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

NCT05470062 | Unknown DMC

• 1 other identifier: CTH-110-2-5-018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (6)

• Change of static standing balance

  30-s static standing balance

  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

  at baseline and after 2-wk and 4-wk of insole wear

• Change of 10-m obstacle crossing

  10-m obstacle crossing

  at baseline and after 2-wk and 4-wk of insole wear

• Change of functional reach test

  functional reach test

  at baseline and after 2-wk and 4-wk of insole wear

• Change of Short Physical Performance Battery

  Short Physical Performance Battery

  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)

  at baseline and after 2-wk and 4-wk of insole wear

Study Arms (2)

experimental group

EXPERIMENTAL

wear the insoles for at least 4-h every day for 1-month

Device: arch support insoles (FootDisc)

control group

NO INTERVENTION

not wear insoles for at least 4-h every day for 1-month

Interventions

arch support insoles (FootDisc) DEVICE

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

experimental group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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).

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Cardinal Tien Hospital

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chen-Yi Song

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen-Yi Song

CONTACT

+886-2-28227101; cysong@ntunhs.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 22, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

TW (1)