Feasibility Study on Using Smart Templates, That Link Rectification Approaches to Particular Patient Characteristics, for Transtibial Prosthetic Socket Fitting

NCT06597266 | Completed

• 2 other identifiers: IRAS 313408 / HRA REC 22/YH/0210014827
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

Prosthetic socket comfort and fit is important in ensuring individuals with amputation can get the most use from their prosthetic limb. Researchers from the University of Southampton and a spin out company Radii Devices Ltd have been developing software based upon the cutting-edge of engineering design to support clinicians in the design of the socket. The technology uses data from previous socket designs and limb shapes to develop and train the software, developed working with Opcare Ltd, a prosthetics provider. The software suggests appropriate socket design shapes (templates) that may be optimal based on previous designs and whether they have fit and been comfortable. The aim of this study is to assess the feasibility of sockets designed by the Radii Devices software, and a preliminary comparison against socket designed by a clinician (known as a prosthetist). Combining qualitative (semi-structured interview) and quantitative (Socket Comfort) methods, will enable understanding of the strengths and limitations and inform further development of the Radii Devices technology into full design software for prosthetists that provides optimal socket design support. This study is funded by an Innovate UK Biomedical Catalyst grant and will be carried out over a 6 month period at Oxford, Roehampton and Bristol Opcare NHS prosthetic services. Prosthetists at these services and patients with a below-knee amputation will be eligible to apply if they are interested. Participation will be split into two stages. In Stage One participants will be asked to trial two sockets (designed using different methods) at their fitting appointment instead of the usual one. If participants would like to participate in the second stage they will be asked about their experiences of socket fit and comfort in interviews, and within a short socket comfort diary for patients.

Conditions

Transtibial Amputation; Prosthetic

Keywords

transtibial; CAD/CAM; design; prosthetic limb

Outcome Measures

Primary Outcomes (1)

• Semi-structured interview

  To assess the feasibility of the smart templates device, by capturing participants' views and experiences of in-clinic fitting of two sockets designed in different ways, and general usability of their new prosthetic socket. The interview will be of approximately 30 minutes duration and administered immediately after the prosthetic socket fitting session (i.e. provision of the intervention) by the researcher, and optionally again one month later at a face-to-face meeting, telephone or video call

  30 minutes beginning immediately after device provision (socket fitting session), and optionally again one month after the fitting session.

Secondary Outcomes (1)

• Socket Comfort Score (SCS)

  30 minutes, i.e. at the end of the intervention provision (socket fitting session), and optionally daily over the subsequent one month

Study Arms (2)

Experimental (evidence-generated socket) then Active Comparator (control socket)

EXPERIMENTAL

Participants are first fitted with an evidence-generated prosthetic check socket (experimental), and then fitted with a prosthetist-led prosthetic check socket (active comparator)

Device: Smart template - designed prosthetic check socket; Device: Clinician-designed prosthetic check socket

Active Comparator (control socket) then Experimental (evidence-generated socket)

EXPERIMENTAL

Participants are first fitted with a prosthetist-led prosthetic check socket (active comparator), and then fitted with an evidence-generated prosthetic check socket (experimental)

Device: Smart template - designed prosthetic check socket; Device: Clinician-designed prosthetic check socket

Interventions

Smart template - designed prosthetic check socket DEVICE

Evidence-generated trial prosthetic sockets are designed automatically by performing machine learning analysis of past socket designs that were produced by expert clinicians, the participant's residual limb size and shape descriptors and patient descriptors

Active Comparator (control socket) then Experimental (evidence-generated socket); Experimental (evidence-generated socket) then Active Comparator (control socket)

Clinician-designed prosthetic check socket DEVICE

Active comparator prosthetic sockets are designed by expert prosthetists, bespoke to the participant, in a computer aided design environment (CAD)

Active Comparator (control socket) then Experimental (evidence-generated socket); Experimental (evidence-generated socket) then Active Comparator (control socket)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or over
• Attend the Bristol, Oxford or Roehampton NHS Opcare prosthetic services
• Have had a transtibial amputation
• Deemed ready to cast for a new prosthesis by the clinical team as per usual care at the prosthetic centre
• Able to understand verbal and written English and provide informed consent

You may not qualify if:

• under the age of 18
• Have had an ankle disarticulation, Knee disarticulation or transfemoral amputation
• Contraindication to be fit for a prosthetic socket
• Unwilling to trial or unable to tolerate trialling two sockets at a fitting session
• Unable to answer verbal questions (as per normal fitting appointment) on their socket fitting and comfort

Sponsors & Collaborators

• University of Southampton: lead
• Radii Devices Ltd: collaborator
• Opcare Ltd: collaborator

Study Sites (3)

Bristol Centre for Enablement

Bristol, United Kingdom

Location

Oxford Centre for Enablement

Oxford, United Kingdom

Location

Douglas Bader Rehabilitation Centre, Queen Mary's Hospital

Roehampton, United Kingdom

Location

Related Publications (2)

• A Comparison between Evidence-Generated Transtibial Sockets and Conventional CADCAM Designs, from the Patient's Perspective Florence Mbithi Dr, Maggie Donovan-Hall Prof, Jennifer Bramley Dr, Joshua Steer Dr, Charalambos Rossides Dr, Peter Worsley Prof, Chantel Ostler Dr, Cheryl Metcalf Prof, Dominic Hannett, Caroline Ward, Jack Kitchen, Sioned Steventon, Katy McIntosh, Shigong Guo Dr, Helen Harvey, David Henderson Slater Dr, Vijay Kolli Dr, Alex Dickinson Prof medRxiv 2024.09.17.24312762; doi: https://doi.org/10.1101/2024.09.17.24312762

  BACKGROUND

• Dickinson AS, Steer JW, Rossides C, Diment LE, Mbithi FM, Bramley JL, Hannett D, Blinova J, Tankard Z, Worsley PR. Insights into the spectrum of transtibial prosthetic socket design from expert clinicians and their digital records. Front Rehabil Sci. 2024 Jul 12;5:1354069. doi: 10.3389/fresc.2024.1354069. eCollection 2024.

  PMID: 39071770 BACKGROUND

Study Officials

• Alexander Dickinson, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Prosthetic sockets compared between the two arms are visually identical except for the fine details of their shape (i.e. the design) and participants will not be informed which is which, at the point of assessment.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biomechanical Engineering

Model Details: Study using mixed quantitative/qualitative methodology of quantitative outcome assessment and qualitative semi-structured interviews. A slightly larger than usual number of participants is used based on a power calculation for preliminary assessment of a secondary outcome measure, Socket Comfort Score.

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: October 17, 2022
• Primary Completion: November 14, 2023
• Study Completion: November 30, 2023
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)