Acceptability of an Interim Socket System (ASSIST)

Acceptability of an Interim Socket System in the Immediate Rehabilitation of People With a tranSTibial Amputation (ASSIST): A Pilot Study

This study will explore the acceptability of an interim socket system to new patients with a below-knee amputation and also to NHS healthcare providers.

Study Overview

• Status: Active, not recruiting
• Conditions: Amputation
• Intervention / Treatment: Device: Amparo confidence socket

Detailed Description

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.

An 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.

The 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.

The 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.

Amputee 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.

Healthcare providers delivering the treatment will also be interviewed about their acceptability of the confidence socket within the NHS pathways.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • University Hospitals Dorset NHS Foundation Trust
  • Portsmouth, United Kingdom, PO3 6AD
    • Portsmouth Hospitals University NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over the age of 18
• New transtibial amputation within the last 6 months
• Deemed ready to cast for a prosthesis by the clinical team as per usual care at the prosthetic centre
• Able to understand written English and provide informed consent

Exclusion Criteria:

• Participants under the age of 18
• Participants with an ankle disarticulation, Knee disarticulation or transfemoral amputation
• Body mass > 125 kg with a distal circumference of 23-34 cm (small socket)
• Body mass > 150 kg with a distal circumference of 30-45 cm (large socket)
• Residual limb longer than 27 cm
• Severe upper limb dysfunction (due to strength requirements to don the liner)
• Severe visual requirements (that would restrict the person's ability to monitor their residual limb)
• Contraindication to be fit for a prosthetic socket
• Recent cerebrovascular event (i.e., stroke, haemorrhage, brain injury)
• Disease affecting their memory
• Unwilling to trial the confidence socket system
• Unable to tolerate wearing a prosthetic liner due to excess sweating/ allergic reaction or other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Confidence socket; Participants to receive a confidence socket system	Device: Amparo confidence socket; Confidence socket involves thermoplastic material being moulded onto the patient's residual limb and a socket is produced in a single session. The socket can be remoulded to adjust to changes in residual limb volume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Socket comfort score	Patient-reported socket comfort	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EQ-5D-5L	Health related quality of life	Up to 6 months
Change in Locomotor Capabilities Index (LCI-5)	LCI-5 with prosthesis	Up to 6 months
Change in Activities Balance Confidence-UK (ABC-UK)	Balance confidence	Up to 6 months
Change in L-test	Functional timed up and go L-test	Up to 6 months

Collaborators and Investigators

• Sponsor: University of Hull
• Collaborators: University of Southampton; Portsmouth Hospitals NHS Trust; University Hospitals Dorset NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Estimated): November 28, 2024
• Study Completion (Estimated): November 28, 2024

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: prosthesis; transtibial; socket; below-knee; residual limb
• Other Study ID Numbers: RS149-291816-NV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No