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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: Completed NA study, sponsored by University of Illinois at Chicago.

NCT04212299 is a NA study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12.

Interventions

  • DEVICE Northwestern University Flexible Sub-Ischial Suction Socket (NU-FlexSIS)

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2019-09-24
Est. Completion 2023-08-14
Phase NA
University of Illinois at Chicago

430 total trials

What the finished NCT04212299 record still lists

NCT04212299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

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 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04212299's enrollment target sits among peer trials

5 1988th of 2000 higher than 5 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04212299, the US trial registry maintained by the National Library of Medicine. NCT04212299 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.