Splint Users' Satisfaction and Functional Status With Custom Finger Splints: A Feasibility and Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Modified Version of Orthotics and Prosthetics User Survey - Satisfaction with Device
研究概览
简要总结
This feasibility and non-randomized comparison study explores the possible benefits of splint design and production by 3D-printing in a clinical setting and looks at splint users' experiences with customizable 3D-printed finger splints compared to conventionally made splints. Fifty participants with a hyperextended finger condition are assigned by researcher to either an interventional group (customizable 3D-printed finger splint) or a control group (conventional thermoplastic finger splint). Participants will wear assigned splint for 1 month. Functional status and satisfaction with splint will be assessed at the end of the 1-month duration in the form of surveys on satisfaction and functional status participants will be asked to complete. The findings will contribute to evidence that customizable 3D-printed finger splints can serve as a feasible, cost-effective option to improve patient satisfaction and functional status. It will further justify the need for the application of 3D-printing in a clinical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English
- •18 years or older
- •Finger proximal interphalangeal joint (PIP) joint hyperextension (with or without swan-neck deformity)
- •Pregnant or not pregnant women
- •Able to tolerate a finger orthosis over the course of 1 month
- •Not decisionally impaired
- •Have or have not previously worn a finger orthosis for symptoms
排除标准
- •Non-fluent in English
- •Decisionally impaired
- •Younger than 18 years old
- •No proximal interphalangeal joint (PIP) joint finger hyperextension
- •Unable to tolerate a finger orthosis over the course of 1 month
结局指标
主要结局
Modified Version of Orthotics and Prosthetics User Survey - Satisfaction with Device
时间窗: 1 month
A modified version of a Self-report questionnaire which measures participants satisfaction with assigned splint device
Modified Version of Orthotics and Prosthetics User Survey - Functional Status
时间窗: 1 month
A modified version of a Self-report questionnaire which measures participants' functional status during the duration of time wearing assigned finger splint device
次要结局
未报告次要终点
研究者
Natasha Irani
OTD, OTR/L: Occupational Therapist
Endeavor Health
