Status:
ACTIVE_NOT_RECRUITING
SoftHand Comparison Study
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Arizona State University
Hanger Clinic: Prosthetics & Orthotics
Conditions:
Upper Extremity Injury
Upper Extremity Deformities, Congenital
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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'...
Eligibility Criteria
Inclusion
- 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
- 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;
- symptomatic brachial plexopathy, cervical radiculopathy or polyneuropathy (observed);
- orthopedic, joint degeneration (i.e., arthritis, self-reported) affecting the hand or cervical spine that severely limit upper limb function (observed);
- 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.
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05328934
Start Date
April 28 2022
End Date
May 1 2026
Last Update
October 14 2025
Active Locations (2)
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1
Arizona State University
Tempe, Arizona, United States, 85281-9709
2
Mayo Clinic
Rochester, Minnesota, United States, 55905