CompletedNot Applicable

Characterization of Residual Limb Volume Changes in Transfemoral Amputees

Italy24 participantsStarted 2018-05-11

Plain-language summary

This study quantifies residual limb volume fluctuations affecting transfemoral amputees due to the prosthesis doffing, physical activity, and testing time.

Who can participate

Age range

18 Years – 65 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: * Stabilized (i.e., time since amputation \> 18 months) transfemoral amputees * Age between 18 and 65 years old * Subjects able to safely perform the physical tasks required in the experimental protocol * Subjects provided with prostheses Exclusion Criteria: * Denial of informed consent to participate in the study * Inability to maintain the required position during the 3D scanning for at least 5 minutes * Concomitant general or localized comorbidities / disabilities, which may interfere with the study * Pathological conditions affecting the residual limb * Allergy / sensitivity with polydimethylsiloxane (PDMS) * Pathological cardiopulmonary / cardiovascular conditions * Pregnancy or breastfeeding * Presence of psychiatric co-morbidities * Presence of cognitive deficits which may compromise the understanding of the required tasks * Difficulty in understanding the Italian language * Insufficient degree of collaboration * Consumption of alcohol or diuretics before tests

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

Residual limb volume changes

Timeframe: The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks

Trial details

NCT IDNCT04709367

SponsorIstituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-08-31

View on ClinicalTrials.gov More Amputation Stump trials

Who can participate

Age range

18 Years – 65 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.