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

NCT02274532 | Completed

• 1 other identifier: 13-008649
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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 living tasks than allowed by today's commercially available prosthetic hands, and will exceed established benchmarks for activities of daily living (ADL).

Conditions

Upper Limb Amputation Below Elbow (Injury)

Outcome Measures

Primary Outcomes (1)

• Functional assessments

  DASH score, the Jebsen Taylor Test of Hand Function, and biomechanical measures (including total grip force, load force sharing between the thumb and finger(s), time to peak grip force, and net torque exerted by the subject at object lift onset).

  1 week

Secondary Outcomes (1)

• ADL tests

  1 week

Study Arms (2)

Patient

EXPERIMENTAL

Testing will include self-report questionnaires, assessments of activities of daily living (ADL) by an occupational therapist, and biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks. Motion will be recorded using sensors that are attached to the arm and SoftHand. During each session, videos will be obtained of the subjects performing tasks. The experimental data collections are organized into 5 Sessions, which will take place over the course of 1 week, scheduled by the subject's availability, with the option with patients for a 1-week period of take-home testing and associated pre- and post-assessments.

Device: SoftHand

Control

OTHER

Testing will include self-report questionnaires, assessments of activities of daily living (ADL) by an occupational therapist, and biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks. Motion will be recorded using sensors that are attached to the arm and SoftHand. During each session, videos will be obtained of the subjects performing tasks. The experimental data collections are organized into 4 Sessions, which will take place over the course of 1 week, scheduled by the subject's availability. Control subjects will participate in two sessions, including a pre- and post-training assessments.

Device: SoftHand

Interventions

SoftHand DEVICE

Biomechanical, ADL, and functional testing.

Also known as: SH, SHpro

Control; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Subjects \> 18 years of age.

You may not qualify if:

• 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.
• \) Visual problems that would interfere with our grasp task.
• \) 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
• \) Significant spasticity/rigidity as assessed through range of motion testing that would interfere with our grasp task.
• \) Active psychiatric illness.
• \) Cognitive impairments which would interfere with following study instructions and filling out surveys (at the investigator's discretion).
• \) Use of medications that might affect sensory and/or motor functions.

Sponsors & Collaborators

• Karen L. Andrews, M.D.: lead
• Arizona State University: collaborator
• University of Pisa: collaborator

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Karen L. Andrews, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Physical Medicine & Rehab

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 24, 2014
• Study Start: October 24, 2014
• Primary Completion: May 17, 2016
• Study Completion: May 17, 2016
• Last Updated: January 18, 2018

Record last verified: 2018-01