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临床试验/NCT07005271
NCT07005271已完成不适用

Investigation of the Effects of Virtual Reality-Based Hand Exercises on Cognitive Function and Hand Dexterity in Older Adults With Mild Cognitive Impairment.

Istinye University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2025年10月16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
29
试验地点
1
主要终点
Activities of daily living (Duruöz Hand Index)

研究概览

简要总结

This study aims to investigate the effects of virtual reality (VR)-based hand exercises on cognitive functions and hand skills in older adults with mild cognitive impairment (MCI). Cognitive functions will be assessed by measuring brain activity using functional near-infrared spectroscopy (fNIRS) during the Stroop test. Additionally, hand functions will be evaluated using the Minnesota Manual Dexterity Test, grip strength measurement (via a Jamar dynamometer), and the Duruöz Hand Index. Hand dominance will be determined using the Edinburgh Handedness Inventory, and sociodemographic data will be collected through a form prepared by the researcher. Based on a G*Power analysis, a total of 30 participants-15 in each group-will be included in the study, with an effect size of 1.00094 and a power of 80%. Evaluations will be conducted twice, before and after the intervention. To avoid participant fatigue, assessments will be divided over two days. The intervention group will receive VR-based hand exercises twice a week for six weeks. These exercises will include activities such as MasterChef (cutting, mixing, and grasping in a virtual kitchen), PinchPeg (placing pegs using pinch grip), HoldAndPut (transporting cups or cans), and bPuzzle (color matching and puzzle completion). The control group will perform traditional exercises twice a week for six weeks, including 30-50 piece puzzle completion, the Nine-Hole Peg Test, shape cutting, and number-color matching tasks. The study will be conducted with volunteer participants at the Istanbul Metropolitan Municipality Darülaceze Directorate, and written and verbal informed consent will be obtained from all participants in accordance with the principles of the Declaration of Helsinki.

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
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged between 65 and 75 years.
  • •Diagnosed with mild cognitive impairment by the institution's physician during routine examination.
  • •Ability to understand and follow verbal instructions.

排除标准

  • •Presence of neurodegenerative diseases affecting cognitive functions.
  • •Auditory or visual impairments that could interfere with rehabilitation implementation and communication.
  • •Upper extremity disorders, including severe shoulder, elbow, wrist, or finger impairments, bilateral elbow, hand or wrist fractures, or advanced rheumatoid arthritis.
  • •Participation in any rehabilitation program during the study period.

研究组 & 干预措施

virtual reality

Experimental

Participants in this group will perform hand exercises using virtual reality. They will complete task-oriented hand exercises resembling activities of daily living through the ErgoActive system, which consists of four different games.

干预措施: virtual reality (Behavioral)

Conventional treatment

Active Comparator

Participants in this group will perform exercises involving hand skills used in daily life. These exercises will be similar to those in the virtual reality group but will be carried out in their real-life form.

干预措施: Conventional treatment (Behavioral)

结局指标

主要结局

Activities of daily living (Duruöz Hand Index)

时间窗: before treatment, week 6

Cortical Hemodynamics (Functional Near-Infrared Spectroscopy)

时间窗: before treatment, week 6

Hand skills (Minnesota Manual Dexterity Test)

时间窗: before treatment, week 6

次要结局

  • Gross grip strength (Jamar hand dynamometer)(before treatment, week 6)
  • Determination of hand preference (Edinburgh Handedness Inventory)(before treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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