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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470062
• Other study ID #: CTH-110-2-5-018
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: National Taipei University of Nursing and Health Sciences
• Contact: Chen-Yi Song
• Phone: +886-2-28227101
• Email: cysong[@]ntunhs.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• arch 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

Locations

Country	Name	City	State
Taiwan	Cardinal Tien Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of static standing balance	30-s static standing balance	at baseline and after 2-wk and 4-wk of insole wear
Primary	Change of timed-up-and-go test	3-m timed-up-and-go test	at baseline and after 2-wk and 4-wk of insole wear
Primary	Change of 10-m obstacle crossing	10-m obstacle crossing	at baseline and after 2-wk and 4-wk of insole wear
Primary	Change of functional reach test	functional reach test	at baseline and after 2-wk and 4-wk of insole wear
Primary	Change of Short Physical Performance Battery	Short Physical Performance Battery	at baseline and after 2-wk and 4-wk of insole wear
Primary	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)	at baseline and after 2-wk and 4-wk of insole wear