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临床试验/NCT05522946
NCT05522946撤回不适用

Circle Game Collaborative--Freddie the Frog

Ohio State University2 个研究点 分布在 1 个国家开始时间: 2021年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Establish the feasibility of cooperative gameplay between parents and adolescents with disabilities

研究概览

简要总结

Families who have children with disabilities experience more challenges in interacting with their children than families who have children without disabilities. This increased level of burden results in higher rates of emotional stress and hardship for those families. Motivated by the idea of making deeper connections between children with disabilities and their parents, our gaming platform is designed around two key concepts - human touch and collaborative play. Using wearable sensors, conductive fabrics, microcontrollers, and wireless communication, our gaming platform will register and interpret "touch" as a way to interface with game apps and the devices they are installed on. In other words, touch is translated into player input. Thus, rather than interact with an iPad directly, children and their parents interact with each other instead. Our platform engages both parents and children with disabilities equally in order to better focus on their shared physical expression. As touch can be registered from any part of the body, our platform can be used with children with any type of disability and allows for both active and passive participation by children with a severe disability.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Group 1: Children without disabilities between the ages of 5-9 years. Any parent/caregiver to the child
  • Group 2: Adolescents with mild to moderate physical or cognitive disability between the ages of 10-17 years. Any parent/caregiver to the child
  • Group 3: Adolescents with moderate to severe physical and/or cognitive disability between the ages of 10-17 years. Any parent/caregiver to the child

排除标准

  • All groups:
  • Parents who do not understand and speak English
  • Parents with a disability

结局指标

主要结局

Establish the feasibility of cooperative gameplay between parents and adolescents with disabilities

时间窗: 1 hour

Successful completion of gameplay session

Establish the feasibility of cooperative gameplay between parents and children without disabilities

时间窗: 1 hour

Successful completion of gameplay session

Examine childs', adolescents', and parents ability to play the game through analysis of video recordings of game play

时间窗: 1 hour

Successful completion of gameplay session

次要结局

  • Compare whether the child had stress using the Visual Analog Scale in Group 1, Group 2, and Group 3(Immediately pre-gameplay and 1 hour post-gameplay)
  • Compare whether the parent had stress using the Visual Analog Scale in Group 1, Group 2, and Group 3(Immediately pre-gameplay and 1 hour post-gameplay)
  • Explore childs' and adolescents' Global, Mental, Physical, and Social Health using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure(Pre-gameplay)
  • Explore whether the child had stress pre/post gameplay using visual analog scale(Pre gameplay and immediately post gameplay)
  • Explore the parents' feelings of bonding with their child/adolescent using the "Connection & Bonding Questionnaire"(1 hour post-game play)
  • Explore whether the parent had stress pre/post gameplay using visual analog scale(Pre gameplay and immediately post gameplay)
  • Compare the parents' feelings of bonding using the "Connection & Bonding Questionnaire" with their child/adolescent in Group 1, Group 2, and Group 3(1 hour post-gameplay)
  • Semi-Structured interviews with open-ended questions to explore childs' and adolescents' (where appropriate), and parents' feelings about gameplay for fun, well being, quality of life(Immediately Post-gameplay and up to one week post-gameplay)
  • Explore whether the parent felt that their child's physical and psychological needs were met before gameplay using the "Child Needs Survey"(Pre-gameplay)
  • Explore whether the child had pain pre/post gameplay using visual analog scale(Pre gameplay and immediately post gameplay)
  • Semi-structured interviews with open ended questions to compare childs' and adolescents' (where appropriate), and parents' feelings about gameplay for fun, well being, quality of life in Group 1, Group 2, and Group 3(1 hour post-gameplay)
  • Compare whether the child had pain using the Visual Analog Scale in Group 1, Group 2, and Group 3(Immediately pre-gameplay and 1 hour post-gameplay)
  • Compare childs' and adolescents' Global, Mental, Physical, and Social Health using the single measure "Patient-Reported Outcomes Measurement Information System (PROMIS)" from Group 1, Group 2, and Group 3(1 hour post-gameplay)
  • Explore whether the parent had pain pre/post gameplay using visual analog scale(Pre gameplay and immediately post gameplay)
  • Compare the parents' feelings of whether the child's physical and psychological needs were met before gameplay using the "Child Needs Survey" in Group 1, Group 2, and Group 3(1 hour post-gameplay)
  • Compare whether the parent had pain using the Visual Analog Scale in Group 1, Group 2, and Group 3(Immediately pre-gameplay and 1 hour post-gameplay)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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