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Restoration of Normative Postural Control

NCT06452186 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-13

No results posted yet for this study

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)

Interventions

DEVICE

direct EMG controlled prosthetic ankle

Patients are trained to use the powered prosthetic ankles

BEHAVIORAL

PT guided prosthetic training

Amputees are trained to use prosthetic ankles

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • North Carolina State University

    lead OTHER

Principal Investigators

  • He Huang, PhD · NC State University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2027-07-01
Completion
2028-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06452186 on ClinicalTrials.gov