The distance function effect on k-nearest neighbor classification for medical datasets.
Li-Yu Hu, Min-Wei Huang, Shih-Wen Ke...
https://pubmed.ncbi.nlm.nih.gov/27547678Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06937242
Fall-related Health Outcome in Lower Limb Prosthesis Users: A Pragmatic Clinical Trial to Assess Effectiveness of Microprocessor-controlled Prosthetic Knees
Led by Hanger Institute for Clinical Research and Education, LLC · Updated on 2026-02-05
100
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating whether microprocessor-controlled prosthetic knees (MPKs), which have built-in computers, improve health outcomes related to falls in adults who use above-knee prostheses. This study focuses on users classified as limited community ambulators (Medicare Functional Level K2) and aims to find out if MPKs reduce fall-related health issues, increase mobility and walking speed, and enhance quality of life compared to non-microprocessor-controlled prosthetic knees (nMPKs). The study is a 12-month randomized control trial where participants who recently received an nMPK are assigned to either continue using their nMPK or switch to an MPK. Those receiving the MPK will get either a stance-and-swing MPK (Ottobock C-Leg 4) or a stance-only MPK (Ottobock Kenevo), based on their walking speed measured by a 2-minute walk test. Participants will undergo education and training specific to their prosthetic knee and will wear the assigned knee for the full study duration. Participants will be assessed at baseline and at 1, 3, 6, 9, and 12 months, with primary assessments at baseline and 12 months. Researchers will collect data on fall-related self-efficacy, anxiety, avoidance behaviors, interference, and the number of falls every two weeks. Mobility, walking speed, endurance, quality of life, and prosthesis wear and activity hours will also be measured. Fall and near-fall events, including injuries and treatments, will be closely monitored throughout the study.
CONDITIONS
Brief Title
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Unilateral transfemoral or knee disarticulation limb loss
- At least 6 months since limb loss
- Current user of a prosthesis with a non-microprocessor-controlled knee
- Received a replacement prosthesis with a non-microprocessor knee in the past 4 to 24 months
- Classified as a limited community ambulator (Medicare Functional Level K2) by clinician
- Meets at least one of these: Houghton Score 5-10; PLUS-M T-Score below 49.45 (if vascular/diabetes) or below 36.75 (otherwise); AMPPRO 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 participation in trial activities
- Weight of 275 pounds or more
- Wearing prosthesis less than 3 days per week or less than 24 hours per week total
- History of acute or chronic residual limb breakdown
- Declining health with reduced activity over past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Enrollment and Baseline Assessment
Duration - Up to 1 day
Eligible participants are consented, randomized, and complete baseline assessments including performance tests and self-report surveys related to fall-related health and mobility.
1 baseline visit (in-person)
Device Implementation and Training
Duration - Between baseline and 1-month follow-up
Participants randomized to the intervention group receive a microprocessor-controlled prosthetic knee (MPK) based on walking speed, while control group participants continue using their prescribed non-microprocessor knee (nMPK). All participants receive 1 to 4 training sessions to facilitate prosthesis use.
1 to 4 training sessions (in-person)
Treatment and Outcome Assessments
Duration - 12 months
Participants wear their assigned prosthetic knee and complete follow-up assessments of fall-related health outcomes and mobility at 1, 3, 6, 9, and 12 months after baseline, including standardized tests and self-report surveys.
5 follow-up visits (in-person) at 1, 3, 6, 9, and 12 months
Ongoing Monitoring of Falls and Near-Fall Events
Duration - 12 months
Participants report the number of falls and near-fall events every two weeks throughout the 12-month participation period, including details on injury and prosthesis use during the event.
Biweekly check-ins (remote or in-person) every 2 weeks
Trial Site Locations
Total: 1 location
1
Hanger Inc.
Austin, Texas, United States, 78758
Actively Recruiting
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Research Team
S
Shane R. Wurdeman, PhD
B
Bretta L. Fylstra, PhD
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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Published Research Related To This Trial
Microprocessor prosthetic knees.
Dale Berry
https://pubmed.ncbi.nlm.nih.gov/16517347How to do random allocation (randomization).
Jeehyoung Kim, Wonshik Shin
https://pubmed.ncbi.nlm.nih.gov/24605197Blocked randomization with randomly selected block sizes.
Jimmy Efird
https://pubmed.ncbi.nlm.nih.gov/21318011Impact of a stance phase microprocessor-controlled knee prosthesis on level walking in lower functioning individuals with a transfemoral amputation.
Valerie J Eberly, Sara J Mulroy, JoAnne K Gronley...
https://pubmed.ncbi.nlm.nih.gov/24135259Differences in function and safety between Medicare Functional Classification Level-2 and -3 transfemoral amputees and influence of prosthetic knee joint control.
Brian J Hafner, Douglas G Smith
https://pubmed.ncbi.nlm.nih.gov/19675993Evaluation of function, performance, and preference as transfemoral amputees transition from mechanical to microprocessor control of the prosthetic knee.
Brian J Hafner, Laura L Willingham, Noelle C Buell...
https://pubmed.ncbi.nlm.nih.gov/17270519A comparative evaluation of the Adaptive knee and Catech knee joints: a preliminary study.
F Jepson, D Datta, I Harris...
https://pubmed.ncbi.nlm.nih.gov/18330807Comparison of nonmicroprocessor knee mechanism versus C-Leg on Prosthesis Evaluation Questionnaire, stumbles, falls, walking tests, stair descent, and knee preference.
Jason T Kahle, M Jason Highsmith, Sandra L Hubbard
https://pubmed.ncbi.nlm.nih.gov/18566922Falls sustained during inpatient rehabilitation after lower limb amputation: prevalence and predictors.
Tim Pauley, Michael Devlin, Kathleen Heslin
https://pubmed.ncbi.nlm.nih.gov/16715022