Acceptability of an Interim Socket System

NCT05196100 | Active Not Recruiting

• 1 other identifier: RS149-291816-NV
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Amputation

Keywords

transtibial; below-knee; prosthesis; socket; residual limb

Outcome Measures

Primary Outcomes (1)

• Change in Socket comfort score

  Patient-reported socket comfort

  Up to 6 months

Secondary Outcomes (4)

• Change in EQ-5D-5L

  Up to 6 months

• Change in Locomotor Capabilities Index (LCI-5)

  Up to 6 months

• Change in Activities Balance Confidence-UK (ABC-UK)

  Up to 6 months

• Change in L-test

  Up to 6 months

Study Arms (1)

Confidence socket

EXPERIMENTAL

Participants to receive a confidence socket system

Device: Amparo confidence socket

Interventions

Amparo confidence socket DEVICE

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.

Confidence socket

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hull: lead
• Portsmouth Hospitals NHS Trust: collaborator
• University Hospitals Dorset NHS Foundation Trust: collaborator
• University of Southampton: collaborator

Study Sites (2)

University Hospitals Dorset NHS Foundation Trust

Bournemouth, BH7 7DW, United Kingdom

Location

Portsmouth Hospitals University NHS Trust

Portsmouth, PO3 6AD, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 19, 2022
• Study Start: October 12, 2021
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)