SoftHand Comparison Study

Launched by MAYO CLINIC · Apr 7, 2022

Keywords

ClinConnect Summary

This study will measure improvements in outcomes obtained from laboratory testing of the SHP and i-Limb from baseline to after 8 weeks of daily use. A secondary analysis will incorporate the subjects' existing prosthetic hands. Finally, surveys and usage data collected through the SHP and i-Limb firmware during daily use will complement data the aforementioned outcomes to explore factors that may be related to differences in grasping and manipulation performance.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. the individual can successfully use their prosthesis, list the components used and that their current prosthesis is fitting properly (by performing a tension analysis);
• • 2. 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;
• • 3. the individual is a proficient owner of one or more common myoelectric prosthetic hands, such as the Sensor Hand Speed and Bebionic.
• Exclusion Criteria:
• • 1. individuals who have had transradial amputation for less than 6 months;
• • 2. individuals who have been fit and trained to use a prosthesis but chose not to use one;
• • 3. individuals who use the i-Limb Quantum myoelectric prosthesis;
• • 4. symptomatic brachial plexopathy, cervical radiculopathy or polyneuropathy (observed);
• • 5. orthopedic, joint degeneration (i.e., arthritis, self-reported) affecting the hand or cervical spine that severely limit upper limb function (observed);
• • 6. visual problems that would interfere with the grasping;
• • 7. 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;
• • 8. limited range of motion as assessed through range of motion testing;
• • 9. inability to follow study instructions;
• • 10. use of medications that might affect sensory and/or motor functions.