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Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.

NCT06883942 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2026-03-27

No results posted yet for this study

Summary

The study aims to identify prognostic biomarkers of fall risk in patients with lower limb amputation

Conditions

  • Lower Limb Amputation
  • Slip Perturbations
  • Fall Risk

Interventions

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.

Sponsors & Collaborators

  • Biorobotic Institute Scuola Superiore sant'Anna Pisa

    collaborator UNKNOWN

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-06
Primary Completion
2025-07-17
Completion
2025-07-17

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06883942 on ClinicalTrials.gov