A Study to Evaluate SoftHand Pro for Daily Activities of Transradial Amputees

Overview

About this study

The purpose of this study is to compare the performance of the SoftHand Pro (SHP) and Ossur i-Limb in grasping and manipulations tasks, and to determine how grasping and manipulation performance improves over time with each device.  Data will also be obtained regarding usage patterns and user satisfaction with each device.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • The individual can successfully use their prosthesis, list the components used and that their current prosthesis is fitting properly (by performing a tension analysis);
  • The individual had unilateral transradial limb loss more than 6 months before the clinical evaluation because, to use a myoelectric prosthesis, the residual limb volume needs to be stable;
  • The individual is a proficient owner of one or more common myoelectric prosthetic hands, such as the Sensor Hand Speed and Bebionic.

Exclusion Criteria: 

  • Individuals who have had transradial amputation for less than 6 months.
  • Individuals who have been fit and trained to use a prosthesis but chose not to use one.
  • Individuals who use the i-Limb Quantum myoelectric prosthesis.
  • Brachial plexopathy, cervical radiculopathy or polyneuropathy that severely limit upper limb function (observed).
  • Orthopedic, joint degeneration (i.e., arthritis, self-reported) affecting the hand or cervical spine that severely limit upper limb function (observed).
  • History or concurrently observed age-related neurologic, musculoskeletal, or orthopedic degeneration which would affect study outcomes.
  • Visual problems that would interfere with the grasping.
  • 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.
  • Limited range of motion as assessed through range of motion testing.
  • Inability to follow study instructions.
  • Use of medications that might affect sensory and/or motor functions.      

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/14/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kristin Zhao, Ph.D., M.S.

Open for enrollment

Contact information:

Tyson Scrabeck CCRP

(507) 538-1016

Scrabeck.Tyson@mayo.edu

More information

Publications

Publications are currently not available