CompletedNot Applicable

A Comparative Assessment of Transfemoral Prosthetic Sockets

United States29 participantsStarted 2019-08-15

Plain-language summary

The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Socket Fit Comfort Score

Timeframe: After at least 3 weeks of prosthetic socket use

Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)

Timeframe: After at least 3 weeks of prosthetic socket use

Activities Specific Balance Confidence Scale

Timeframe: After at least 3 weeks of prosthetic socket use

Mobility as Measured by the 10-meter Walk Test

Timeframe: after at least 4 weeks of prosthetic socket use

Mobility as Measured by Timed Up and Go (TUG)

Timeframe: after at least 4 weeks of prosthetic socket use

Mobility as Measured by Five Times Sit To Stand (FTSTS)

Timeframe: after at least 4 weeks of prosthetic socket use

Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form

Timeframe: After at least 3 weeks of prosthetic socket use

Trial details

NCT IDNCT04038580

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01

Results submitted2025-07-16

View on ClinicalTrials.gov More Amputation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Socket Fit Comfort Score

Timeframe: After at least 3 weeks of prosthetic socket use

Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)

Timeframe: After at least 3 weeks of prosthetic socket use

Activities Specific Balance Confidence Scale

Timeframe: After at least 3 weeks of prosthetic socket use

Mobility as Measured by the 10-meter Walk Test

Timeframe: after at least 4 weeks of prosthetic socket use

Mobility as Measured by Timed Up and Go (TUG)

Timeframe: after at least 4 weeks of prosthetic socket use

Mobility as Measured by Five Times Sit To Stand (FTSTS)

Timeframe: after at least 4 weeks of prosthetic socket use

Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form

Timeframe: After at least 3 weeks of prosthetic socket use