New adjustable socket could help veterans walk more comfortably
NCT ID NCT05989243
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a new adjustable prosthetic socket to a standard rigid socket in 40 veterans with leg amputations. Participants will walk on a treadmill at different speeds while researchers measure how evenly they walk and how comfortable the socket feels. The goal is to find a socket design that improves rehabilitation and daily function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Adjustable Quatro socket (prosthetic device)
- What this could lead to
- If successful, this could lead to better-fitting prosthetic sockets that improve comfort, walking symmetry, and quality of life for people with lower-limb amputations.
- What could go wrong
- This is a small early-stage study with only 40 participants, so results may not apply to everyone. The adjustable socket may not prove significantly better than conventional sockets.
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.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Mar 2027
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.
Who is studied
20 Veterans with unilateral transtibial amputation and 20 Veterans with unilateral transfemoral amputation
- Ages
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18 to 65 years
- 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: * The investigators will enroll up to 40 Veterans * 20 with unilateral transtibial amputation * 20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old * All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation * Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator Exclusion Criteria: * Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)
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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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Rocky Mountain Regional VA Medical Center, Aurora, CO
RECRUITINGAurora, Colorado, 80045-7211, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Walking while thinking: a new training approach may help amputees stay steady
- Shoe choice may change how amputees walk, lab study suggests
- Can a special rehab program help more amputees walk again?
- Mind over matter: mental rehearsal may help amputees walk again
- Mind-Controlled bionic leg: a giant leap for amputees
- New flexible socket could make prosthetics more comfortable for Below-Knee amputees