Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators

Launched by HANGER INSTITUTE FOR CLINICAL RESEARCH AND EDUCATION, LLC · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether microprocessor-controlled prosthetic knees (MPKs) can help improve health outcomes related to falls for adults who have lost a leg above the knee. MPKs are prosthetic knees with built-in computers that can adjust to different walking conditions. The researchers want to know if people using these advanced knees experience fewer falls, can walk faster, and enjoy a better quality of life compared to those using traditional prosthetic knees without this technology.

To participate, individuals must have lost one leg above the knee and have been using a traditional prosthetic knee for at least a year. They should also have been assessed as having limited mobility, which means they can walk but may need some assistance. Participants will be randomly assigned to either continue using their traditional knee or to switch to an MPK. While the study is not yet recruiting participants, it’s important for potential volunteers to know that they should be in good health and able to use their prosthesis regularly.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Unilateral transfemoral or knee disarticulation limb loss.
• • 12 months or longer since time of limb loss.
• • Current user of a prosthesis with a non-microprocessor-controlled prosthetic knee.
• • Received a replacement prosthesis with a non-microprocessor knee in the past 4-24 months.
• • Clinician has deemed patient limited community ambulator (Medicare functional classification level K2).
• * In addition, Medicare functional classification level K2 as determined by at least one of the following criteria:
• • 1. Houghton Score: 5-10
• • 2. Prosthetic Limb Users Survey of Mobility (PLUS-M) T-Score: if amputation etiology is vascular disease/diabetes \<49.45, otherwise, \<36.75.
• • 3. Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months
• • Ability to read, write, and understand English.
• Exclusion Criteria:
• • Any health condition that would prevent safely completing trial activities.
• • Any individuals that weigh 275 lbs or more.
• • Any individuals who wear their prosthesis less than 3 days a week or less than a total of 24 hours a week
• • Individuals with a history of acute or chronic residual limb breakdown
• • Individuals with declining health status such that he/she subsequently reports reduced activity over the past 6 months