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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHanger Institute for Clinical Research and Education, LLC

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ottobock C-Leg 4 Microprocessor Knee
  • Ottobock Kenevo

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hanger Institute for Clinical Research and Education, LLC

Lead sponsor

University of Washington

Collaborator

U.S. Army Medical Research Acquisition Activity

Collaborator