Mild Cognitive Impairment
Conditions
Brief summary
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.
Interventions
DEVICEarch support insoles (FootDisc)
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
Sponsors
National Taipei University of Nursing and Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of static standing balance | at baseline and after 2-wk and 4-wk of insole wear | 30-s static standing balance |
| Change of timed-up-and-go test | at baseline and after 2-wk and 4-wk of insole wear | 3-m timed-up-and-go test |
| Change of 10-m obstacle crossing | at baseline and after 2-wk and 4-wk of insole wear | 10-m obstacle crossing |
| Change of functional reach test | at baseline and after 2-wk and 4-wk of insole wear | functional reach test |
| Change of Short Physical Performance Battery | at baseline and after 2-wk and 4-wk of insole wear | Short Physical Performance Battery |
| Change of gait | 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) |
Countries
Taiwan
Contacts
Primary ContactChen-Yi Song
Outcome results
None listed