SoftHand Comparison Study
Completed · Not applicable
Conditions studied: Upper Extremity Injury, Upper Extremity Deformities, Congenital, Amputation, Traumatic, Amputation, Congenital
In brief
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.
Key facts
- Study ID
- NCT05328934
- Run by
- Mayo Clinic
- People needed
- 36
- Starts
- 2022-04-28
- Expected to finish
- 2026-04-10
- Last updated by the study team
- 2026-06-12
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Arizona State University — Tempe, Arizona, United States
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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