Clinical Trial

Socket Modification in Transtibial Amputees

Study Description

Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Socket Modification Regime

Data obtained from the arm 1 cohort will be used to inform socket modifications made for arm 2 cohort.

Additional Information

Official Study Title

Portable Bioimpedance Monitoring: Testing a New Diagnostic Interface

Clinical Trial ID

NCT03164356

ParticipAid ID

7ax09a