Effects of Cognicise and Arch Support Insoles in Older Adults With Mild Cognitive Impairment

Study Overview
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Brief Summary
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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.

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Other: cognicise
* Device: arch support insoles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (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. 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: 55 Years

Sexes Eligible for Study
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All

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>cognicise training with insole intervention | Other: cognicise<br>* a combination of cognition and exercise training<br>Device: arch support insoles<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>|
| Active Comparator: control group<br>cognicise training | Other: cognicise<br>* a combination of cognition and exercise training<br>|

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 12-wk of intervention | 
| Change of timed-up-and-go test | 3-m timed-up-and-go test | at baseline and after 12-wk of intervention | 
| Change of 10-m obstacle crossing | 10-m obstacle crossing | at baseline and after 12-wk of intervention | 
| Change of functional reach test | functional reach test | at baseline and after 12-wk of intervention | 
| Change of Short Physical Performance Battery | Short Physical Performance Battery | at baseline and after 12-wk of intervention | 
| 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 12-wk of intervention |