跳至主要内容
临床试验/NCT04384978
NCT04384978已完成不适用

Development of Serious Games and Physical Activities Instructed by a Social Robot for Improving the Well-being of Elderly Individuals With Alzheimer's Disease and Dementia

DreamFace Technologies, LLC2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年1月12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
22
试验地点
2
主要终点
Change in Cognitive/Memory Ability

研究概览

简要总结

A 12-month pilot study will be comprised of two groups of people diagnosed with mild Alzheimer's disease and related dementia for a total of 80 senior subjects. Subjects will be randomly assigned to two groups: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. Group 2 (Active Control Group) will play solitary games and activities but will have to interaction with Ryan. The team will measure the changes and improvement in the social/emotional well-being of these two groups and eventual changes in the cognitive/memory functions of elderly people living in the similar environment.

研究设计

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

入排标准

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

入选标准

  • Age ≥ 65 years
  • Early Alzheimer's disease and related dementia diagnosed by a qualified provider
  • Saint Louis University Mental Status (SLUMS) score between 10 and 25
  • Resident of assisted living facility for at least one month prior and for the duration of the study
  • Deemed conditioned enough to participate in physical activities after a wellness check
  • Verbal skill to interact
  • Participant or Legal decision

排除标准

  • Aggressive behavior
  • Diagnosed with severe dementia or memory loss
  • Acute physical illness that impairs ability to participate
  • Patients with serious comorbidity, tumors and other diseases casually related to cognitive impairment
  • History of alcohol or drug abuse, head trauma, psychoactive substance use and other causes of memory impairment
  • Significant sensory impairment

结局指标

主要结局

Change in Cognitive/Memory Ability

时间窗: assessed at baseline (week 1), week 4, and 8. Week 8 reported.

Participants will complete the Saint Louis University Mental Status (SLUMS) test, a screening method for Alzheimer's and other dementia. Scores range from 0 to 30. Scores of 27 to 30 are considered normal in a person with a high school education. Scores between 21 and 26 suggest a mild neurocognitive disorder. Scores between 0 and 20 indicate dementia.

次要结局

未报告次要终点

研究者

发起方
DreamFace Technologies, LLC
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Mohammad Mahoor

Founder and CEO

DreamFace Technologies, LLC

研究点 (2)

Loading locations...

相似试验