Arch Support Effects on Balance and Gait in Older Adults With Mild Cognitive Impairment

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Arch Support Insoles on Balance and Gait Performance in Older Adults With Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Device: arch support insoles (FootDisc)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (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. Exclusion Criteria: (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).

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>wear the insoles for at least 4-h every day for 1-month | Device: arch support insoles (FootDisc)<br>* The FootDisc insole is designed with curEVA for shock absorption and motion reduction, poron for secondary heel and metatarsal protection, and dynamic arch support for returning energy for propulsion<br>|
| No Intervention: control group<br>not wear insoles for at least 4-h every day for 1-month | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of static standing balance | 30-s static standing balance | at baseline and after 2-wk and 4-wk of insole wear | 
| Change of timed-up-and-go test | 3-m timed-up-and-go test | at baseline and after 2-wk and 4-wk of insole wear | 
| Change of 10-m obstacle crossing | 10-m obstacle crossing | at baseline and after 2-wk and 4-wk of insole wear | 
| Change of functional reach test | functional reach test | at baseline and after 2-wk and 4-wk of insole wear | 
| Change of Short Physical Performance Battery | Short Physical Performance Battery | at baseline and after 2-wk and 4-wk of insole wear | 
| Change of gait | 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) | at baseline and after 2-wk and 4-wk of insole wear |