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NCT Number: NCT07329738

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Transtibial Amputees

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, V6T 2B5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Timed Up and Go Test (TUG)

    Time frame: 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.

    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.

Secondary outcomes

  1. Four Square Step Test (FSST)

    Time frame: 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.

    Multi-directional stepping through four square positions (sequence: 1→2→3→4→1→4→3→2→1); time is recorded from initial stance in square one until returning to square one. The FSST score is the average of two timed trials.

  2. Activities-Specific Balance Confidence Scale (ABC)

    Time frame: 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.

    A 16-item questionnaire that assesses confidence in avoiding balance loss across daily activities (e.g., walking on an icy sidewalk). Scores range from 0%-100%, with higher scores indicating greater confidence. The ABC score is the average of the 16 items.

  3. Socket comfort was measured with the Socket Comfort Score (SCS)

    Time frame: 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.

    A single-item measure adapted from pain scales in which 0 = extreme discomfort and 10 = optimal comfort.

Other outcomes

  1. Prosthesis evaluation questionnaire (PEQ)

    Time frame: 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.

    The questions in the self-report survey (mobility, pain, and utility) are adopted from the well-developed questionnaire, Prosthesis Evaluation Questionnaire (PEQ), for people with lower limb amputation.

    The mobility scale: scores range from 0 to 100, with higher scores indicating better mobility.

    The pain questions include (intensity and frequency) items:

    The pain intensity scores range from 0 to 100. Higher scores indicate less intense pain.

    The pain frequency scores range from 0 to 6, where 0 means "never" and 6 means "all the time" or "almost all the time." Higher scores indicate more frequent pain.

    The utility scale: scores range from 0 to 100, with higher scores indicating better prosthesis utility

  2. Short Physical Performance Battery (SPPB)

    Time frame: 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.

    SPPB includes static standing balance in three postures for 10 seconds, lower limb strength of getting up and sitting on a chair without using the arms, and walking speed at a normal pace. Component scores are summed to produce a total score ranging from 0 to 12. Higher total scores indicate better lower-extremity function/physical performance.

  3. Figure of Eight Walk Test (F8WT)

    Time frame: 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.

    This test requires participants to walk a figure-of-8 around two cones placed 1.5 m apart. The F8WT score is the average of two-timed trials.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

A 3D-Printed Prosthesis Portable Station: The Vancouver Limbkit Project

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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