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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Timed Up and Go Test (TUG) — 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.

Trial sites (1)

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