MedTrace Logo

Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators

NCT06937242 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-05

No results posted yet for this study

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.

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

Interventions

DEVICE

Ottobock 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.

DEVICE

Ottobock 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.

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • U.S. Army Medical Research Acquisition Activity

    collaborator FED

  • Hanger Institute for Clinical Research and Education, LLC

    lead INDUSTRY

Principal Investigators

  • Shane R. Wurdeman, PhD · Hanger Institute for Clinical Research and Education

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06937242 on ClinicalTrials.gov