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

Fondazione Don Carlo Gnocchi Onlus30 enrolled

Overview

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

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

Conditions

Lower Limb Amputation Slip Perturbations Fall Risk

Interventions

prosthetic group performs the entire protocol with their own prosthesisPROCEDURE

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.

Experimental GroupDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi

Florence, Italy

RECRUITING

Outcomes

Primary Outcomes

algorithm validation

Verifying the measurement performance of the trip and slip detection algorithm on prosthesis wearers

Time frame: baseline

Secondary Outcomes

data aquiring

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

Time frame: baseline

Central Contacts

Claudio Macchi, MD

CONTACT

+39 0557393909 cmacchi@dongnocchi.it

Data from ClinicalTrials.gov

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