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临床试验/NCT05589324
NCT05589324已完成不适用

The Effectiveness of Different Angle of 3D Printing Writing Assisitive Device on Feasibility in Patients With Nerve Injury

Taipei Medical University Shuang Ho Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Writing task

研究概览

简要总结

Injury to the central or peripheral nerves can lead to limited hand function and further affect the ability of writing. The use of assistive devices can assist writing performance. However, the habit of holding the pen and the ability of the individual case will affect the selection of aids and the efficiency of writing. The 3D printing aids can be individually designed and adjusted to different angles and types. There is no criterion for 3D printing aids decision, often using a case-by-case trial subjective way to confirm, matching takes more time. Aim: To compare the applicability and efficiency of different types of 3D-printed writing aids in nerve injury cases, and to explore which factors affect the choice of aids.

详细描述

Background: Injury to the central or peripheral nerves can lead to limited hand function and further affect the ability of writing. The use of assistive devices can assist writing performance. However, the habit of holding the pen and the ability of the individual case will affect the selection of aids and the efficiency of writing. The 3D printing aids can be individually designed and adjusted to different angles and types. There is no criterion for 3D printing aids decision, often using a case-by-case trial subjective way to confirm, matching takes more time. Aim: To compare the applicability and efficiency of different types of 3D-printed writing aids in nerve injury cases, and to explore which factors affect the choice of aids.

Methods: Thirty subjects were recruited from outpatient rehabilitation of neurologically injured patients with limited hand function. Their basic information was recorded, including basic abilities, palm and finger size, and pen-holding posture, etc. Using three different angles of 3D printing writing aids, the writing efficiency and the satisfaction of the aids are evaluated by the writing task and the Satisfaction with Assistive Technology. Collected data were analyzed by SPSS (Version 20.0). The significance level of the statistical value is set at 0.05. The basic data and evaluation items of the subjects are observed by descriptive statistical analysis. All the analyzed values will be presented in the form of mean ± standard deviation. The Wilcoxon test is used to compare before and after the use of assistive devices. Data between different aids were analyzed by one-way analysis of variance (ANOVA) with Bonferroni adjustment; basic data and aids choice were analyzed by Pearson's Chi-Square correlation analysis; liner regression was used, and Backward regression was used to confirm whether the variable was removed (p>0.1), and univariate analyses in a general linear manner were used to analyze whether the independent variables of the basic data affected the choice of assistive devices.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The medical record shows that the diagnosis is central or peripheral nerve injury, and the onset is more than three months
  • The trunk is well controlled and can sit stable on the chair
  • The affected hand can control the lifting of the shoulder and the bending of the elbow, and the forearm can be controlled.
  • The affected hand is the dominant hand and has difficulty writing

排除标准

  • Aged over 75 and under 20
  • Cognition or visual perception impairment that affects their ability to copy
  • Patients suffer from other diseases of the nervous, cardiopulmonary, and musculoskeletal systems that affect the subject's performance of the movements required by this test.

结局指标

主要结局

Writing task

时间窗: From date of writing task until 4 situations complete, assessed up to 1 session. Each session lasting 60 minutes within one day.

The individual is asked to copy short sentences in four situations including no wearing aids, writing aids with three angles (5 degrees, 20 degrees, 30 degrees). Calculate the time and quality it takes to complete 10 words. To record its speed, quality (the legibility of the correct number of words, the size of the writing, the number of times it exceeds the line, whether the strength is sufficient and consistent).

次要结局

  • Assistive device satisfaction scale(From date of writing task until 4 situations complete, assessed up to 1 session. Each session lasting 60 minutes within one day.)

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsinchieh Lee

Principal Investigator

Taipei Medical University Shuang Ho Hospital

研究点 (1)

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