Improving prosthetic socket fit for veterans with lower limb amputations
Official title: Improving Socket Fit in Female and Male Veterans With Transtibial and TransfemoralAmputation
Run by VA Office of Research and Development · NCT05989243 · Data updated 2026-11-12
This study is testing whether an adjustable prosthetic socket can help veterans with lower limb amputations walk better and feel more comfortable compared to a regular socket.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | January 31, 2022 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT05989243 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are veterans aged 18-65 with unilateral transtibial or transfemoral amputations who are at or above a K2 Medicare functional classification level.
✕Probably not a fit
Patients with cardiovascular, pulmonary, or neurological disorders, or those requiring assistive devices for their unaffected leg, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to compare the performance of an adjustable prosthetic socket with a conventional socket in veterans who have undergone transtibial or transfemoral amputation. The study will involve 40 veterans, split evenly between the two types of amputations, to assess biomechanical asymmetry, socket pistoning, and overall comfort and satisfaction. Participants will be evaluated on their ability to ambulate and navigate various environmental barriers, providing insights into which socket design may enhance rehabilitation and functional outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved prosthetic designs that enhance mobility and comfort for veterans with lower limb amputations.
How similar studies have gone: While this approach is novel in its specific focus on adjustable sockets for veterans, similar studies have shown promise in improving prosthetic designs and patient outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States Recruiting
Study contacts
- Principal investigator: Alena Grabowski, PhD BA — Rocky Mountain Regional VA Medical Center, Aurora, CO
- Study coordinator: Alena Grabowski, PhD BA
- Email: Alena.Grabowski@va.gov
- Phone: (720) 435-4270
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Footwear effects on walking in people with a leg prosthesis
This study tests four different types of footwear to see how they affect walking in adults with a unilateral transtibial amputation who use a prosthetic foot.
-
Access Socket: a flexible prosthetic socket for transtibial amputation
This trial tests whether the Access Socket, a hybrid flexible socket, improves comfort and function for adults with transtibial amputations compared with standard rigid sockets.
-
E-SWEAT wearable sensors to monitor residual limb health
This trial tests a wearable sensor system that measures pressure, temperature, and lactic acid in sweat inside prosthetic sockets for adults with below-knee (transtibial) amputations.
-
Personalizing powered knee prostheses using reinforcement learning
This trial will test whether a computer system called RISE can help clinicians tune powered knee prostheses faster and make them work better for people with above-knee (transfemoral) amputations.
-
Neural-controlled powered knee and ankle for people with above-knee amputation.
We will test whether a neural-controlled powered knee or ankle prosthesis helps people with above-knee (transfemoral) amputation walk more naturally and stably in everyday situations.
-
How residual limb length relates to strength, balance, and function after transfemoral amputation
This study tests how the length of the missing lower leg segment affects strength, balance, and daily function in adults with a transfemoral amputation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.