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

Inclusion Criteria10

Unilateral transfemoral or knee disarticulation limb loss.
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:
Houghton Score: 5-10
Prosthetic Limb Users Survey of Mobility (PLUS-M) T-Score: if amputation etiology is vascular disease/diabetes \<49.45, otherwise, \<36.75.
Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months
Ability to read, write, and understand English.

Exclusion Criteria5

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

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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.