Effect of a Microprocessor-controlled Prosthetic Knee Joint on K2 Level Ambulators
NCT07103798 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-05-08
Summary
Microprocessor-controlled knees (MPKs) automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the prosthesis user during gait. The purpose of this proposed investigation is to determine if there are substantial physical and psychological benefits to fitting lower functioning Veteran ambulators having transfemoral amputations with an MPK compared with a nonmicroprocessor-controlled knee (NMPK). Using a repeated-measures, cross-sectional experimental design, approximately 20 Veterans with unilateral, transfemoral amputations will be evaluated on two separate occasions at the Jesse Brown VA Medical Center or the Edward Hines, Jr. VA Hospital, first with their conventional NMPK and then again after a 2-month accommodation period with the College Park Icon MPK.
Conditions
- Transfemoral Amputation
- Limb Loss
- Limb Absence
Interventions
- OTHER
-
College Park ICON
Subjects will be fitted and trained on the College Park ICON MPK. An accommodation period of 2 months will be provided prior to evaluation with the knee joint.
- OTHER
-
Conventional NMPK
Subjects will be tested walking with their conventional, mechanical prosthetic knee prior to being fitted with the MPK.
Sponsors & Collaborators
-
VA Office of Research and Development
lead FED
Principal Investigators
-
Steven A Gard, PhD · Jesse Brown VA Medical Center, Chicago, IL
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 45 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2028-05-01
- Completion
- 2028-06-30
Countries
- United States
Study Locations
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