跳至主要内容
临床试验/NCT05837273
NCT05837273招募中不适用

The Feasibility Usability and Effectiveness of Fully Immersive Horticultural-based Virtual Reality Cognitive Training for Community-dwelling Elderly

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
2
主要终点
Change scores of Stroop test

研究概览

简要总结

The pilot study will be a novel investigation of the usability and feasibility of leisure activities-based fully immersive VR cognitive training systems for cognitive training. We will recruit healthy aged individuals and occupational therapists for usability plus feasibility evaluation and perform the comparison of the effect with the developed VR intervention on psychological, daily life function and quality of life outcomes in populations experiencing cognitive decline. The fully-immersive VR system applied with horticultural therapy will be conducted in cognitive training and it was equipped with a headset and a pair of controllers for motion estimation and monitoring in a virtual environment. The findings of the research will effectively lead to advancement of the fully immersive leisure-based virtual reality cognitive training for elderly with cognitive decline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Occupational therapists
  • Have clinical experience for more than one year
  • Healthy aged Individuals:
  • An initial MoCA scores ≧ 20
  • age between 60 to 85
  • ability to follow instructions and perform tasks
  • willing to provide written informed consent

排除标准

  • Occupational therapists
  • History of severe dizziness or epilepsy
  • Unstable physical conditions accompanied by neurological or other orthopedic diseases may affect immersive VR experience
  • Recent diagnosis of psychiatric disorders
  • Healthy aged individuals:
  • An initial MoCA scores lower than 20
  • History of psychiatric disorders, major perceptual (visual or auditory) impairments, migraine or epilepsy, motion-sickness sensitive, unable to provide informed written consent due to severe cognitive impairment
  • [Effect study]
  • Inclusion Criteria:
  • An initial MoCA scores ≧ 20
  • age between 60 to 85
  • ability to follow instructions and perform tasks
  • willing to provide written informed consent
  • Exclusion Criteria:
  • An initial MoCA scores lower than 20
  • History of psychiatric disorders, major perceptual (visual or auditory) impairments, migraine or epilepsy, motion-sickness sensitive, unable to provide informed written consent due to severe cognitive impairment

结局指标

主要结局

Change scores of Stroop test

时间窗: baseline, after the intervention eight weeks, and at 3-month follow-up

The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. The time to complete the task will be calculated for each condition

Change scores of Color trials test

时间窗: baseline, after the intervention eight weeks, and at 3-month follow-up

For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.

Change scores of Montreal Cognitive Assessment

时间窗: baseline, after the intervention eight weeks, and at 3-month follow-up

The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.

Change scores of Wechsler Memory Scale

时间窗: baseline, after the intervention eight weeks, and at 3-month follow-up

Including Faces Recognition (total scale=48), Verbal Paired Associates (total scale = 32), Word Lists (total scale = 48), and Spatial Span (total scale=32) will be used to assess the immediate, delayed, and working memory tests. For each subtest, a higher number indicates better performance in memory function. The raw score of subtests will also be transferred to standardized Z scores and summed to represent an index of general memory function.

次要结局

  • Change scores of Community Integration Questionnaire, CIQ(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of Timed up and go (TUG)(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of short physical performance battery,SPPB(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of Wechsler Adult Intelligence Scale; WAIS(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of the World Health Organization Quality of Life-Old(WHOQOL-OLD(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of Geriatric Depression Scale (GDS)(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of The Chinese Aging Well Profile (CAWP)(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of the short (12-item) form of the Everyday Cognition Scale (ECog-12)(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of WHOQOL-bref Taiwan Version(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of 30 second chair stand test,CST(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of Reported Edmonton Frail Scale (REFS)(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of The Clinical Frailty Scale (CFS)(baseline, after the intervention eight weeks, and at 3-month follow-up)
  • Change scores of International Physical Activity Questionnaires (IPAQ)(baseline, after the intervention eight weeks, and at 3-month follow-up)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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