Design and validation of novel prosthetic socket using MRI data V1
Research type
Research Study
Full title
Design and validation of novel socket concept and synthetic residual limb replica using MRI data
IRAS ID
327893
Contact name
Thomas Arnstein
Contact email
Sponsor organisation
University of Strathclyde
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The objective of this research project is to design, validate, and perform user testing of a novel transtibial prosthetic socket. Prosthetic sockets form the connection between the residual limb and prosthetic device. Residual limb discomfort and injury, caused by force transmitted via the prosthetic socket, is commonly experience by people living with amputation. This can lead to reduced device use and device rejection, severely impacting on users' ability to complete activities of daily living. With prosthetic socket comfort consistently highlighted by users as an area requiring improvement, further research into socket design is warranted.
The novel socket in this study aims to more uniformly load the residual limb than currently clinically utilised designs, therefore reducing mechanical stresses within the soft tissues and minimising the danger to users. The novel socket utilises a fluid filled chamber and elastomeric interface to facilitate improved load redistribution.
This study seeks to recruit three people with transtibial amputation who are regular prostheses users and who do not suffer from chronic residual limb complications. MRI scans will be taken of each user’s residual limb; wearing no socket and while wearing two clinically utilised designs. The MRI scans will be used to manufacture a synthetic replica of each residual limb, and to manufacture the novel socket. The synthetic replica will allow benchtop testing, including ensuring the socket meets appropriate elements of ISO-22675:2016, before undergoing user testing. The novel socket will then be tested against two clinically utilised designs using a range of outcome measures including pressure distribution, user feedback, and a further set of MRI scans to investigate soft tissue deformation. The study duration will be 24 months. MRI Scans will be taken at the Golden Jubilee University National Hospital. The rest of the study will be conducted at the department for biomedical engineering, University of Strathclyde.
REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0058
Date of REC Opinion
3 Jul 2023
REC opinion
Favourable Opinion