New device aims to take the guesswork out of prosthetic fit
NCT ID NCT07491614
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new, non-invasive device that attaches to the outside of a prosthetic leg socket to measure how well it fits. Poor socket fit can cause pain, skin problems, and reduced mobility. The device tracks movement and accuracy as users perform a simple task, aiming to provide objective fit data. The pilot study will enroll 18 adults with above-knee amputations to see if the device is reliable and valid.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Prosthetic socket fit testing system
- What this could lead to
- If successful, this device could provide a quick, non-invasive way to check prosthetic socket fit, helping prosthetists make adjustments that reduce pain and improve mobility.
- What could go wrong
- This is a very small pilot study with only 18 participants, so results may not apply to everyone. The device is still a prototype and may not prove accurate or practical in real-world use.
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 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: * be between 18 and 70 years old * have a unilateral transfemoral amputation * be at least 12 months post-amputation * have a residual limb that is free of open wounds or infections * wear a prosthesis for a minimum of four hours per day * be able to ambulate short distances with a prosthesis * be able to stand on the intact leg for brief periods * be able to hold onto parallel bars with the arms for balance * have pain-free range of motion at the hip on the amputated side * have no back problems that make standing or hip movement difficult * have corrected vision that is sufficient to see the cursors on the screen * be able to follow simple instructions in English Exclusion Criteria: * residual limb issues (e.g. sensitive or frail skin) that may be made worse by testing * a prosthetic socket that cannot be disconnected from the distal prosthetic components * unable to read and speak English
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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 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.
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Other studies related to the condition(s) this trial covers.
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