Improving prosthetic socket fit for veterans with lower limb amputations
Improving Socket Fit in Female and Male Veterans With Transtibial and TransfemoralAmputation
VA Office of Research and Development · NCT05989243
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05989243 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aurora, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Transtibial Amputation, Transfemoral Amputation, Biomechanics, Kinematics, Walking, Prostheses