Clincosm LogoSign in Get a demo

CUFF: Assessing Force Feedback With the SoftHand Pro

Sponsor
Kristin Zhao, PhD (Other)
Overall Status
Completed
CT.gov ID
NCT03412656
Collaborator
Arizona State University (Other), University of Pisa (Other)
27
Enrollment
1
Location
2
Arms
19.9
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: SoftHand Pro with CUFF force feedback device
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel 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 :
Oct 17, 2017
Actual Primary Completion Date :
Jun 14, 2019
Actual Study Completion Date :
Jun 14, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient

Testing will include assessments of activities of daily living (ADLs) by a physical therapist, biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks, and surveys assessing user preference regarding the force feedback feature, all while using the SoftHand Pro myoelectric lower arm prosthetic and the CUFF force feedback devices in tandem, utilizing the subjects' own prosthetic sockets. Grip force will be recorded using sensors attached to the CUFF device. During each session, videos will be obtained of the subjects performing tasks for kinematics analysis. The experimental sessions are organized into one to two sessions, comprising up to 16 hours, as determined by subject availability.

Device: SoftHand Pro with CUFF force feedback device
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.
Other Names:
  • SoftHand
  • SoftHand Pro
  • CUFF
  • SHpro

    		•
    Other: Control

    Testing will include assessments of activities of daily living (ADLs) by a physical therapist, biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks, and surveys assessing user preference regarding the force feedback feature, all while using the SoftHand Pro myoelectric lower arm prosthetic and the CUFF force feedback devices in tandem, utilizing an adapter simulating a prosthetic socket. Grip force will be recorded using sensors attached to the CUFF device. During each session, videos will be obtained of the subjects performing tasks for kinematics analysis. The experimental sessions are organized into one to two sessions, comprising up to 16 hours, as determined by subject availability.

    Device: SoftHand Pro with CUFF force feedback device
    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.
    Other Names:
  • SoftHand
  • SoftHand Pro
  • CUFF
  • SHpro

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Conveyance of force feedback [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 [1 year]

      Assessments will determine any improvement of device embodiment from the addition of grip force feedback to the Soft Hand Pro.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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 elbow disarticulation, transradial, or transhumeral limb loss (non-control subjects only).

    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

    10. inability to effectively control myoelectrics for study purposes (control subjects only)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Kristin Zhao, PhD
    • Arizona State University
    • University of Pisa

    Investigators

    • Principal Investigator: Kristin D. Zhao, Ph.D., Mayo Clinic
    • Principal Investigator: Karen L. Andrews, M.D., Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Kristin Zhao, PhD, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03412656
    Other Study ID Numbers:
    • 17-005611
    First Posted:
    Jan 26, 2018
    Last Update Posted:
    Nov 20, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Kristin Zhao, PhD, Principal Investigator, Mayo Clinic
    CUFF
    Soft Hand Pro
    SHP
    SH Pro
    SoftHand
    Additional relevant MeSH terms:
    Amputation, Traumatic

    Study Results

    No Results Posted as of Nov 20, 2020