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

NCT07329738 | Active Not Recruiting

• 3 other identifiers: H22-03708F22-05611F24-00369
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Transtibial Amputees

Outcome Measures

Primary Outcomes (1)

• Timed Up and Go Test (TUG)

  Participants rise from a chair, walk three meters, turn around a cone, return to the chair, and sit; time is recorded from start (standing) to finish (sitting). The TUG score is the average of two timed trials.

  Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.

Secondary Outcomes (3)

• Four Square Step Test (FSST)

  Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.

• Activities-Specific Balance Confidence Scale (ABC)

  Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.

• Socket comfort was measured with the Socket Comfort Score (SCS)

  Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.

Other Outcomes (3)

• Prosthesis evaluation questionnaire (PEQ)

  Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B. Utility scale measurements are taken twice; once at the end of phase A and again at the end of phase B.

• Short Physical Performance Battery (SPPB)

  Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.

• Figure of Eight Walk Test (F8WT)

  Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.

Study Arms (1)

Single group (one arm only)

OTHER

Single-subject design (AB): therefore, each participant goes through two phases: A= use regular prosthesis B= use 3D-printed prosthesis

Device: 3D printed prosthetic sockets

Interventions

3D printed prosthetic sockets 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.

Single group (one arm only)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 2B5, Canada

Location

Study Officials

• William C. Miller

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-subject design (AB): therefore, each participant goes through two phases: A= use regular prosthesis B= use 3D-printed prosthesis

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 9, 2026
• Study Start: July 17, 2023
• Primary Completion: January 24, 2025
• Study Completion: March 11, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)