Improving balance and control for below-knee amputees using advanced prosthetics
Toward Restoration of Normative Postural Control and Stability Using Neural Control of Powered Prosthetic Ankles
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | North Carolina State University Academic / other |
| Locations | 1 site (Raleigh, North Carolina) |
| Trial ID | NCT06452186 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Raleigh, North Carolina
- North Carolina State University — Raleigh, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: He Huang, PhD — NC State University
- Study coordinator: Neuromuscular Rehabilitation Engineering Laboratory
- Email: nrel.ncsu.contact@gmail.com
- Phone: 919-513-3840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.