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NCT03913273 · ClinicalTrials.gov registry record · NA
Agonist-Antagonist Myoneural Interface for Functional Limb Restoration After Transtibial Amputation
A NA study, sponsored by Massachusetts Institute of Technology.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT03913273: Completed NA study, sponsored by Massachusetts Institute of Technology.
NCT03913273 is a NA study that has completed, run by Massachusetts Institute of Technology. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03913273, a NA study, has completed, sponsored by Massachusetts Institute of Technology.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The stability of joint position control in free space is quantified by the number of the distinct synergy activations (distinct movements) achieved out of a total of four targeted movements of interest: (1) ankle plantar flexion (toe down), (2) dorsiflexion (toe up), (3) subtalar joint eversion (sole of foot outward), and (4) subtalar joint inversion (sole of foot inward). For each movement, the subject is asked attempt the movement while the distinct synergy activation/neural signals are quanti
Interventions
- PROCEDURE AMI transtibial amputation
- PROCEDURE Standard transtibial amputation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2025-06-01 |
| Phase | NA |
What the finished NCT03913273 record still lists
NCT03913273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which AMI transtibial amputation is the first listed.
NCT03913273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03913273 about?
NCT03913273 is a clinical study titled "Agonist-Antagonist Myoneural Interface for Functional Limb Restoration After Transtibial Amputation". 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 (AMI...
What is the current status of trial NCT03913273?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2019-06-12. Estimated completion is 2025-06-01.
What interventions are being tested in trial NCT03913273?
The interventions under investigation include: AMI transtibial amputation (PROCEDURE), Standard transtibial amputation (PROCEDURE).
Who is sponsoring clinical trial NCT03913273?
This trial is sponsored by Massachusetts Institute of Technology, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03913273's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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