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临床试验/NCT06843733
NCT06843733已完成不适用

Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes in Healthy Older Adults and People With Mild Cognitive Impairment

Mahidol University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年5月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Single-task performance

研究概览

简要总结

The executive dysfunctions are a problem in individuals with MCI which predict conversion to dementia and is positively related to physical activity level. Previous studies found that exercise can prevent executive and physical dysfunctions for people with MCI. However, the motivation is a critical factor in supporting a sustainable exercise. Exergame is combination of exercise and video game. Enjoyment during playing an exergame can support the exercise motivation. Therefore, we will explore the feasibility of using MR exergame in people with MCI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy group: 1) MoCA score > 24; 2) Independent walking without using gait aids; 3) No diagnosis of the dementia by clinician.
  • •MCI group: 1) MoCA score between 16 to 24; 2) Independent walking without using gait aids.

排除标准

  • •Uncontrolled high blood pressure (more than 140/90 mmHg)
  • •Hemodialysis
  • •Have clinical diagnosis of the disease or symptoms that could influence the performance assessments such as arthritis or severe hand pain which reports by participants and the testing by physiotherapist before testing.
  • •History of neurological disorder, such as stroke or other neurodegenerative disorder
  • •Taking medicine which affected to functional movement.
  • •Unable to follow study protocol.
  • •Uncorrected visual or hearing impairment.
  • •Positive screening for contraindication of TMS which will be confirmed by TMS screening questionnaire such as uncontrolled seizures.

研究组 & 干预措施

Mild cognitive impairment

Experimental

干预措施: Mixed reality exergame (Other)

Mild cognitive impairment

Experimental

干预措施: Education (Other)

Healthy older adults

Other

干预措施: Mixed reality exergame (Other)

结局指标

主要结局

Single-task performance

时间窗: before and immediately after intervention

Box and Block Test

Dual-task performance

时间窗: before and immediately after intervention

Box and Block with Serial Sevens Test

Visual attention and task switching

时间窗: before and immediately after intervention

Trail Making Test

Inhibitory control

时间窗: before and immediately after intervention

Color-Word Stroop Test

Cortical outcomes

时间窗: before and immediately after intervention

Transcranial magnetic stimulation was used for measuring the cortical outcomes, which consist of resting motor threshold, input-output curve of motor evoked potentials recruitment and cortical silent period.

Usability

时间窗: immediately after Mixed reality exergaming

System usability scale questionnaire was used for measuring the usability of mixed reality exergame. It consists of 10-item, which are typically rated on a five-point scale. A higher SUS score generally indicates better usability.

Motivation

时间窗: immediately after Mixed reality exergaming

Intrinsic Motivation Inventory was used for measuring the motivation. It rated on seven-point scale. Higher IMI scores reflect higher levels of motivation.

Adverse side effects

时间窗: immediately after Mixed reality exergaming

Cybersickness in Virtual Reality Questionnaire was used for assessing cybersickness symptoms, including nausea, vestibular, and oculomotor. The total score is the sum of the three sub-scores. Each question is presented on a 7-item Likert Scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rommanee Rojasavastera

Principal Investigator, Faculty of Physical Therapy, Mahidol University

Mahidol University

研究点 (1)

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