Effect of a Microprocessor-controlled Prosthetic Knee Joint on K2 Level Ambulators
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
Qualifiers
Unilateral, transfemoral amputation (any etiology).
Age from 45-85 years.
Residual limb length classified as standard (i.e., medium) to long.
Prosthesis user for at least 1 year prior to enrolling in the study.
Disqualifiers
Bilateral leg amputations.
Individuals with a knee disarticulation.
Trial design
Treatments tested in this trial
- College Park ICON
- Conventional NMPK
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov