Clinical trial NCT06883942: Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.
Official title: Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lower Limb Amputation
Slip Perturbations
Fall Risk
Keywords: amputation
stumble
slipping
lower limb
fall risk
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Biorobotic Institute Scuola Superiore sant'Anna Pisa
First posted: 2025-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with monolateral trans-femoral and/or trans-tibial.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: algorithm validation
timeFrame: baseline
Secondary outcomes:
measure: data aquiring
timeFrame: baseline
Other outcomes:
Locations:
city: Florence
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
Study officials:
References:
citation: Zhang F, D'Andrea SE, Nunnery MJ, Kay SM, Huang H. Towards design of a stumble detection system for artificial legs. IEEE Trans Neural Syst Rehabil Eng. 2011 Oct;19(5):567-77. doi: 10.1109/TNSRE.2011.2161888. Epub 2011 Aug 18.
citation: Palumbo P, Randi P, Moscato S, Davalli A, Chiari L. Degree of Safety Against Falls Provided by 4 Different Prosthetic Knee Types in People With Transfemoral Amputation: A Retrospective Observational Study. Phys Ther. 2022 Apr 1;102(4):pzab310. doi: 10.1093/ptj/pzab310.
citation: Hunter SW, Batchelor F, Hill KD, Hill AM, Mackintosh S, Payne M. Risk Factors for Falls in People With a Lower Limb Amputation: A Systematic Review. PM R. 2017 Feb;9(2):170-180.e1. doi: 10.1016/j.pmrj.2016.07.531. Epub 2016 Jul 30.
citation: Miller WC, Speechley M, Deathe B. The prevalence and risk factors of falling and fear of falling among lower extremity amputees. Arch Phys Med Rehabil. 2001 Aug;82(8):1031-7. doi: 10.1053/apmr.2001.24295.