Bio Leg: Advancing Mobility (NCT07613502) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Bio Leg: Advancing Mobility
United States12 participantsStarted 2026-06-01
Plain-language summary
Following transfemoral amputation, regaining functional mobility, particularly the ability to navigate curbs, ramps, long distances, and the ability to stand is challenging and often unattainable. Use of advanced prosthetic limb technology can dramatically influence mobility outcomes. The purpose of this study is to compare walking function in individuals with transfemoral amputations who are current users of the C-leg (current clinical standard) to function achieved when using the Bio Leg powered micro-processor prosthetic knee.
Who can participate
Age range
40 Years – 70 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:
* Adults 40 to 70 years of age
* Unilateral transfemoral amputation \> 1 year
* K3 or K4 ambulator and able to walk with no greater assistances than a single point cane
* Current microprocessor-controlled prosthesis (C-leg) user with \> 6 months experience and able to walk without a device of using a single point cane
* Able to give informed consent
Exclusion Criteria:
* Severe cardiovascular condition or other disease limiting study participation
* Skin lesions or wounds, acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking activities
* Residual limb dysfunction (i.e. joint contracture) limiting mobility or study participation
* Pain that limits walking of participation in walking activities
* Current participation in rehabilitation to address walking function
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
Change in 6-Minute Walk Test (6MWT)
Timeframe: Baseline, 4-6 weeks
2
Change in Interlimb Symmetry (Ground Reaction Forces)