Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs. (MOTU++ pedane)

March 26, 2026 updated by: Fondazione Don Carlo Gnocchi Onlus
The study aims to identify prognostic biomarkers of fall risk in patients with lower limb amputation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The protocol will involve both trans-tibial and trans-femoral amputation subjects, for a total duration of up to 5 sessions.

Initially, the fall detection algorithm will be evaluated on trans-femoral and trans-tibial amputees performing the test while wearing their prosthesis.

In a second step, the experimentally obtained prognostic markers of fall risk will be studied (i.e., using one or both of the perturbation platforms described below).

The markers thus obtained are to be validated by comparison with markers already established in clinical practice or in the literature.

Experimental platforms The platforms are composed of a mechanism to simulate and investigate the aid that the prosthetic system can provide in the event of a source of tripping and/or slipping.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy
      • Florence, Italy, Italy, 50143
        • IRCCS Fondazione Don Carlo Gnocchi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with unilateral trans-femoral and/or trans-tibial amputation.
Procedure: prosthetic group performs the entire protocol with their own prosthesis

The 1st session is the enrolment and functional evaluation one. The following 2 we test the algorithm functionality verification; one session for both platforms. The last 2 sessions are necessary to acquire prognostic markers for falls; one session for both platforms.

The balance disturbance tests will take place on two platforms:

  • The sliding platform consists of a metal supporting structure and a wooden cover, which has a manual release mechanism that allows the activation of the tile responsible for simulating the events that occur during sliding.
  • The stumbling platform consists of a metal supporting structure and a wooden cover, which features an electronically activated plastic and foam tripping mechanism that simulates the sequence of events that occur during a stumble.
Device: Experimental Group
The fall detection algorithm will be evaluated first. In a second step, the experimentally obtained prognostic markers of fall risk will be studied. The markers thus obtained shall be validated by comparison with markers already established in clinical practice or in the literature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
algorithm validation
Time Frame: baseline
Verifying the measurement performance of the trip and slip detection algorithm on prosthesis wearers
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
data aquiring
Time Frame: baseline
Acquire data on amputees to be used for the development of a new version of the detection algorithm and its testing.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

Biorobotic Institute Scuola Superiore sant'Anna Pisa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2024

Primary Completion (Actual)

July 17, 2025

Study Completion (Actual)

July 17, 2025

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MOTU++ Studio Clinico Pedane

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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