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Completed

NCT Number: NCT03412656

Assessing Force Feedback With the SoftHand Pro

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years.
  • no prior experience with the CUFF device.
  • history of elbow disarticulation, transradial, or transhumeral limb loss (non-control subjects only).

Exclusion criteria

  • 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)

Treatment and study plan

SoftHand Pro with CUFF force feedback device

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kristin Zhao, PhD

Other

Collaborators

  • Arizona State University
  • University of Pisa

Registry information

Official study title

Assessing the Effectiveness of Upper-limb Force Feedback With the SoftHand Pro Myoelectric Prosthesis in Persons With Transradial Limb Loss

Acronym: CUFF

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2018
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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