A Study of Performance of a New Investigational Prosthesis Design and Explore How Mimicking the Human Ankle May Enhance Maneuverability of Walking

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-006800
    Sponsor Protocol Number: 16-006800

About this study

The purpose of this study is to see how you walk with an investigational new type of ankle-foot prosthesis that has been developed, which can allow motion in more than one direction.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:        

  • Unilateral transtibial amputee
  • Medicare Functional Classification Level K3 or K4
  • A minimum of 1 year experience as an amputee
  • Current prosthesis is well fitting at the socket

Exclusion Criteria: 

  • Additional nueromusculoskeletal condition(s) affecting gait

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenton Kaufman, Ph.D.

Open for enrollment

Contact information:

Kathie Bernhardt

(507)266-0985

Bernhardt.Kathie@mayo.edu

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CLS-20304534

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