NCT06452186 Restoration of Normative Postural Control
| NCT ID | NCT06452186 |
| Status | Recruiting |
| Phase | — |
| Sponsor | North Carolina State University |
| Condition | Lower Limb Amputation Below Knee (Injury) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2028-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-10-01 with a primary completion date of 2028-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
He Huang, PhD
PRINCIPAL INVESTIGATOR
NC State University
Frequently Asked Questions
Who can join the NCT06452186 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Lower Limb Amputation Below Knee (Injury). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06452186 currently recruiting?
Yes, NCT06452186 is actively recruiting participants. Contact the research team at nrel.ncsu.contact@gmail.com for enrollment information.
Where is the NCT06452186 trial being conducted?
This trial is being conducted at Raleigh, United States.
Who is sponsoring the NCT06452186 clinical trial?
NCT06452186 is sponsored by North Carolina State University. The principal investigator is He Huang, PhD at NC State University. The trial plans to enroll 50 participants.