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临床试验/NCT05472415
NCT05472415Unknown不适用

Effects of Cognicise and Arch Support Insoles on Lower-extremity Function in Community-dwelling Older Adults With Mild Cognitive Impairment

National Taipei University of Nursing and Health Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年7月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Change of static standing balance

研究概览

简要总结

The purpose of this study aims to explore the surplus effect of arch support insole to a cognicise training program on lower-extremity function in community-dwelling older adults with mild cognitive impairment (MCI). In this randomized controlled intervention study, we will recruit 40 community-dwelling individuals aged ≥55 years with MCI. Experimental group (n=20) will receive cognicise training program with insole intervention (6 hours/day), while the control group (n=20) only undergo cognicise training. A 1-h training session will be given three times a week for 12 weeks for both groups. The outcomes include static standing balance, functional reach test, timed-up-and-go test, 10-m obstacle crossing, the Short Physical Performance Battery (SPPB), and gait assessment during single- and dual-task walking for 20 m at self-selected comfortable pace while performing serial subtractions (cognitive interference) or carrying a tray (motor interference). The results of the current study are expected to provide evidences in supporting the use of arch support insole among community-dwelling older adults with MCI. Interventions combing physical-cognitive training and insole for providing mechanical stability and somatosensory stimulation may serve as potential strategies for fall prevention.

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
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) aged 55 years and over; (2) able to walk more than 20 m without walking aids; (3) had a Montreal Cognitive Assessment (MoCA) score lower than 26 ; (4) had self-reported memory complaints; and (5) had the ability to perform ADLs.

排除标准

  • (1) dementia; (2) a history of malignant tumors ; (3) the presence of an unstable neurological or orthopedic disease, or visual problems interfering with participation in the study; and (4) an education level less than 6 years (elementary school).

结局指标

主要结局

Change of static standing balance

时间窗: at baseline and after 12-wk of intervention

30-s static standing balance

Change of functional reach test

时间窗: at baseline and after 12-wk of intervention

functional reach test

Change of Short Physical Performance Battery

时间窗: at baseline and after 12-wk of intervention

Short Physical Performance Battery

Change of timed-up-and-go test

时间窗: at baseline and after 12-wk of intervention

3-m timed-up-and-go test

Change of gait

时间窗: at baseline and after 12-wk of intervention

single- and dual-task walking for 20 m at self-selected comfortable pace while performing serial subtractions (cognitive interference) or carrying a tray (motor interference)

Change of 10-m obstacle crossing

时间窗: at baseline and after 12-wk of intervention

10-m obstacle crossing

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

CY Song

Associate professor

National Taipei University of Nursing and Health Sciences

研究点 (1)

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