Arch Support Effects on Balance and Gait in Older Adults With Mild Cognitive Impairment
- Conditions
- Mild Cognitive Impairment
- Interventions
- Device: arch support insoles (FootDisc)
- Registration Number
- NCT05470062
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 40
- (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.
- (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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental group arch support insoles (FootDisc) wear the insoles for at least 4-h every day for 1-month
- Primary Outcome Measures
Name Time Method Change of 10-m obstacle crossing at baseline and after 2-wk and 4-wk of insole wear 10-m obstacle crossing
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)
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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cardinal Tien Hospital
🇨🇳New Taipei City, Taiwan