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| Name | Class |
|---|---|
| Biorobotic Institute Scuola Superiore sant'Anna Pisa | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with unilateral trans-femoral and/or trans-tibial amputation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prosthetic group performs the entire protocol with their own prosthesis | Procedure | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| algorithm validation | Verifying the measurement performance of the trip and slip detection algorithm on prosthesis wearers | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| data aquiring | Acquire data on amputees to be used for the development of a new version of the detection algorithm and its testing. | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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subjects with monolateral trans-femoral and/or trans-tibial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Fondazione Don Carlo Gnocchi | Florence | Italy | 50143 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21859635 | Result | 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. | |
| 35079822 | Result | 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. |
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| Experimental Group | Device | 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. |
|
| 27485674 | Result | 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. |
| 11494181 | Result | 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. |