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Bionic leg learns your moves: new prosthesis aims for natural gait

NCT ID NCT06616402

Disease control Sponsor: Fondazione Don Carlo Gnocchi Onlus Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new type of prosthetic leg for people who have lost a leg below or above the knee. The smart leg uses sensors to detect muscle signals and provides gentle vibrations to help the user feel the leg's position. It also has powered knee and ankle joints that actively assist with walking, making daily activities easier. Eight experienced prosthetic users completed the trial to check if the device was safe and worked well.

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

8 people

The number who actually took part.

Started

Nov 2023

Finished

Dec 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 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age between 18 and 80 years; * Lower limb amputation at the transfemoral or transtibial level; * Functional medical classification: Level K3-K4 \[25\]; * Subjects wearing a prosthesis for at least 1 year (experienced wearers); * Maximum body weight 100 kg. Exclusion Criteria: * Significant medical comorbidities: Presence of severe neurological disorders, cardiovascular diseases, uncontrolled diabetes/hypertension, or severe sensory deficits. * Implanted cardiac devices: Individuals with implanted pacemakers or cardioverter-defibrillators. * Cognitive impairment: Individuals with a Mini-Mental State Examination (MMSE) score less than 24, adjusted for age and education, indicating cognitive impairment that may compromise understanding of instructions and research participation. * Severe depressive symptoms: Individuals with a Beck Depression Inventory-II (BDI-II) score less than 19, indicating clinically significant depression that may affect motivation and participation in the research. * Severe anxiety symptoms: Individuals with a State-Trait Anxiety Inventory (STAI-Y) score less than 50, indicating clinically significant anxiety that may interfere with research participation. * Inability or unwillingness to provide informed consent: Individuals who are unable to understand or provide informed consent to participate in the research, or who refuse to participate.

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Conditions

The condition(s) this trial relates to.

Amputation, Traumatic injury

As listed by the trial registrant

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

Amputation Leg amputation Traumatic amputations

Contacts and locations

Locations

  • IRCCS Fondazione Don Carlo Gnocchi

    Florence, FI, 50143, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.