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

Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05470062
Collaborator
(none)
40
1
2
6
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: arch support insoles (FootDisc)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Arch Support Insoles on Balance and Gait Performance in Older Adults With Mild Cognitive Impairment
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

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

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

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

  1. Change of static standing balance [at baseline and after 2-wk and 4-wk of insole wear]

    30-s static standing balance

  2. 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

  3. Change of 10-m obstacle crossing [at baseline and after 2-wk and 4-wk of insole wear]

    10-m obstacle crossing

  4. Change of functional reach test [at baseline and after 2-wk and 4-wk of insole wear]

    functional reach test

  5. Change of Short Physical Performance Battery [at baseline and after 2-wk and 4-wk of insole wear]

    Short Physical Performance Battery

  6. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cardinal Tien Hospital New Taipei City Taiwan

Sponsors and Collaborators

  • National Taipei University of Nursing and Health Sciences

Investigators

  • Principal Investigator: Chen-Yi Song, National Taipei University of Nursing and Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CY Song, Associate professor, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier:
NCT05470062
Other Study ID Numbers:
  • CTH-110-2-5-018
First Posted:
Jul 22, 2022
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022