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

Last updated: March 17, 2025
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

prosthetic group performs the entire protocol with their own prosthesis

Experimental Group

Clinical Study ID

NCT06883942
MOTU++ Studio Clinico Pedane
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Significant medical comorbidities (severe neurological disease, cardiovasculardisease 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

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: prosthetic group performs the entire protocol with their own prosthesis
Phase:
Study Start date:
February 06, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • IRCCS Fondazione Don Carlo Gnocchi

    Florence, 50143
    Italy

    Active - Recruiting

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