Status:
COMPLETED
A Comparative Assessment of Transfemoral Prosthetic Sockets
Lead Sponsor:
University of Michigan
Conditions:
Amputation
Amputation; Traumatic, Leg, Lower
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.
Detailed Description
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making. The investigators will explore a range of outcomes t...
Eligibility Criteria
Inclusion
- Unilateral lower-limb amputation
- Six months of independent ambulation
- Own and regularly wear a prosthesis with socket
- Minimum functional level of K2 on the Medicare Functional Classification Level (MFCL): corresponding to "the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator"
Exclusion
- Pathology or injury of the intact limb
- Medication that affects their ability to walk
- Neurologic or cardiovascular disease
- Significant vision problems
- Suffer from an impaired mental capacity that negatively impacts verbal communication with the clinicians and research team, or requires a Legally Authorized Representative to facilitate communication
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04038580
Start Date
August 15 2019
End Date
July 1 2024
Last Update
September 29 2025
Active Locations (2)
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1
Rosalind Franklin University
Chicago, Illinois, United States, 60064
2
University of Michigan
Ann Arbor, Michigan, United States, 48109