SoftHand Comparison Study

Launched by MAYO CLINIC · Apr 7, 2022

Keywords

ClinConnect Summary

This study compares two upper-limb prosthetic hands—SoftHand Pro (SHP) and Ossur i-Limb—in people with a single forearm amputation (transradial). It uses a randomized crossover design, meaning each participant will try both devices in random order for about eight weeks each. Researchers will look at how well the hands help with daily tasks and overall function, using a primary measure of upper-extremity function (AM-ULA) after eight weeks. They’ll also use many secondary tests and surveys to assess dexterity, grip, daily activities, satisfaction, and quality of life, plus data from the devices’ own usage logs.

Who can participate: adults aged 18 to about 99 with a unilateral transradial amputation that happened more than six months ago and who currently use a myoelectric prosthesis that fits well. Candidates should own one or more common myoelectric hands. Exclusions include recent transradial amputation (within six months), not using a prosthesis, certain nerve/spine conditions, significant hand joint problems or visual or brain conditions, and other factors that could affect participation. The study is being conducted at Arizona State University in Tempe and Mayo Clinic in Rochester, with an estimated 36 participants. The trial is ongoing and devices under study include SoftHand Pro (an unapproved device for this use) and the Ossur i-Limb, with testing over an eight-week period for each device and crossover between them.

Gender

ALL

Eligibility criteria

• 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.