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Recruiting NCT06937242

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

Trial Parameters

Condition Amputation
Sponsor Hanger Institute for Clinical Research and Education, LLC
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-07-11
Completion 2027-02
Interventions
Ottobock C-Leg 4 Microprocessor KneeOttobock Kenevo

Brief Summary

The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses. The main questions are: * Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)? * Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs? Participants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.

Eligibility Criteria

Inclusion Criteria: * Unilateral transfemoral or knee disarticulation limb loss. * 6 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 wea

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