Evaluating User Satisfaction and Feasibility of a Remote-digital Model for 3d Scanning and Printing of Prosthetic Sockets for Patients With Transtibial Amputation: A Preliminary Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Socket Comfort Score
研究概览
简要总结
The goal of this clinical trial is to investigate the repeatability of application of a fully remote method of manufacturing 3D printing of prosthetic sockets for transtibial amputees, and determine user satisfaction of sockets produced through these methods. The study also aims to evaluate the time and cost effectiveness of this production model.
The main question[s] it aims to answer are:
- To determine the repeatability and user satisfaction with transtibial sockets produced using a remote-digital method as compared to conventional manufacturing methods.
- To determine if transtibial prosthetic users have greater prosthetic satisfaction scores across the 4 Prosthesis Evaluation Questionnaire (PEQ) subscales of Utility (UT), Appearance (AP), Sounds (SO) and Residual Limb Health (RL) with the 3D printed socket fabricated through the remote-digital method compared to the laminate socket made using the conventional method.
- To determine if transtibial prosthetic users experience greater socket comfort with the 3D printed socket compared to the laminate socket.
Participants will receive a 3D printed socket (trial intervention) and a laminate socket (control intervention) and will use each socket for a period of 4 weeks.The order of socket use will be randomised. At the end of each 4 week period, participants will rate their comfort and satisfaction with the socket. At the end of the trial, participants will indicate their preferred socket, which will be fitted to their prosthesis.
Participants will attend 6 visits across a total duration of 11 weeks during the course of the study.
详细描述
The visit schedule for the study is as follows:
- Visit 1 (Week 0): Attain consent and initiate casting and scanning process for 1 laminate and 1 3D printed transtibial socket
- Visit 2 (Week 3): Fitting and adjustment of first prosthetic socket (either 3D printed or laminate socket). Subjects to rate comfort of first socket.
- Visit 3 (Week 5): Follow-up on any required device adjustments/ troubleshooting to first socket.
- Visit 4 (Week 7): Evaluation of user satisfaction with first socket. Subjects to fill up survey on first socket. Fitting of other socket design (second socket). Subjects to rate comfort of second socket.
- Visit 5 (Week 9): Follow-up on any required device adjustments/ troubleshooting to second socket.
- Visit 6 (Week 11): Evaluation of user satisfaction with second socket. Subjects to fill up survey on second socket and select their preferred socket. Fitting of patient's preferred socket to prosthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral transtibial amputation, current transtibial prosthetic users minimally capable of community ambulation (mobility grades K2 - K4) who have completed gait training, current users of a roll on elastomeric or silicone liner system, and aged 21 years old and above to be able to provide informed consent.
排除标准
- •Functional status: patients with severe aphasia or neglect (inability to obey 1 step commands), communication disorders precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.
- •Mobility status: patients who are non-community ambulators (mobility grade K1) or who have not completed gait training
- •Active limb conditions: uncontrolled lower limb volume fluctuations, severe stump varus or valgus deformities and/or lower limb contractures of over 10 degrees, or with local limb conditions which could be exacerbated by research interventions such as open wounds, ulcers, stump pain or stump wounds/ulcers, neuromas, active arthritis or joint or limb pain.
- •Reproductive age females should not be pregnant during the study.
结局指标
主要结局
Socket Comfort Score
时间窗: at initial socket fitting and 4 weeks post-fitting
Self-reported socket comfort is rated from 0 - 10, where 0 is the most uncomfortable socket imaginable and 10 the most comfortable.
Prosthesis Evaluation Questionnaire
时间窗: after 4 weeks of socket use
Subscales of Utility, Appearance, Sounds and Residual Limb Health, and an individual satisfaction question
次要结局
未报告次要终点
研究者
Tabitha Quake
Principal Prosthetist/Orthotist
Tan Tock Seng Hospital