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SoftHand Comparison Study | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

SoftHand Comparison Study

Toward Use of the Synergy-based SoftHand Pro for Activities of Daily Living by Persons With Transradial Limb Loss: A Multi-site Clinical Trial

NCT05328934•Mayo Clinic

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Arizona State University

Tempe, Arizona, United States

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

April 28, 2022

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

October 14, 2025

Enrollment

ESTIMATED participants

Conditions

Upper Extremity InjuryUpper Extremity Deformities, CongenitalAmputation, TraumaticAmputation, Congenital

Interventions

SoftHand Pro

DEVICE

Ossur i-Limb

DEVICE

The Influence of 3D Printed Prostheses on Neural Activation Patterns

NCT04110730

Amniotic Band SyndromeUpper Extremity Deformities, Congenital

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RECRUITINGNA

Early Discovery of Ischemia After Replantation Surgery of the Extremities

NCT05297266

IschemiaBlood Circulation Disorder+3 more

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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: March 29, 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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SoftHand Comparison Study

Inclusion Criteria

Exclusion Criteria

The Influence of 3D Printed Prostheses on Neural Activation Patterns

Early Discovery of Ischemia After Replantation Surgery of the Extremities

Multi-axis Assessment of Injured Workers

Comparison Between Digital Nerve Microanastomosis and Traction Neurectomy in Post-Digital Amputation Pain

Neuromusculoskeletal Interface for Bionic Arms

Low Cost Socket for Lower Limb Amputees