Recruiting

Postural Control

Sponsor:

North Carolina State University

Code:

NCT06452186

Conditions

Lower Limb Amputation Below Knee (Injury)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

direct EMG controlled prosthetic ankle

PT guided prosthetic training

Study Details

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.

Conditions

Lower Limb Amputation Below Knee (Injury)

Study ID

NCT06452186

Start date

Oct 1, 2023

Status verified date

Jul, 2026

Completion date

Jul 30, 2028

Anticipated

Primary completion date

May 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: dEMG group

Patients go through the training procedure with the direct EMG controlled powered prosthetic ankle.

active comparator: Passive group

Patients go through the training procedure with their own passive prosthetic ankles

Interventions

direct EMG controlled prosthetic ankle

Patients are trained to use the powered prosthetic ankles

PT guided prosthetic training

Amputees are trained to use prosthetic ankles

Primary outcome measure

  • aCOM, anticipatory Center of Mass Excursion when the expected disturbance is introduced [ Time Frame: Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices ]

Central Contacts and Locations

Central contacts

Neuromuscular Rehabilitation Engineering Laboratory

919-513-3840nrel.ncsu.contact@gmail.com

Ming Liu, PhD

919-515-8543mliu10@ncsu.edu

Locations

North Carolina State University

Recruiting

Raleigh, North Carolina, United States, 27695

Contacts

He Huang, PhD

919-515-5218hhuang11@ncsu.edu

Laura Rohrbaugh

919-513-3840lasmith6@ncsu.edu

More Information

Sponsor

North Carolina State University

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • powered ankle prosthesis
  • direct EMG control
  • balance
  • cognitive load
  • muscle synergy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Carolina State University on 2026-07-14.