Impact of Powered Knee-Ankle Prosthesis Leg on Everyday Community Mobility and Social Interaction (NCT03204513) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impact of Powered Knee-Ankle Prosthesis Leg on Everyday Community Mobility and Social Interaction
United States15 participantsStarted 2016-12
Plain-language summary
The overall goal of this research is to determine the efficacy of new powered prosthetic devices for individuals with transfemoral amputations. The anticipation is that this will be a high-impact technological intervention with the potential to restore significant functionality to individuals with lower limb amputation and transform the field of lower limb prosthetics. The objective of the proposed clinical trial is to fully evaluate the biomechanical and energetic effects of using PKA prosthesis and quantify functional performance and quality of life changes.
Who can participate
Age range
18 Years – 80 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:
* Unilateral transfemoral level limb loss or limb difference
* K2/K3/K4 level ambulators
* Required to use a microprocessor knee on their prosthesis
Exclusion Criteria:
* Over 250 lbs body weight
* Inactive, physically unfit
* Cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments
* Pregnant women
* Co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)
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 between devices of the Modified Graded Treadmill Test