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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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
Cardinal Tien Hospital
New Taipei City, Taiwan
RECRUITINGChange of static standing balance
30-s static standing balance
Time frame: 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
Time frame: at baseline and after 2-wk and 4-wk of insole wear
Change of 10-m obstacle crossing
10-m obstacle crossing
Time frame: at baseline and after 2-wk and 4-wk of insole wear
Change of functional reach test
functional reach test
Time frame: at baseline and after 2-wk and 4-wk of insole wear
Change of Short Physical Performance Battery
Short Physical Performance Battery
Time frame: 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)
Time frame: at baseline and after 2-wk and 4-wk of insole wear
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.