Actively Recruiting
Toward Restoration of Normative Postural Control and Stability Using Neural Control of Powered Prosthetic Ankles
Led by North Carolina State University · Updated on 2026-04-13
50
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
N
North Carolina State University
Lead Sponsor
U
University of North Carolina, Chapel Hill
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how training with direct electromyographic (dEMG) control of a powered prosthetic ankle affects people with below-knee amputations. The study aims to find out if dEMG control improves balance and postural stability, leads to more natural muscle control and coordination, and reduces cognitive effort during movement. It compares outcomes between participants using dEMG-controlled powered prostheses and those using their usual passive prosthetic ankles. Participants will attend up to 15 lab visits involving physical therapy-guided training. Initial visits include consent, baseline measurements, and validation of the prosthetic interface. Participants are randomized into two groups: one trains with the dEMG-controlled powered prosthetic ankle, and the other with their own passive prosthesis. Training focuses on muscle coordination and integrating prosthesis movement with full body motion. Follow-up visits evaluate effects immediately post-training and three months later. Throughout the study, participants complete functional tasks assessing balance, muscle coordination, and cognitive load. Measurements include anticipatory center of mass excursion, stepping response frequency, ankle torque coordination, prosthesis embodiment, and mobility scores. Each participant is evaluated using both prosthesis types at multiple timepoints. The study lasts several months, with close monitoring of performance changes and long-term training effects.
CONDITIONS
Brief Title
Restoration of Normative Postural Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Unilateral lower limb amputation below the knee
- K-level 2 or higher (frequent prosthesis user likely to benefit from training)
- Amputation occurred more than 2 years ago
- At least 1 year of prosthetic leg use
- Current socket used for at least 6 months without significant skin issues or modifications
- Willing to participate in research at NC State University and be photographed during activities
You will not qualify if you...
- Residual limb length 15% or less of intact limb length
- Unable to walk daily in the community without assistive devices
- Cognitive or visual impairments affecting consent or following instructions
- Congenital amputation
- Use of powered prosthetic ankles
- Weight over 300 pounds
- Pregnant person
- Allergy to latex often found in medical tapes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and initial measurements
Duration - 2 visits over 1 to 2 weeks
Participants complete baseline evaluations using both their own passive prosthesis and the powered prosthetic ankle to assess initial performance.
2 visits (in-person)
Duration - 9 visits over several weeks
Participants receive training to regain muscle coordination and integrate the prosthetic ankle with full body motion, using either the powered or passive prosthetic leg depending on group assignment.
9 visits (in-person)
Duration - 2 visits within 1 to 2 weeks after training
Participants are evaluated again to measure the impact of the training program on their performance with both prosthetic devices.
2 visits (in-person)
Duration - 2 visits around 3 months post post-training evaluation
Participants return approximately three months later for long-term follow-up evaluations to assess lasting effects of the training program.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
North Carolina State University
Raleigh, North Carolina, United States, 27695
Actively Recruiting
Research Team
N
Neuromuscular Rehabilitation Engineering Laboratory
M
Ming Liu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here