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Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation

Recruitingn/aAges 18 Years - 65 YearsAllVA Office of Research and Development
NCT05989243 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.

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📋 Eligibility rules (as published)
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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What it tests

  • Conventional prosthetic socket
  • Adjustable Quatro socket
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Where

1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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