The Effect of Using Two Different Prosthetic Feet in Patients With Unilateral Transtibial Amputation (NCT04759014) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Using Two Different Prosthetic Feet in Patients With Unilateral Transtibial Amputation
Turkey (Türkiye)42 participantsStarted 2021-02-18
Plain-language summary
Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data.
Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle, NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional capacity, pain severity, satisfaction level and quality of life (QoL) in high activity patients with unilateral transtibial amputation.
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:
* aged 18-65 years
* Medicare functional classification level K4 (very active)
* using the prosthesis for at least 6 months and at least 6 hrs a day
* using active vacuum-assisted suspension system
Exclusion Criteria:
* bilateral amputation,
* the presence of neurological, cardiovascular and pulmonary disease that could affect walking performance.
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
1
Visual Analogue Scale
Timeframe: through study completion, an average of one and a half months
2
Short Form 36 (SF-36)
Timeframe: through study completion, an average of one and a half months
3
The six-minute walking test (6MWT)
Timeframe: through study completion, an average of one and a half months
Trial details
NCT IDNCT04759014
SponsorGaziler Physical Medicine and Rehabilitation Education and Research Hospital