Telemetric Sensing in Lower Limb Prostheses
Research type
Research Study
Full title
Non-Invasive Telemetric Sensing in Lower Limb Prostheses to assist surface skin management in lower limb amputees.
IRAS ID
254126
Contact name
Lorraine Graham
Contact email
Sponsor organisation
Bioflex Ltd
Duration of Study in the UK
0 years, 3 months, 3 days
Research summary
For lower limb amputees, use of a lower limb prosthesis can achieve acceptable mobility, maintain employment and improve quality of life. However, use of the prosthesis is associated with a high incidence of skin inflammation, potentially leading to ulceration, infection and cessation of use. Amputees with diabetes have a particular increased risk, complicated by the loss of pain sensation.
Within the socket of the prosthesis, increased temperature, rising levels of moisture and continuing interface pressure and shear stress are associated with an increased incidence of skin breakdown. Measurement of these factors can potentially be used as an early-warning sign of impending tissue damage, and if communicated in an appropriate fashion, can alert the amputee to intervene in a timely manner to prevent progression to skin damage.
This proof-of-concept study proposes to build a sensor capsule into the standard liner within the prosthetic socket. The sensor, developed by a group headed by Bioflex Yarns Ltd, will continuously measure temperature, humidity and movement within the socket, and communicate this information to a mobile phone app held by the amputee (or carer). Further communication will be to an pseudonymised cloud-based platform for data analysis , and reflected back to a dashboard report for the relevant clinical team based within the Amputee Rehabilitation Centre.
The purpose of the study is to determine the functionality of the sensor capsule in normal prosthetic use, to assess the communication systems to app and cloud, and to assess patient acceptability of the system. In total, twenty patients who are already using an appropriate lower limb prosthesis will be recruited through the Regional Disablement Service. The sensor capsule will be fitted in the base of the socket and data collected over a four week period, in the first instance. The funding sponsor will be Bioflex Yarns Ltd.REC name
HSC REC B
REC reference
19/NI/0147
Date of REC Opinion
29 Aug 2019
REC opinion
Further Information Favourable Opinion