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临床试验/NCT05903391
NCT05903391已完成不适用

Splint Users' Satisfaction and Functional Status With Custom Finger Splints: A Feasibility and Comparison Study

Endeavor Health4 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年11月9日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natasha Irani

OTD, OTR/L: Occupational Therapist

Endeavor Health

研究点 (4)

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