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临床试验/NCT05470062
NCT05470062Unknown不适用

Effects of Arch Support Insoles on Balance and Gait Performance in 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1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 10-m obstacle crossing

研究概览

简要总结

This study aims to explore the effects of arch support insoles on balance and gait performance in older adults with mild cognitive impairment (MCI). We will recruit 40 female older adults with MCI. A randomized crossover trial will be used to determine the immediate effect of arch support insoles. All participants received one assessment session wearing and one session not wearing insole in a random order within 1-day. Then participants will be randomly allocated to experimental group (arch support insoles, n=20) or control group (no insoles, n=20) for at least 4-h every day for 1-month. Our primary outcomes include static standing balance, timed-up-and-go test, 10-m obstacle crossing, functional reach test, 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). Assessments will be conducted at baseline and after 2-wk and 4-wk of insole wear. Statistical analyses will be performed using SPSS 21.0 software. Two-way mixed ANOVA will be used to determine the immediate and short- and long-term effect of arch support insoles. The results of the current study are expected to provide evidences in supporting the use of arch support insoles for improving gait performance and postural stability for older adults with MCI which will contribute to balance and gait training as well as 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
65 Years 至 80 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • (1) female aged 65 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 10-m obstacle crossing

时间窗: at baseline and after 2-wk and 4-wk of insole wear

10-m obstacle crossing

Change of gait

时间窗: at baseline and after 2-wk and 4-wk of insole wear

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 static standing balance

时间窗: at baseline and after 2-wk and 4-wk of insole wear

30-s static standing balance

Change of timed-up-and-go test

时间窗: at baseline and after 2-wk and 4-wk of insole wear

3-m timed-up-and-go test

Change of functional reach test

时间窗: at baseline and after 2-wk and 4-wk of insole wear

functional reach test

Change of Short Physical Performance Battery

时间窗: at baseline and after 2-wk and 4-wk of insole wear

Short Physical Performance Battery

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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