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

Don Carlo Gnocchi Onlus Foundation

Status: Enrolling

Conditions: Fall Risk; Slip Perturbations; Lower Limb Amputation

Treatments: Device: Experimental Group; Procedure: prosthetic group performs the entire protocol with their own prosthesis

Study type: Observational

Funder types: Other

Identifiers

NCT06883942

MOTU++ Studio Clinico Pedane

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

30 participants in 1 patient group

Subjects with unilateral trans-femoral and/or trans-tibial amputation.

Treatment:

Procedure: prosthetic group performs the entire protocol with their own prosthesis

Device: Experimental Group