Actively Recruiting
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
Led by Hanger Institute for Clinical Research and Education, LLC · Updated on 2026-02-05
100
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
Sponsors
H
Hanger Institute for Clinical Research and Education, LLC
Lead Sponsor
U
University of Washington
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral transfemoral or knee disarticulation limb loss
- At least 6 months have passed since limb loss
- Current user of a prosthesis with a non-microprocessor-controlled prosthetic knee
- Received a replacement prosthesis with a non-microprocessor knee within the past 4 to 24 months
- Clinician has determined patient is a limited community ambulator (Medicare Functional Level K2)
- Medicare Functional Level K2 confirmed by at least one of: Houghton Score 5-10, PLUS-M T-Score below 49.45 if vascular/diabetes cause or below 36.75 otherwise, or Amputee Mobility Predictor score 27-42 within last 24 months
- Ability to read, write, and understand English
You will not qualify if you...
- Any health condition preventing safe completion of trial activities
- Weight of 275 pounds or more
- Wearing prosthesis less than 3 days a week or less than 24 hours total per week
- History of acute or chronic residual limb breakdown
- Declining health status with reported reduced activity over past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hanger Inc.
Austin, Texas, United States, 78758
Actively Recruiting
Research Team
S
Shane R. Wurdeman, PhD
CONTACT
B
Bretta L. Fylstra, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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