Single-Subject Research Design on 3D-Printed Prosthetic Sockets

NCT ID: NCT07329738

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2026-03-11

Brief Summary

The goal of this single-subject research design (clinical trial) is to assess the functionality of the 3D printed prostheses and to compare them to the existing prostheses in terms of mobility, balance, utility, and comfort. Participants who have a unilateral or bilateral transtibial amputation wear their existing prosthesis for roughly 3 weeks, followed by 3 weeks wearing a 3D printed prosthesis. The research assistants collect data throughout each period remotely, with the exception of one in-person visit to participants' homes to prepare the setting for the virtual evaluation sessions.

Detailed Description

Once a participant is recruited and consent is obtained, Phase (A) begins with the research assistants conducting one home visit with the participant. This visit sets up the performance-based outcome measures, provides instructions for performing the tests, explains how to complete the online surveys, and clarifies how to take the video recordings. The research assistants distribute the Sociodemographic and Clinical Characteristics questionnaire to the participant via the UBC Qualtrics platform.

During Phase (A), the participant wears their definitive prosthesis and is remotely evaluated up to three times per week for three weeks. At the end of Phase (A), the participant receives an online self-reported survey to measure the utility of using the definitive prosthesis.

The participant then attends their prosthetic clinic to have measurements and a scan of their residual limb taken for the 3D printed prosthesis. The prosthetists use the "Comb" mobile scanner application, and the scans of the participants are securely stored and de-identified to maintain the confidentiality of the participants' information through the HIPAA-compliant Comb portal. The research assistant prints the prosthesis, which includes implanting a thermal sensor into the prosthesis to monitor the wear time. The participant visits the prosthetic clinic a second time to have the 3D printed prosthesis fitted by the relevant prosthetist in the team. The prosthetist ensures the new prosthesis is properly fitted and appropriate for use before allowing the participant to go home with it.

In Phase (B), the participant uses the 3D-printed prosthesis for three weeks and conducts the same outcome measures. At the end of Phase (B), the participant receives an online self-reported survey to measure the utility of using the 3D printed prosthesis.

Participants drop off the 3D-printed prostheses at their prosthetic clinics at the end of the study. Then the RA collects all the 3D printed prostheses to keep them in a locked cabinet in the principal investigator's office at the University of British Columbia.

The participant then has a one-to-one virtual semi-structured interview to explore their experiences with the 3D printed prosthesis.

A separate focus group is conducted with prosthetists involved in this study to obtain their feedback and suggestions regarding the Limbkit.

Conditions

Transtibial Amputees

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Single group (one arm only)

Single-subject design (AB): therefore, each participant goes through two phases:

A= use regular prosthesis B= use 3D-printed prosthesis

Group Type: OTHER

3D printed prosthetic sockets

Intervention Type: DEVICE

The sockets are 3D printed using Polyethylene Terephthalate Glycol (PETG) filament. The printer used for this process is the Fused Deposition Modelling (Creality Ender 6), equipped with a 1.0 mm nozzle diameter, a print speed of 45mm/s, and a layer thickness of 2 mm. To enhance their strength, the sockets are reinforced with Delta-Lite® plus cast tapes and assembled using a distal push-lock mechanism and plate. The number of reinforcement wraps of the Delta-Lite® differs for each region of the socket. Below the sockets, the same prosthetic components from the previous prosthesis are utilized where possible. Participants wear their 3D printed sockets for an adjustment period (3-7 days) and then come in for a follow-up session to ensure the 3D socket still fits well after their limb has settled into the new system. Once both the prosthetist and participant are happy with the fit, Phase B testing is scheduled.

Interventions

3D printed prosthetic sockets

The sockets are 3D printed using Polyethylene Terephthalate Glycol (PETG) filament. The printer used for this process is the Fused Deposition Modelling (Creality Ender 6), equipped with a 1.0 mm nozzle diameter, a print speed of 45mm/s, and a layer thickness of 2 mm. To enhance their strength, the sockets are reinforced with Delta-Lite® plus cast tapes and assembled using a distal push-lock mechanism and plate. The number of reinforcement wraps of the Delta-Lite® differs for each region of the socket. Below the sockets, the same prosthetic components from the previous prosthesis are utilized where possible. Participants wear their 3D printed sockets for an adjustment period (3-7 days) and then come in for a follow-up session to ensure the 3D socket still fits well after their limb has settled into the new system. Once both the prosthetist and participant are happy with the fit, Phase B testing is scheduled.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• are adults 19+ years,
• have a unilateral or bilateral transtibial amputation,
• have an existing definitive prosthesis,
• use their definitive prosthesis two or more consecutive hours per day,
• have no wounds on the residual limb.

Exclusion Criteria

• are unable to adequately complete self-report measures or communicate well enough to participate in the end of project interview,
• have bilateral upper extremity amputations,
• have poorly controlled comorbidities (e.g., unstable diabetes, advanced heart problems)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

William C. Miller

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William C. Miller

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

F22-05611

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

F24-00369

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H22-03708

Identifier Type: -

Identifier Source: org_study_id