RecruitingNot ApplicableNCT06937242

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

Fall-related Health Outcome in Lower Limb Prosthesis Users: A Pragmatic Clinical Trial to Assess Effectiveness of Microprocessor-controlled Prosthetic Knees

Sponsor

Hanger Institute for Clinical Research and Education, LLC

Enrollment

100 participants

Start Date

Jul 11, 2025

Study Type

INTERVENTIONAL

Conditions

Amputation Lower Limb Amputation Above Knee (Injury)Limb; Absence, Congenital, Lower Prosthesis User Amputation; Traumatic, Leg: Thigh, Between Hip and Knee Lower Limb Amputation Above Knee

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Ottobock C-Leg 4 Microprocessor Knee and a medical device called Ottobock Kenevo for people with amputation, amputation; traumatic, leg: thigh, between hip and knee, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOttobock C-Leg 4 Microprocessor Knee

Subjects in the intervention group who can walk more than 0.83m/s in the 2-minute walk test (2MWT) will receive the Ottobock C-Leg 4, a stance-and-swing microprocessor knee.

DEVICEOttobock Kenevo

Subjects in the intervention group who can walk up to 0.83m/s (3km/hr) in the 2-minute walk test (2MWT) will receive the Kenevo, a stance-only microprocessor knee.