Restoration of Normative Postural Control (NCT06452186) | Clinical Trial Compass
RecruitingNot Applicable
Restoration of Normative Postural Control
United States50 participantsStarted 2023-10-01
Plain-language summary
The objective of this proposal is to investigate the effects of training to use direct electromyographic (dEMG) control of a powered prosthetic ankle on transtibial amputees'.
The aimed questions to answer:
1. whether dEMG control will improve balance and postural stability of amputees,
2. whether dEMG control will lead to more natural neuromuscular control and coordination, 3) whether dEMG control will reduce cognitive processes.
Participants will go through PT guided training on using dEMG controlled prosthetic ankles and are evaluated for their capability on functional tasks.
The results will be compared with a comparison group, which goes through the same training but with their everyday passive prostheses on balance capability, neuromuscular coordination, and cognitive load during locomotion.
Who can participate
Age range
18 Years – 99 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:
* 18 years or older;
* unilateral bower limb amputee
* K-level 2 or higher (who are frequent prosthesis users and may benefit from the proposed prosthesis training and use of dEMG controlled powered prosthesis)
* Amputation occurred over 2 years ago
* At least 1 year of experience using their prosthetic leg
* Has used the current socket for at least 6 months without a significant skin issue or major modification
* Are willing to come to NC State University's Centennial Campus to participate in research and be photographed while doing research activities
Exclusion Criteria:
* Have a very short residual shank (the length of the residual limb is ≤15% of the length of intact limb)
* Cannot perform functional ambulation in the community on a daily basis without assistive devices
* Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments
* Congenital amputees
* Amputees who use powered prosthetic ankles
* Weight more than 300lbs
* Pregnant Person
* Allergic to latex, which is often contained in medical tapes.
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
aCOM, anticipatory Center of Mass Excursion when the expected disturbance is introduced
Timeframe: Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices