Effects of Arch Support Insoles on Balance and Gait Performance in Older Adults With Mild Cognitive Impairment
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
- 否
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
CY Song
Associate professor
National Taipei University of Nursing and Health Sciences
