NCT06883942

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Lower Limb Amputation
• Slip Perturbations
• Fall Risk

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-06
• Primary completion: 2025-07-17
• Completion: 2025-07-17
• First posted: 2025-03-19
• Last updated: 2026-03-27

Locations

1 site across 1 country: Italy