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Bionic breakthrough: new surgery lets amputees 'Feel' their prosthetic foot

NCT ID NCT03913273

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed trial tested a new surgical procedure called an agonist-antagonist myoneural interface (AMI) in 14 people with below-knee amputations. The surgery connects muscle pairs in the residual limb to allow better communication with a bionic prosthetic. The goal was to improve control and provide a sense of joint position and movement, making the prosthetic feel more like a natural limb.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Agonist-antagonist myoneural interface (AMI) surgical procedure
What this could lead to
If successful, this could lead to bionic legs that feel more natural and are easier to control, improving mobility and quality of life for people with below-knee amputations.
What could go wrong
This was a small, early-stage trial with only 14 participants. The results may not apply to all amputees, and the procedure requires specialized surgery. Long-term benefits and risks are still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Started

Jun 2019

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Massachusetts Institute of Technology

    Cambridge, Massachusetts, 02139, United States

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