At a glance
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Portable Bioimpedance Monitoring: Testing a New Diagnostic Interface
In Brief
A clinical study evaluating Bioimpedance monitor for Transtibial Amputee. Completed, enrolled 68 participants across 1 site.
Detailed Summary
The purpose of the proposed study is to conduct research on individuals with lower limb amputation, evaluating if residual limb fluid volume data collected using a novel non-invasive device is beneficial towards prosthetic prescription, fit, and comfort as determined by amputee test subjects and practitioners (prosthetists). Participants' residual limb fluid volume will be monitored through bioimpedance analysis both before and after a practitioner-issued modification to the prosthesis as an observational cohort study and then as a blinded randomized control trial in which the data may or may not be shared with the practitioner before the modification is made to the prosthesis.
Study Details
Timeline
Interventions
Participant in aim 1 will be monitored using the bioimpedance monitor. Data obtained from the arm 1 cohort will be used to inform socket modifications made for arm 2 cohort.