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Search / Trial NCT06371209

Kinematics of Ewing Amputees

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Apr 12, 2024

Trial Information

Current as of November 11, 2025

Enrolling by invitation

Keywords

Amputation Kinematics Gait

ClinConnect Summary

This is an observational study that looks at how people walk after a trans-tibial (below-knee) amputation, comparing those who had a special nerve-muscle reconstruction called an agonist-antagonist myoneural interface (AMI, used in the Ewing Amputation) with people who had a standard amputation. Researchers will measure muscle activity and walking patterns using EMG and motion capture in a single 2.5-hour visit to a Boston lab. The main questions are whether the remaining leg muscles and movement in AMI users mirror their intact leg more closely, and whether their walking patterns are more natural than those in standard amputees. About 16 AMI cases and up to 16 standard-amputation controls are planned, and the study does not involve giving a treatment.

Eligibility is limited to adults aged 18–65 with a unilateral lower limb amputation that is at least 12 months old and who wear a working prosthesis most days. Participants must have a well-fitting, stable prosthetic socket and recent prosthetist follow-up, and be able to walk independently without help. Exclusions include other conditions that affect gait or any inability to ambulate safely with or without an assistive device. During the visit, researchers will collect basic health and prosthetic history, perform physical and gait tests, place EMG sensors and motion markers, and may video-record the walking task. Data are for research purposes only, with no plan to share individual participant data.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Unilateral lower extremity amputees
  • Greater than 12 months post-amputation procedure
  • Possession and use of a working prosthesis as determined by subject's ability to wear it for 8 hours daily
  • A stable, well-fitting socket as indicated by no prosthetic modifications within the prior 14 days and no plans to modify it within the following 30 days
  • Follow-up visit with their prosthetist within the past 3 months
  • The ability to walk independently without an assistive device
  • The ability to follow directions and communicate pain or discomfort
  • Exclusion Criteria:
  • Patients beyond the stated age restrictions will be excluded
  • Patients who have any underlying neurologic, orthopedic, or cardiopulmonary impairment that affects their gait as assessed by the study clinician.
  • Patients with any medical or functional limitations preventing them from ambulating safely and independently without an assistive device.
  • Patients will be excluded who do not have a prosthesis

About Brigham And Women's Hospital

Brigham and Women's Hospital (BWH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As an integral part of the Partners HealthCare system, BWH combines cutting-edge medical education with a focus on patient-centered care, fostering an environment that promotes groundbreaking clinical trials across various specialties. The hospital is dedicated to translating scientific discoveries into effective treatments, making significant contributions to the fields of cardiovascular medicine, oncology, and women's health, among others. With a robust infrastructure for research and a collaborative approach, BWH aims to improve patient outcomes and enhance the overall quality of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Matthew Carty, MD

Principal Investigator

Brigham and Women's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported