Clinical trial NCT05470062: Arch Support Effects on Balance and Gait in Older Adults With Mild Cognitive Impairment
Official title: Effects of Arch Support Insoles on Balance and Gait Performance in Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change of static standing balance
timeFrame: at baseline and after 2-wk and 4-wk of insole wear
measure: Change of timed-up-and-go test
timeFrame: at baseline and after 2-wk and 4-wk of insole wear
measure: Change of 10-m obstacle crossing
timeFrame: at baseline and after 2-wk and 4-wk of insole wear
measure: Change of functional reach test
timeFrame: at baseline and after 2-wk and 4-wk of insole wear
measure: Change of Short Physical Performance Battery
timeFrame: at baseline and after 2-wk and 4-wk of insole wear
measure: Change of gait
timeFrame: at baseline and after 2-wk and 4-wk of insole wear
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Cardinal Tien Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Chen-Yi Song
role: PRINCIPAL_INVESTIGATOR
References: