New prosthetic technology for below-knee amputees
Agonist-Antagonist Myoneural Interface for Functional Limb Restoration After Transtibial Amputation
This study is testing a new type of prosthetic leg for people with below-knee amputations to see if it helps them move better and feel more in control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts Institute of Technology Academic / other |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT03913273 on ClinicalTrials.gov |
What this trial studies
This study tests a novel lower extremity prosthesis designed for individuals with transtibial amputations. Participants will be divided into two groups: one receiving a modified amputation with agonist-antagonist myoneural interfaces (AMIs) and the other receiving a standard transtibial amputation. The study will collect electromyography (EMG) data to assess muscle activation and evaluate the functionality of the new prosthesis, which allows for independent control of ankle and subtalar joints. The goal is to improve communication between the user and the prosthetic device, enhancing mobility and quality of life.
Who should consider this trial
Good fit: Ideal candidates are individuals with fully healed transtibial amputations who are proficient in using a standard prosthesis and have a K-Level of at least K3 to K4.
Not a fit: Patients with underlying health conditions such as cardiopulmonary instability or those who do not meet the activity level criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly improve mobility and independence for below-knee amputees.
How similar studies have performed: Previous studies have shown promise in similar approaches, but this specific method of using AMIs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Experimental group participants: * Modified transtibial (below knee) amputation incorporating agonist-antagonist myoneural interfaces (AMIs) and performed at the Brigham and Women's Hospital, Boston, MA. * Fully healed amputation site * Proficiency in using a standard lower extremity prosthesis * Activity or K-Level of at least K3 to K4 (capability to ambulate with variable cadence) Control group participants: * Standard transtibial (below knee) amputation * Fully healed amputation site * Proficiency in using a standard lower extremity prosthesis * Activity or K-Level of at least K3 to K4 (capability to ambulate with variable cadence) Exclusion Criteria Experimental and Control group participants: * Persons beyond the stated age restrictions * 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 * Persons who are active smokers * Persons who are pregnant
Where this trial is running
Cambridge, Massachusetts
- Massachusetts Institute of Technology — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Hugh M Herr, PhD — Massachusetts Institute of Technology
- Study coordinator: Hugh M Herr, PhD
- Email: HHerr@media.mit.edu
- Phone: 617-253-6780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.