Clinical tests are progressing

Teesside University and South Tees Hospitals NHS Foundation Trust, based in Middlesbrough in the north-east of England, are pleased to state progress with the first in person clinical tests and trial to investigate the typical pressure pattern at the stump socket interface for optimal and sub-optimal above knee amputee prostheses, particularly in connection to the trial into the relationship between amputee socket pressure and perceived comfort. 

The study, which is sponsored by Teesside University, has obtained approval by Health Research Authority (HRA) and REC (Research Ethics Committee) and has also received additional support from NIHR Clinical Research Network (CRN) Portfolio.

The research team is using a commercially available pressure sensor and will investigate residual limb-socket interface pressures and their relationship with perceived levels of socket comfort in trans-femoral amputees.  The main goal of this study is to determine quantitative pressure patterns at the socket-residual limb interface in above-knee amputees during standing and walking with a ‘comfortable’ and ‘uncomfortable’ socket.  It is expected that a relationship between the objective pressure measurements in the socket and the subjective perception of comfort may then be formed.  The main research objective is to measure the pressure at the residual limb-socket interface at different areas of the trans-femoral residual limb and relate it to comfort. The trials will take place in Teesside University’s 130m2 large biomechanics laboratory, which is equipped with a 12-camera motion capture system, force plates embedded in the floor.  A team from the Teesside University Healthcare Innovation Centre with an independent prosthetist will carry out the clinical testing. Patient recruitment has started and data collection with patients is due to start in June 2021.

Work is also continuing in a larger clinical trial with tests due to take place at South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK, and the Virgen del Rocío University Hospital, Seville, Spain.  Alongside partners, we are finalising the protocol and supporting documents, with the necessary applications for regulatory authority and ethical approvals recently being submitted.  The trial is planned to start in the summer of 2021.  This trial is a multi-centre, technology validation trial to analyse the functionality of the SocketSense sensor embedded in an above-knee amputee patient’s prosthesis.   At South Tees Hospitals NHS Foundation Trust and Teesside University Healthcare Innovation Centre the research team will look at investigating the relationship of the residual limb-socket interface pressure measurements with the prototype QTSS sensing system compared to a commercially available in-socket pressure measurement system and at The Virgen del Rocío University Hospital the team will investigate the residual limb-socket interface pressure and shear measurements with the prototype QTSS sensing system.

Plans are moving forward, and we hope to be able to give further updates on the trials progression as we go forward.