Assessing Force Feedback With the SoftHand Pro (CUFF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03412656
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : March 22, 2018
Arizona State University
University of Pisa
Information provided by (Responsible Party):
Kristin Zhao, PhD, Mayo Clinic

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 preference regarding the feature.

Condition or disease Intervention/treatment Phase
Amputation, Traumatic Limb Defect Device: SHPro with CUFF Not Applicable

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. when modulating grip force for various object properties. As a result, lack of sensory input, as in the case of motor impairments or amputations, can dramatically affect activities of daily living (ADLs). The contribution of the proposed research will be to test the effectiveness of a novel, non-invasive prosthetic technology in delivering sensory information. The investigators' approach is "modality matching," in that it produces a sensation in the user similar to the type of information to be transmitted. Specifically, the approach will combine the Soft Hand Pro (SHP), an anthropomorphic, myoelectrically controlled prosthetic hand, with an upper limb force feedback device (CUFF) to provide patients with transradial amputations with grasp force (pressure) information.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Assessing the Effectiveness of Upper-limb Force Feedback With the SoftHand Pro Myoelectric Prosthesis in Persons With Transradial Limb Loss
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Patient Device: SHPro with CUFF
Participants will complete various movement and activity of daily living (ADL) assessments to test the effectiveness of the CUFF device in combination with the Soft Hand Pro (SHP) in conveying haptic force feedback to patients with transradial limb loss, and to assess the extent to which the grip force feedback improves the embodiment of the prosthetic device.

Primary Outcome Measures :
  1. Conveyance of force feedback [ Time Frame: 1 year ]
    Assessments will measure the extent to which the CUFF device conveys haptic force feedback, when used in combination with the Soft Hand Pro.

  2. Improvement to device embodiment through addition of grip force feedback [ Time Frame: 1 year ]
    Assessments will determine any improvement of device embodiment from the addition of grip force feedback to the Soft Hand Pro.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. age > 18 years.
  2. no prior experience with the CUFF device.
  3. history of transradial limb loss.

Exclusion Criteria:

  1. amputation for less than 6 months
  2. clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy
  3. orthopedic, joint degeneration (i.e., arthritis, verified by x-ray) affecting the hand or cervical spine that severely limit upper limb function
  4. visual problems that would interfere with the grasp task
  5. 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
  6. significant rigidity as assessed through range of motion testing
  7. active psychiatric illness
  8. significant cognitive impairments (a score < 24 on the Mini-Mental State Examination)
  9. use of medications that might affect sensory and/or motor functions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03412656

Contact: Tyson L. Scrabeck (507)538-1016

United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tyson L. Scrabeck    507-538-1016   
Sponsors and Collaborators
Kristin Zhao, PhD
Arizona State University
University of Pisa
Principal Investigator: Kristin D. Zhao, Ph.D. Mayo Clinic
Principal Investigator: Karen L. Andrews, M.D. Mayo Clinic

Responsible Party: Kristin Zhao, PhD, Principal Investigator, Mayo Clinic Identifier: NCT03412656     History of Changes
Other Study ID Numbers: 17-005611
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Kristin Zhao, PhD, Mayo Clinic:
Soft Hand Pro
SH Pro

Additional relevant MeSH terms:
Amputation, Traumatic
Wounds and Injuries