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

Recruiting

• Conditions: Lower Limb Amputation; Slip Perturbations; Fall Risk

• Registration Number: NCT06883942
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief 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.

Study Timeline

• Study Start: 2024-02-06
• Study First Submitted: 2025-02-14
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
algorithm validation	baseline	Verifying the measurement performance of the trip and slip detection algorithm on prosthesis wearers

Secondary Outcome Measures

Name	Time	Method
data aquiring	baseline	Acquire data on amputees to be used for the development of a new version of the detection algorithm and its testing.

Trial Locations

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi; 🇮🇹 Florence, Italy