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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

Who can join

Ages 18 and older · All sexes

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 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

About the study

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.

What is being tested

• Ottobock C-Leg 4 Microprocessor Knee (device)
• Ottobock Kenevo (device)

Sponsor: Hanger Institute for Clinical Research and Education, LLC · Participants: 100 · Started: Jul 11, 2025

Contact the study team

• Shane R. Wurdeman, PhD · Phone: 281-829-4746
• Bretta L. Fylstra, PhD · Phone: 512-994-6685

Official record on ClinicalTrials.gov — NCT06937242

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.