Functional Performance Evaluation of NU-FlexSIV Socket

Completed · Not applicable

Conditions studied: Amputation, Artificial Limbs

In brief

The overall objective of this study is to provide a more comfortable and functional prosthetic socket for persons with transfemoral amputation that will ultimately improve their quality of life.

Key facts

Study ID

NCT02678247

Run by

Northwestern University

People needed

30

Starts

2016-04-01

Expected to finish

2019-12-01

Last updated by the study team

2021-06-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• unilateral transfemoral amputation
• have used a prosthesis for two or more years
• have a residual limb that is stable in volume and free from wounds
• be physically fit enough to participate in the performance tests (Medicare Functional Classification Level K3 or K4)
• have no previous experience of the sub-ischial socket
• able to complete all visits for the duration of the protocol

You may not qualify if…

• have a residual limb femur of less than 5-inches
• co-morbidities that affect function, including neurologic abnormalities (e.g. neuropathic pain that would interfere with the study)
• do not speak and read English

Where it is running

• Jesse Brown VA Medical Center Motion Analysis Research Laboratory — Chicago, Illinois, United States
• Northwestern University Prosthetics-Orthotics Center — Chicago, Illinois, United States
• Scheck and Siress Prosthetics Orthotics — Oakbrook Terrace, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.