Skip to main content
Clinical Trials/NCT05470062
NCT05470062
Unknown
Not Applicable

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

National Taipei University of Nursing and Health Sciences1 site in 1 country40 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
National Taipei University of Nursing and Health Sciences
Enrollment
40
Locations
1
Primary Endpoint
Change of 10-m obstacle crossing
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

CY Song

Associate professor

National Taipei University of Nursing and Health Sciences

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Change of 10-m obstacle crossing

Time Frame: at baseline and after 2-wk and 4-wk of insole wear

10-m obstacle crossing

Change of gait

Time Frame: 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

Time Frame: at baseline and after 2-wk and 4-wk of insole wear

30-s static standing balance

Change of timed-up-and-go test

Time Frame: at baseline and after 2-wk and 4-wk of insole wear

3-m timed-up-and-go test

Change of functional reach test

Time Frame: at baseline and after 2-wk and 4-wk of insole wear

functional reach test

Change of Short Physical Performance Battery

Time Frame: at baseline and after 2-wk and 4-wk of insole wear

Short Physical Performance Battery

Study Sites (1)

Loading locations...

Similar Trials