The Investigations of Core Muscles, Gait, Balance and Proprioception in Transtibial Amputees (NCT07203235) | Clinical Trial Compass
CompletedNot Applicable
The Investigations of Core Muscles, Gait, Balance and Proprioception in Transtibial Amputees
Turkey (Türkiye)26 participantsStarted 2025-09-29
Plain-language summary
The goal of this observational study is to investigate the effects of transtibial amputation on core function and endurance, and their relationship with proprioception, balance, and gait in adults with transtibial amputation and healthy controls.
The main questions it aims to answer are:
Do individuals with transtibial amputation show reduced core function and endurance compared to non-amputees?
Is there a relationship between core function/endurance and proprioception, balance, and gait performance in transtibial amputees?
Researchers will compare individuals with transtibial amputation to non-amputee individuals to see if there are significant differences in core endurance, posture, and functional abilities.
Participants will:
Perform tests to assess core function and muscular endurance
Undergo evaluations of proprioception, balance, and gait
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 (for Amputee Group):
* Age between 18 and 50 years
* Unilateral transtibial amputation
* Use of a prosthesis for at least 6 months
* Medicare Functional Classification Level (MFCL) of K2 or higher (indicating the ability to ambulate in the community)
* Willingness to participate and provide informed consent
Inclusion Criteria (for Control Group):
* Age between 18 and 50 years
* Willingness to participate and provide informed consent
Exclusion Criteria (for Amputee Group):
* Presence of any neurological disorder
* Presence of any mental health disorder
* Any orthopedic condition (other than amputation) within the past 12 months
* Pregnancy
* Use of a walking aid (e.g., cane, walker)
Exclusion Criteria (for Control Group):
* Presence of any neurological disorder
* Presence of any mental health disorder
* Any orthopedic condition within the past 12 months
* Pregnancy
* Use of a walking aid (e.g., cane, walker)
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
Knee Joint Position Sense (Proprioception)
Timeframe: Single assessment at time of participant enrollment