Low Cost Socket for Lower Limb Amputees

NCT04725461 | Completed

• 1 other identifier: STU00207623
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to test an investigational fabrication system for transtibial prostheses. This fabrication method will be tested for comfort and function to determine feasibility of use for amputees in developing countries. To address the need for high quality and affordable prosthetic technology in developing countries, the investigators have developed a simplified socket fitting protocol using expandable rigid foam. The foam is formed by mixing small amounts of two liquid components, which typically expands to several times its original volume.

Conditions

Amputation; Amputation; Traumatic, Limb; Amputation, Traumatic

Outcome Measures

Primary Outcomes (2)

• Socket Comfort Score with Experimental Low Cost Socket

  The Socket Comfort Score will be used with the experimental low cost socket. This measure allows the subject to subjectively rate how comfortable they perceive their socket on a scale of 1 to 10, and will be administered pre and post physical outcome measures

  Day 2

• Socket Comfort Score with Clinically Prescribed Socket

  The Socket Comfort Score will be used with the subjects clinically prescribed prosthetic system. This measure allows the subject to subjectively rate how comfortable they perceive their socket on a scale of 1 to 10, and will be administered pre and post physical outcome measures

  Day 2

Secondary Outcomes (4)

• Four Square Step Test

  Day 2

• L-Test of Functional Mobility

  Day 2

• 2 Minute Walk Test

  Day 2

• Amputee Mobility Predictor

  Day 2

Study Arms (1)

Low cost lower limb socket testing

EXPERIMENTAL

Fabrication and testing of a low cost lower limb prosthetic socket and ensure this socket has appropriate suspension, comfort and f unction for a transtibial amputee.

Device: Low cost lower limb prosthetic socket

Interventions

Low cost lower limb prosthetic socket DEVICE

A pre-made 3D printed cylinder used as an outer shell is selected for each subject based on their measurements. The space between the residual limb and the outer shell will be filled with an expanding polyurethane foam (Foam IT 8, Smooth On Inc.) that conforms to the residual limb and bonds with the outer shell to form a strong and lightweight socket. The foam forms a smooth surface against the protective sheath; the socket is fully formed once the foam has hardened to the 3D printed cylinder. A prefabricated supracondylar suspension cuff made of Dacron or nylon, or a commercially available suspension sleeve may be will be applied to the prosthetic socket to aid in suspension. Commercially available components, including the International Committee of the Red Cross (ICRC) transtibial polypropylene component system will be attached to the bottom of the socket to allow the patient to ambulate in the prosthesis.

Low cost lower limb socket testing

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral transtibial amputees having had their amputation at least 6 months prior, so that they have a relatively stable conical residual limb shape and can ambulate independently
• Currently has a well-fitting prosthesis- as defined by a self-reported Socket Comfort Score of at least a 6 out of 10
• K2, K3, K4 level ambulators
• Understands the English language

You may not qualify if:

• Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate usable, reliable data. The ability to obtain relevant user feedback and informal discussion adds significant value to this study.
• Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study (e.g stroke, pacemaker placement, etc), or that would otherwise prevent acquisition of usable data by researchers.
• Bulbous residual limb shape causing inability to fit within system restrictions
• Open wounds on the residual limb
• Inability to understand the English language

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 26, 2021
• Study Start: July 6, 2018
• Primary Completion: January 11, 2024
• Study Completion: January 1, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

US (1)