Clinical trial Recruiting at 1 site Interventional Ages 18 to 99

Improving balance and control for below-knee amputees using advanced prosthetics

Official title: Toward Restoration of Normative Postural Control and Stability Using Neural Control of Powered Prosthetic Ankles

Run by North Carolina State University · NCT06452186 · Data updated 2026-11-12

This study tests if using advanced powered prosthetic ankles controlled by muscle signals can help people with below-knee amputations improve their balance and movement compared to regular prosthetics.

Quick facts

Study typeInterventional
Ages18 Years to 99 Years
SexAll
Enrollment50 (estimated)
SponsorNorth Carolina State University
Academic / other
Locations1 site (Raleigh, North Carolina)
StatusRecruiting
StartedOctober 1, 2023
Main results expectedMay 30, 2028
Study endsJuly 30, 2028
Registry record updatedJuly 14, 2026
Trial IDNCT06452186 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are unilateral below-knee amputees aged 18 or older, with at least one year of experience using their prosthetic leg and a K-level of 2 or higher.

Probably not a fit

Patients with very short residual limbs, cognitive or visual impairments, or those who cannot ambulate independently may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of direct electromyographic (dEMG) control on powered prosthetic ankles for individuals with below-knee amputations. Participants will undergo physical therapy-guided training to enhance their balance, postural stability, and neuromuscular coordination while using a powered prosthetic. The study compares outcomes between those using dEMG-controlled prosthetics and those using standard passive prosthetics. Evaluations will focus on functional tasks and cognitive load during locomotion across multiple lab visits.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the mobility and quality of life for below-knee amputees.

How similar studies have gone: While the use of powered prosthetics is an emerging field, studies exploring dEMG control have shown promising results, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • North Carolina State University
    Raleigh, North Carolina, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.