Athletic shoe tech could revolutionize prosthetic arm sockets
NCT ID NCT05990062
First seen Jul 17, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This study tests a new type of prosthetic socket for people with below-elbow amputations. The K-Socket-Harness system uses a flexible, breathable design inspired by athletic shoes, aiming to be more comfortable and secure than standard hard sockets. Researchers will fit 25 veterans with the new socket and measure how well it holds up during tasks like rowing, as well as how easy it is to use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- K-Socket-Harness (KSH) system, a hybrid polymer and textile-based prosthetic socket and harness
- What this could lead to
- If successful, this could lead to a more comfortable and functional prosthetic socket for people with below-elbow amputations, improving daily life and activity levels.
- What could go wrong
- This is an early-stage study with only 25 participants, so results may not apply to all amputees. The new socket might not be as durable or effective as standard options.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Unilateral transradial arm amputation * Possession of a functioning and wearable previously fit prosthetic arm of any type * Residual limb length of at least 4 inches from the lateral epicondyle to the distal tip * Residual limb length less than or equal to that allowing a clearance of 1.5 inches from a fitted wrist * Must have at least 5-years of prosthetic use experience (For Phase 1 \& 2) * Must have at least 1-year of prosthetic use experience (For Phase 3 only) Exclusion Criteria: * Current open sores or incisions, Heterotopic ossification (HO), traumatic neuromas, or any other condition preventing the wearing of a prosthetic socket * Residual limb length less than 4 inches * Residual limb length greater than that allowing 1.5 inches clearance from a fitted wrist. The investigators will make every effort to recruit Veterans. If its found that it is not possible to recruit enough Veterans, the investigators will perform a non-Veteran amendment to this protocol.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
RECRUITINGPittsburgh, Pennsylvania, 15240, United States
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