Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Deviceā¦ (NCT06883942) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.
Italy8 participantsStarted 2024-02-06
Plain-language summary
The study aims to identify prognostic biomarkers of fall risk in patients with lower limb amputation
Who can participate
Age range18 Years ā 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).