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New device aims to predict falls in amputees

NCT ID NCT06883942

Knowledge-focused Sponsor: Fondazione Don Carlo Gnocchi Onlus Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tested a new device designed to detect slips and trips in people with lower-limb amputations. Eight experienced prosthesis users walked on special platforms that simulate slipping or tripping. The goal was to see if the device could reliably detect these events and help identify who is at higher risk of falling.

What this could mean

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

What this could lead to
If successful, this could lead to better ways to predict and prevent falls in people with leg amputations.
What could go wrong
This is a very small pilot study with only 8 participants, so results may not apply to everyone. The device is still being tested for reliability.

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.

Participants

8 people

The number who actually took part.

Started

Feb 2024

Finished

Jul 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.

Who is studied

subjects with monolateral trans-femoral and/or trans-tibial.

Ages

18 to 80 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: * Trans-femoral or trans-tibial lower limb amputation; * Functional medical classification: Level K3-K4; * Subjects who have had a prosthesis for at least 1 year (experienced wearers); * Informed consent signed by the subject Exclusion Criteria: * Significant medical comorbidities (severe neurological disease, cardiovascular disease diabetes/unstabilised hypertension, severe sensory deficits); * Cardiac device wearers (PMK or AICD); * Cognitive impairment (MMSE adjusted for age and schooling \<24); * Inability or unwillingness to provide informed consent; * Severe depressive symptomatology - Beck Depression Inventory (BDI-II \<19); * Severe anxiety symptoms - State-Trait Anxiety Inventory (STAI-Y \<50).

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As listed by the trial registrant

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

Fall risk Lower limb amputation Slip perturbations

Contacts and locations

Locations

  • IRCCS Fondazione Don Carlo Gnocchi

    Florence, Italy, 50143, Italy

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