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Active Not RecruitingNANCT05328934

SoftHand Comparison Study

A trial to compare the performance of the SoftHand Pro (SHP) and Ossur i-Limb in people with transradial limb loss over an 8-week period.

Lead sponsor: Mayo Clinic•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Mayo Clinic

Collaborators

Arizona State University
Hanger Clinic: Prosthetics & Orthotics

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.

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 14, 2025Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

PhaseNA

Enrollment36

Start dateApr 2022

Last updatedOct 14, 2025

Condition

Upper Extremity Injury Upper Extremity Deformities, Congenital Amputation, Traumatic Amputation, Congenital

Locations shown

Arizona State University

Tempe, Arizona

Mayo Clinic

Rochester, Minnesota

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2025Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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