RECRUITING

Agonist-Antagonist Myoneural Interface for Functional Limb Restoration After Transtibial Amputation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study involves the functional testing of a new lower extremity prosthesis by healthy, active participants with fully healed transtibial (below knee) amputations. The study design calls for an experimental group of eleven participants who received two agonist-antagonist myoneural interfaces (AMIs) that were surgically constructed during a modified transtibial amputation procedure, and a control group of eleven matched participants who received standard transtibial amputations. The study protocol involves one or more of the following activities: 1. Collection of electromyography (EMG) data from participants' lower limbs to characterize muscle activation and create maps specific to individual participants, 2. Investigation of participants' capabilities to use a new lower extremity prosthesis that is designed to allow independent actuation of the ankle and subtalar joints, and offers EMG-modulated control over prosthetic joint position and stiffness, and 3. Exploration of AMIs as a means of communicating information between the participant and the new prosthesis using an experimental system involving EMG, functional electrical stimulation, and ultrasound. The hypothesis is that transtibial amputations involving AMIs can offer improved motor control of the new prosthesis while also enabling proprioceptive sensation (perception of the position, movement, and torque of the affected limb and prosthetic joint). The AMIs are expected to improve voluntary prosthetic control, improve prosthetic terrain adaptations, and offer new possibilities for bi-directional communication across the human-device interface.

Official Title

Agonist-Antagonist Myoneural Interface for Functional Limb Restoration After Transtibial Amputation

Quick Facts

Study Start:2019-06-12
Study Completion:2024-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03913273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Modified transtibial (below knee) amputation incorporating agonist-antagonist myoneural interfaces (AMIs) and performed at the Brigham and Women's Hospital, Boston, MA.
  2. * Fully healed amputation site
  3. * Proficiency in using a standard lower extremity prosthesis
  4. * Activity or K-Level of at least K3 to K4 (capability to ambulate with variable cadence)
  5. * Standard transtibial (below knee) amputation
  6. * Fully healed amputation site
  7. * Proficiency in using a standard lower extremity prosthesis
  8. * Activity or K-Level of at least K3 to K4 (capability to ambulate with variable cadence)
  9. * Persons beyond the stated age restrictions
  10. * Persons with one or more of the following underlying health conditions: cardiopulmonary instability manifest as coronary artery disease, chronic obstructive pulmonary disease, and extensive microvascular compromise
  11. * Persons who are active smokers
  12. * Persons who are pregnant
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Hugh M Herr, PhD
CONTACT
617-253-6780
HHerr@media.mit.edu
Maria D Ramos Garcia, PhD
CONTACT
617-452-5633
MariaRG@mit.edu

Principal Investigator

Hugh M Herr, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts Institute of Technology

Study Locations (Sites)

Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
United States

Collaborators and Investigators

Sponsor: Massachusetts Institute of Technology

  • Hugh M Herr, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Institute of Technology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-12
Study Completion Date2024-02

Study Record Updates

Study Start Date2019-06-12
Study Completion Date2024-02

Terms related to this study

Keywords Provided by Researchers

  • Proprioception
  • Movement
  • Joint Prosthesis
  • Feedback
  • Rehabilitation

Additional Relevant MeSH Terms

  • Amputation