Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
Hanger Institute for Clinical Research and Education, LLC · with University of Washington, U.S. Army Medical Research Acquisition Activity · NCT06937242
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- July 11, 2025
- Record last updated
- February 5, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Ottobock C-Leg 4 Microprocessor Knee; Ottobock Kenevo
Conditions: Amputation; Prosthesis User; Amputation; Traumatic, Leg: Thigh, Between Hip and Knee; Limb; Absence, Congenital, Lower; Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Above Knee
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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:
- 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 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
Recruiting US locations
Hanger Inc.
Austin, TX 78758
Site contact: Shane R. Wurdeman, PhD · 281-829-4746 · swurdeman@hanger.com
Study contacts (from the official record)
- Shane R. Wurdeman, PhD · 281-829-4746 · swurdeman@hanger.com
- Bretta L. Fylstra, PhD · 512-994-6685 · bfylstra@hanger.com