Active — Not RecruitingNot Applicable

SoftHand Comparison Study

United States36 participantsStarted 2022-04-28

Plain-language 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.

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;

Upper Extremity Functional Ability [1]

Timeframe: 8 Weeks

NCT IDNCT05328934

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;