Assessment of Strength, Balance, and Function in Above-Knee Amputees in Relation to Residual Limb… (NCT07032233) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessment of Strength, Balance, and Function in Above-Knee Amputees in Relation to Residual Limb Length
15 participantsStarted 2025-06
Plain-language summary
The goal of this observational study is to learn how muscle strength, balance, and functional ability are affected in people with above-knee (transfemoral) amputations. The main questions it aims to answer are:
How does the length of the lost part of the leg, compared to the intact leg, affect muscle strength, balance, and functional capacity?
Is muscle strength at specific lower limb joints related to balance and performance ?
Participants will:
Have muscle strength measured at all intact lower limb joints using an isokinetic dynamometer
Complete balance assessments using force platform technology that measures weight distribution and evaluates both static and dynamic balance
Perform a six-minute walk test to evaluate endurance and functional capacity
The study will help improve understanding of how limb length and joint-specific muscle strength impact mobility, supporting the development of better rehabilitation programs for amputees.
Who can participate
Age range
18 Years – 50 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:
Individuals will be included in the study if they:
Are between 18 and 50 years of age
Are literate
Have unilateral transfemoral amputation
Have no cardiovascular, orthopedic, cognitive, or neurological conditions that could negatively affect balance, gait, or muscle strength
Are able to ambulate independently with a prosthesis
Have been walking for at least 6 months
Voluntarily agree to participate in the study
Exclusion Criteria:
Participants will be excluded from the study if:
They develop complications such as pain (rated 3 or higher on the Visual Analog Scale) or stump irritation during the course of the study
Their residual limb length is less than 25 cm from the greater trochanter, which exceeds the limitations of the isokinetic dynamometer attachments used in the study
They voluntarily withdraw from the study - in such cases, their data will be removed from the records
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
Length of Residual Limb and Intact Limb (cm) and Percentage of Limb Loss (%)
Timeframe: 1 day
2
Isokinetic Strength Testing
Timeframe: 5 days
3
Stability Coefficient (Eyes Open and Closed), Single-Leg Stability of Intact Side, and Limits of Stability (mm)