Feasibility, Usability, and Acceptability of Virtual Reality-Based Cognitive and Physical Rehabilitation in Individuals With Mild Cognitive Impairment ((VR-MCI))
2026年8月28日 更新者：Seema S Aggarwal、The University of Texas Health Science Center, Houston
Feasibility, Usability, and Acceptability of Virtual Reality-Based Cognitive and Physical Rehabilitation in Individuals With Mild Cognitive Impairment (VR-MCI)
The purpose of this study is to demonstrate feasibility, usability, and acceptability of virtual reality (VR)-based cognitive and physical rehabilitation, evaluate adherence, tolerability, and fidelity to the VR intervention and explore preliminary effectiveness of VR-based rehabilitation on cognitive, physical, and functional outcomes.
研究概览
研究类型
介入性
注册 (估计的)
10
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Seema S Aggarwal, PhD, APRN, AGNP-C
- 电话号码：(713) 500-9946
- 邮箱：Seema.S.Aggarwal@uth.tmc.edu
研究联系人备份
- 姓名：Tela Todd
- 电话号码：(713) 500-7039
- 邮箱：Tela.Todd@uth.tmc.edu
学习地点
-
-
Texas
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Houston、Texas、美国、77030
- 招聘中
- The University of Texas Health Science Center at Houston
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接触：
- Tela Todd
- 电话号码：(713) 500-7039
- 邮箱：Tela.Todd@uth.tmc.edu
-
接触：
- Seema Aggarwal, PhD, APRN, AGNP-C
- 电话号码：(713) 500-9946
- 邮箱：Seema.S.Aggarwal@uth.tmc.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Clinical diagnosis of MCI (MoCA 18-26) or self-reported subjective cognitive decline (SCD)
- Capacity to provide informed consent
- Able to provide own transportation to sessions
- Speaks and understands English
- Ambulatory
Exclusion Criteria:
- Uncontrolled seizures or epilepsy
- Severe psychiatric illness or active suicidality
- Inability to follow instructions or tolerate VR (severe motion sickness)
- Cognitive impairment as a result of a known cause (e.g., dementia, stroke, Traumatic Brain Injury (TBI), medications, etc.)
- Any condition that the research team determines would interfere with safe participation
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Virtual Reality (VR) sessions
|
Participants will complete 3 supervised virtual reality (VR) sessions per week for 6 weeks for a total of 18 sessions using either the Real System VR headset or the Oculus Quest 2 VR headset.
Each session will last approximately 60 minutes, with time allocated for setup and brief symptom checks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility as assessed by the recruitment rate
大体时间：from baseline to end of intervention (6 weeks)
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from baseline to end of intervention (6 weeks)
|
|
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Feasibility as assessed by the retention rate
大体时间：from baseline to end of intervention (6 weeks)
|
from baseline to end of intervention (6 weeks)
|
|
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Feasibility as assessed by the session completion rate
大体时间：from baseline to end of intervention (6 weeks)
|
from baseline to end of intervention (6 weeks)
|
|
|
Usability as assessed by the System Usability Scale (SUS)
大体时间：Post-intervention only (Final visit at 6 weeks)
|
The System Usability Scale (SUS) is a validated 10-item questionnaire used to assess participants' perceived usability of the intervention.
each rated on a 5-point Likert scale from 1 = Strongly Disagree, 2 = Disagree 3 = Neutral ,4 = Agree, 5 = Strongly Agree.
Scores range from 0 to 100, with higher scores indicating greater usability.
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Post-intervention only (Final visit at 6 weeks)
|
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Acceptability / Presence as assessed by the Presence Questionnaire (PQ)
大体时间：Post-intervention only (Final visit at 6 weeks)
|
This is a 29 item questionnaire, each is scored on a seven-point Likert-type scale with a score range form 29-203. Higher scores indicate a greater sense of presence or immersion in the virtual environment.
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Post-intervention only (Final visit at 6 weeks)
|
|
Tolerability / Side Effects as assessed by the Simulator Sickness Questionnaire (SSQ)
大体时间：Before + immediately After each VR session
|
This is a 16 item questionnaire and each is scored form 0(none) to 3(severe).
Scores are combined using weighted subscales to generate a total score, with higher scores indicating greater simulator sickness
|
Before + immediately After each VR session
|
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Adherence / Engagement as assessed by the session attendance as entered in VR system logs
大体时间：Post-intervention only (Final visit at 6 weeks)
|
Post-intervention only (Final visit at 6 weeks)
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|
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Adherence / Engagement as assessed by the time from start to end of VR session as entered in VR system logs
大体时间：Post-intervention only (Final visit at 6 weeks)
|
Post-intervention only (Final visit at 6 weeks)
|
|
|
Adherence / Engagement as assessed by the number of repetitions of the activity as indicated by device metrics
大体时间：Post-intervention only (Final visit at 6 weeks)
|
Post-intervention only (Final visit at 6 weeks)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Seema Aggarwal, PhD, APRN, AGNP-C、The University of Texas Health Science Center, Houston
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月18日
初级完成 (估计的)
2026年11月13日
研究完成 (估计的)
2026年11月13日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月9日
首次发布 (实际的)
2026年6月10日
研究记录更新
最后更新发布 (实际的)
2026年9月2日
上次提交的符合 QC 标准的更新
2026年8月28日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.