Restoration of Normative Postural Control

NCT06452186 | Recruiting FDA Device

• 1 other identifier: 26076
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.whether dEMG control will improve balance and postural stability of amputees,
2. 2.whether dEMG control will lead to more natural neuromuscular control and coordination, 3) whether dEMG control will reduce cognitive processes.

Conditions

Lower Limb Amputation Below Knee (Injury)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• aCOM, anticipatory Center of Mass Excursion when the expected disturbance is introduced

  This measurement is to quantify the movement of the COM at the time when the disturbance is introduced and represents an important element of the capability of the participants to conduct anticipatory. Higher value indicates better capacity to conduct anticipatory postural control.

  Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices

Secondary Outcomes (6)

• Frequency of stepping responses

  Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices

• Zero-time-lag cross correlation coefficients for bilateral ankle torque

  Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices

• Prosthesis Embodiment Scale

  Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices

• Average muscle modules structure correlation

  Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices

• Scores from Amputee Mobility Predictor (AMP) Test

  Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices

Study Arms (2)

dEMG group

EXPERIMENTAL

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

Device: direct EMG controlled prosthetic ankle; Behavioral: PT guided prosthetic training

Passive group

ACTIVE COMPARATOR

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

Behavioral: PT guided prosthetic training

Interventions

direct EMG controlled prosthetic ankle DEVICE

Patients are trained to use the powered prosthetic ankles

dEMG group

PT guided prosthetic training BEHAVIORAL

Amputees are trained to use prosthetic ankles

Passive group; dEMG group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Carolina State University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

North Carolina State University

Raleigh, North Carolina, 27695, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• He Huang, PhD

  NC State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neuromuscular Rehabilitation Engineering Laboratory

CONTACT

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

Ming Liu, PhD

CONTACT

919-515-8543; mliu10@ncsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The PT, who evaluates the participants, is blinded for their previous training experience.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two groups amputees go through the same training procedure with different prostheses. Their functionality will be compared before and the after the training.

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: June 11, 2024
• Study Start: October 1, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)