SoftHand Comparison Study (NCT05328934) | Clinical Trial Compass
CompletedNot 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;