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NCT04212299 · ClinicalTrials.gov registry record · NA
Transfemoral Socket Design and Muscle Function
A NA study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT04212299 is a NA study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 5 participants.
The verdict
NCT04212299, a NA study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
The objective of this pilot research project is to evaluate the effect of prosthetic socket design on amputated limb hip muscle strength and endurance in Service members, Veterans, and civilians who use above-the-knee prostheses. Traditional above-the-knee socket designs provide pelvic support that interferes with hip motion. They may also reduce the effort required from amputated limb hip muscles to stabilize the hip and amputated limb, risking further loss of muscle mass and strength beyond that due to amputation. Long-standing use of above-the-knee sockets with pelvic support may therefore intensify amputated limb muscle loss and weakness, leading to challenges with walking and balance, increasing the effort required to walk, and contributing to degenerative changes in the hips and knees. Alternative socket designs that lessen the loss of muscle mass and strength are therefore required. The investigators have developed a new socket without pelvic support for above-the-knee prosthesis users called the Northwestern University Flexible Sub-Ischial Suction (NU-FlexSIS) Socket. This new socket design increases user comfort and is often preferred by users over sockets with pelvic support. This new socket does not lessen the mechanical function of the socket, or walking and balance performance. Our recent research suggests that walking with this new socket may also increase amputated limb hip muscle size. However, more research is needed to demonstrate that this new socket design improves amputated limb hip muscle strength and endurance, leading to better function. A socket design that increases amputated limb hip muscle strength and endurance would provide a simple way to restore amputated limb hip muscle weakness in above-the-knee prosthesis users. Despite a considerable decrease in hip muscle size and strength due to amputation surgery, amputated limb hip muscles are expected to compensate for the loss of knee and ankle function by providing stability and propulsio
Interventions
- DEVICE Northwestern University Flexible Sub-Ischial Suction Socket (NU-FlexSIS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-09-24 |
| Est. Completion | 2023-08-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04212299
The ClinicalTrials.gov registry entry for NCT04212299 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Northwestern University Flexible Sub-Ischial Suction Socket (NU-FlexSIS) is the first listed.
NCT04212299 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04212299 about?
NCT04212299 is a clinical study titled "Transfemoral Socket Design and Muscle Function". The objective of this pilot research project is to evaluate the effect of prosthetic socket design on amputated limb hip muscle strength and endurance in Service members, Veterans, and civilians who use above-the-knee prostheses. Traditional above-the-knee socket designs provide pelvic support that ...
What is the current status of trial NCT04212299?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2019-09-24. Estimated completion is 2023-08-14.
What interventions are being tested in trial NCT04212299?
The interventions under investigation include: Northwestern University Flexible Sub-Ischial Suction Socket (NU-FlexSIS) (DEVICE).
Who is sponsoring clinical trial NCT04212299?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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