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临床试验/NCT04037579
NCT04037579Unknown不适用

Protocol for a Non-randomized Survey to Evaluate Social Skills and Physical Capacity Improvement in Down Syndrome People Who Routinely Practice Sports. Self and Observers´ Perception.

Universidad de Córdoba1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年9月26日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Sport effect on social skills in Down Syndrome people

研究概览

简要总结

This survey arises from one objective of a PhD thesis whose purpose is to "Identify what social skills people with Down syndrome have that do a routine activity and compare them with those developed by those SD people who perform sports activities."

详细描述

This study is a non-randomized survey. The aim of the current protocol is to describe how will be the process to get information about the participant, the questionnaire design and how was validated and the planned analysis of results.

Participants: Around 150 Down Syndrome people from Cordoba, Malaga y Granada who belong to The Down Syndrome association and 150 parents, family, tutors, teachers etc.

Consent process: Before designing the survey, consent was requested from the management team Down of Córdoba, Malaga and Gradana associations, as well as family members, parents, tutors, teachers, etc.

Standard Operating Procedures: First, RC (author) gathered as much information as possible about the subject under study and selected the most important topics related to the research focus. After that, the questionnaire was designed modifying the KidsLife-Down Scale. The questionnaire will be divided into three parts.

An introduction to the questionnaire describes the instructions, structure, the reasons for the study and confidentiality in accordance with the Spanish Organic Law 3/2018 on the Protection.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Other

入排标准

年龄范围
10 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Down syndrome
  • •Belonging to Cordoba, Mágala and Granada Associatio

排除标准

  • •Others metal incapacities
  • •Others Asociation

结局指标

主要结局

Sport effect on social skills in Down Syndrome people

时间窗: 6 months

To Evaluate sport effect on social skills in Down Syndrome people using a survey

次要结局

  • Types of physical activities carried out by Down Syndrome people(6 months)

研究者

发起方
Universidad de Córdoba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Estrella Agüera Buendía

Professor. Responsible of AGR-019 Research Group

Universidad de Córdoba

研究点 (1)

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