ASSIST: Acceptability of an interim socket system
Research type
Research Study
Full title
Acceptability of an interim Socket System in the Immediate rehabilitation of people with a tranSTibial amputation (ASSIST): A pilot study
IRAS ID
291816
Contact name
Natalie Vanicek
Contact email
Sponsor organisation
University of Hull
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 28 days
Research summary
After a transtibial amputation, post-operative swelling, followed by muscle wasting, can lead to residual limb volume changes during the first 12 months. Managing this volume change often involves many socket modifications and/or replacement sockets. These multiple re-casts can be burdensome for the patient and delay recovery as patients are unable to mobilise and progress in an ill-fitting socket, leading to increased health resource use and costs. \n\nAn alternative technology exists involving an interim (aka confidence) socket whereby thermoplastic material is moulded onto the patient’s residual limb and a socket is produced in a single session. This material can then be heated and remoulded quickly and comfortably, so that the patient accommodates to a single socket that can be adjusted as required to volume changes. \n\nThe confidence socket system could make the casting and prosthetic fitting process more efficient and cost-effective and improve the speed of delivery of the interim prosthesis. Thus a patient could start gait re-training with their confidence socket earlier compared to the standard treatment of fitting a laminate or polypropylene socket.\n\nThe aim of this pilot study is to assess the acceptability of the confidence socket to NHS healthcare providers and their patients, during an initial 3-month prosthetic fitting period.\n\nAmputee participants will be recruited from 2 NHS sites. They will receive standard pre-prosthetic physiotherapy treatment until their primary MDT appointment, when they will be cast for their first prosthesis using the confidence socket which will replace standard care with the usual socket. Prescription of prosthetic foot components will continue as per usual care. Once the confidence socket is complete the patient will begin treatment according to usual physiotherapy rehabilitation. Amputee participants will be interviewed about their experience of receiving treatment with the confidence socket. \n\nHealthcare providers delivering the treatment will also be interviewed about their acceptability of the confidence socket within the NHS pathways.\n\n
REC name
South Central - Oxford B Research Ethics Committee
REC reference
21/SC/0228
Date of REC Opinion
2 Sep 2021
REC opinion
Further Information Favourable Opinion