Status:
COMPLETED
Assessing Force Feedback With the SoftHand Pro
Lead Sponsor:
Kristin Zhao, PhD
Collaborating Sponsors:
Arizona State University
University of Pisa
Conditions:
Amputation, Traumatic
Limb Defect
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The trial is designed to test the effectiveness of a force-feedback cuff in combination with a myoelectric prosthesis in conveying information on grasp strength to the user, as well as the user's pref...
Detailed Description
The human sensorimotor control system uses both feedforward planning and sensory feedback information, in order to actuate the musculoskeletal system and interact with the external environment, e.g. w...
Eligibility Criteria
Inclusion
- age \> 18 years.
- no prior experience with the CUFF device.
- history of elbow disarticulation, transradial, or transhumeral limb loss (non-control subjects only).
Exclusion
- amputation for less than 6 months
- clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy
- orthopedic, joint degeneration (i.e., arthritis, verified by x-ray) affecting the hand or cervical spine that severely limit upper limb function
- visual problems that would interfere with the grasp task
- co-existing central nervous system disease with symptoms that limit upper extremity function (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) revealed in medical history
- significant rigidity as assessed through range of motion testing
- active psychiatric illness
- significant cognitive impairments (a score \< 24 on the Mini-Mental State Examination)
- use of medications that might affect sensory and/or motor functions
- inability to effectively control myoelectrics for study purposes (control subjects only)
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2019
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03412656
Start Date
October 17 2017
End Date
June 14 2019
Last Update
November 20 2020
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905