease (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) that would interfere with our grasp task
  • 7\) Significant spasticity/rigidity as assessed through range of motion testing that would interfere with our grasp task.
  • 8\) Active psychiatric illness.
  • 9\) Cognitive impairments which would interfere with following study instructions and filling out surveys (at the investigator's discretion).
  • 10\) Use of medications that might affect sensory and/or motor functions.

Key Trial Info

Start Date :

October 24 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 17 2016

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT02274532

Start Date

October 24 2014

End Date

May 17 2016

Last Update

January 18 2018

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