Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.
NCT ID: NCT06883942
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-02-06
2025-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Subjects with unilateral trans-femoral and/or trans-tibial amputation.
prosthetic group performs the entire protocol with their own prosthesis
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 Group
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.
Interventions
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prosthetic group performs the entire protocol with their own prosthesis
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 Group
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 Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
80 Years
ALL
Yes
Sponsors
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Biorobotic Institute Scuola Superiore sant'Anna Pisa
UNKNOWN
Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Locations
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IRCCS Fondazione Don Carlo Gnocchi
Florence, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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MOTU++ Studio Clinico Pedane
Identifier Type: -
Identifier Source: org_study_id
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