Study of Microprocessor-Controlled Prosthetic Knees to Improve Fall-Related Health and Mobility in Adults Using Above-Knee Prostheses

What this Trial Is About

Researchers are evaluating whether microprocessor-controlled prosthetic knees MPKs, which have built-in computers, improve health outcomes related to falls in adults who use above-knee prostheses. This study focuses on users classified as limited community ambulators Medicare Functional Level K2 and aims to find out if MPKs reduce fall-related health issues, increase mobility and walking speed, and enhance quality of life compared to non-microprocessor-controlled prosthetic knees nMPKs. The study is a 12-month randomized control trial where participants who recently received an nMPK are assigned to either continue using their nMPK or switch to an MPK. Those receiving the MPK will get either a stance-and-swing MPK Ottobock C-Leg 4 or a stance-only MPK Ottobock Kenevo, based on their walking speed measured by a 2-minute walk test. Participants will undergo education and training specific to their prosthetic knee and will wear the assigned knee for the full study duration. Participants will be assessed at baseline and at 1, 3, 6, 9, and 12 months, with primary assessments at baseline and 12 months. Researchers will collect data on fall-related self-efficacy, anxiety, avoidance behaviors, interference, and the number of falls every two weeks. Mobility, walking speed, endurance, quality of life, and prosthesis wear and activity hours will also be measured. Fall and near-fall events, including injuries and treatments, will be closely monitored throughout the study.

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