Fall Risk, Lower Limb Amputation, Slip Perturbations
Conditions
Keywords
amputation, stumble, slipping, lower limb, fall risk
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.
Interventions
PROCEDUREprosthetic 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.
DEVICEExperimental 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.
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Biorobotic Institute Scuola Superiore sant'Anna Pisa
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| algorithm validation | baseline | Verifying the measurement performance of the trip and slip detection algorithm on prosthesis wearers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| data aquiring | baseline | Acquire data on amputees to be used for the development of a new version of the detection algorithm and its testing. |
Countries
Italy
Outcome results
None listed