Comparative Performance of Dynamic Elastic Response Feet
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
Site IRB
- Rochester, Minnesota: 15-001367
NCT ID: NCT02542761
Sponsor Protocol Number: 15-001367
About this study
The purpose of this study is to compare the functional performance of individuals with transtibial amputation using two types of prosthetic foot designs: carbon fiber versus fiberglass composite.
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Unilateral transtibial amputee
- Currently using a carbon fiber prosthetic (DER) foot for at least the last 6 months
- Stable stump volume over the past 6 months
- Medicare Functional Classification Level K3 or K4
Exclusion Criteria
- Neuromuscular problems such as previous stroke or contralateral amputation
- Use of gait aids for ambulation
- Undergoing dialysis
- Poor prosthetic socket fit or stump problems (e.g., skin breakdown)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Kenton Kaufman, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available