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临床试验/NCT05343468
NCT05343468已完成不适用

Independence, Quality of Life, and Adaptive Behavioral Skills Improved in Children With Down Syndrome After Using Assistive Technology

MapHabit, Inc.2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年9月20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
26
试验地点
2
主要终点
Change in Adaptive Behavior Assessment System Third Edition (ABAS-3) from Baseline at 4 Weeks

研究概览

简要总结

Enhancing independence and quality of life are key modifiable outcomes that are short- and long-term goals for children with Down syndrome (DS) and for their parents. The study investigated the efficacy of assistive technology in improving children with Down Syndrome's independence and quality of life. Using a commercially available assistive technology, the MapHabit system, the investigators implemented the software with participants' families for 4 weeks. The investigators hypothesized that the assistive technology will improve adaptive behavioral skills and overall quality of life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Down syndrome diagnosis
  • Age between 7-17
  • Internet access
  • Proficiency in English

排除标准

  • Ages outside of 7-17
  • Located outside of the United States of America
  • No internet access
  • No proficiency in English

结局指标

主要结局

Change in Adaptive Behavior Assessment System Third Edition (ABAS-3) from Baseline at 4 Weeks

时间窗: Pre-Post: The assessment was administered at the beginning and end of the study's duration (4-week study).

Assessment is used commonly for children with Down syndrome that evaluates conceptual, social, and practical behavioral skills that are significant for day-to-day functioning. The assessment is scored with the General Adaptive Composite (GAC), which summarizes performance across all adaptive skill areas. GAC score ranges from 0-130, with a higher score indicating better outcome.

Quality of Life - 18 (QoL-18)

时间窗: The instrument was administered to the participants after the completion of the study duration (4-week study).

18-item quality-of-life questionnaire (QoL-18) evaluated a range of participants' behaviors, including mood, engagement, and memory at the end of the study compared to before the use of the MHS. The instrument is scored on a Likert Scale, ranging from 1-5. A higher number indicates better outcome.

次要结局

未报告次要终点

研究者

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

Stuart Zola

Chief Scientific Officer

MapHabit, Inc.

研究点 (2)

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