Effect of a Microprocessor-controlled Prosthetic Knee Joint on K2 Level Ambulators

Part of paid clinical trials in Chicago, Illinois.

Sponsor
VA Office of Research and Development
Study ID
NCT07103798
Status
Not Yet Recruiting

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Conditions

  • Limb Absence
  • Limb Loss
  • Transfemoral Amputation

Eligibility Criteria

Sex
ALL
Age
45 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • College Park ICON — OTHER
    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.
  • Conventional NMPK — OTHER
    Subjects will be tested walking with their conventional, mechanical prosthetic knee prior to being fitted with the MPK.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
May 1, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: MPK
    Subjects will be fitted with the College Park ICON MPK and permitted to accommodate for 2 months prior to data collection.
  • Active Comparator: NMPK
    Subjects will initially be evaluated walking on their conventional NMPK as a baseline prior to being fitted with the MPK.

Primary Outcome Measure

Walking speed [ Time Frame: To be measured before and immediately following the 2-month accommodation period of wearing the MPK. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Jesse Brown VA Medical Center, Chicago, ILChicagoIllinois60612
Rebecca Stine, MS
[email protected]
312-503-5726
Steven A Gard, PhD
[email protected]
(312) 503-5718
Steven A Gard, PhD (PRINCIPAL_INVESTIGATOR)
Edward Hines Jr. VA Hospital, Hines, ILHinesIllinois60141-3030
Rebecca Stine, MS
[email protected]
312-503-5726
Steven A Gard, PhD
[email protected]
3125035718

Find similar trials in Chicago, IL

By research site
Jesse Brown VA Medical Center, Chicago, IL· Chicago, ILEdward Hines Jr. VA Hospital, Hines, IL· Hines, IL

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