跳至主要内容
临床试验/NCT03822702
NCT03822702招募中不适用

An Alternative Perspective to Comprehend Handwriting Performance: Development and Applications of a Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH)

National Cheng-Kung University Hospital2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2016年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
125
试验地点
2
主要终点
Change in the total point score of three subtests of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)

研究概览

简要总结

The purpose of this study is to investigate the real-time kinetics of handwriting regarding the design of the utensil and fine motor performances from biomechanical perspectives. It includes three parts.

The first part is an observational study design and the specific aim of the first part of the study is to establish a novel kinetic assessment system incorporated with Force Acquisition Pens (FAPs) designed with different barrel sizes and shapes for handwriting. The thorough calibration, examination of reliability and validity will be presented in this study.

The second part is also an observational study design and the specific aim of the second part of the study is to investigate the handwriting mechanisms using the kinetic assessment system incorporated with the motion capture system with children who have writing difficulties.

The third part is an interventional study design and the aim of this final part is to integrate the kinetic assessment system and the intervention concept to establish a Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH). Comparison of the intervention effect of the BABSH and traditional training for the children with handwriting difficulties will also be carried out in this part.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to use pen to write
  • Children volunteers must study in elementary schools

排除标准

  • Handwriting problems are related to muscular, skeletal, nerve and brain damage or disease.

结局指标

主要结局

Change in the total point score of three subtests of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)

时间窗: baseline, 1.5 months

These three subtests are 'fine motor precision (subtest-1) ', 'fine motor integration (subtest-2)' and 'manual dexterity (subtest-3)'. The raw scores of the three subtests were then transformed into point scores based on the BOT-2 manual. The total point scores of the three subtests will be analyzed. For subtest-1, the range of total point score is 0 to 41. For subtest-2, the range of total point score is 0 to 40. For subtest-3, the range of total point score is 0 to 45. Higher total point scores represent a better performance (outcome).

Change in the result of Chinese Handwriting Evaluation Form

时间窗: baseline, 1.5 months

A questionnaire about handwriting performance. Each item is rated on a five-point ordinal scale

Change in the handwriting kinetic parameters

时间窗: baseline, 1.5 months

The kinetic parameters designed by measuring the real finger force applied on a force acquisitional pen.

Change in the handwriting kinematic parameters

时间窗: baseline, 1.5 months

The kinematic parameters designed by measuring the real hand motion using motion analysis system.

次要结局

  • Change in the pinch force(baseline, 1.5 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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