Arch Support Effects on Balance and Gait in Older Adults With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
arch support insoles (FootDisc)
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
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).
Sites / Locations
- Cardinal Tien HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental group
control group
Arm Description
wear the insoles for at least 4-h every day for 1-month
not wear insoles for at least 4-h every day for 1-month
Outcomes
Primary Outcome Measures
Change of static standing balance
30-s static standing balance
Change of timed-up-and-go test
3-m timed-up-and-go test
Change of 10-m obstacle crossing
10-m obstacle crossing
Change of functional reach test
functional reach test
Change of Short Physical Performance Battery
Short Physical Performance Battery
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05470062
First Posted
July 19, 2022
Last Updated
July 21, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05470062
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
wear the insoles for at least 4-h every day for 1-month
Arm Title
control group
Arm Type
No Intervention
Arm Description
not wear insoles for at least 4-h every day for 1-month
Intervention Type
Device
Intervention Name(s)
arch support insoles (FootDisc)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of static standing balance
Description
30-s static standing balance
Time Frame
at baseline and after 2-wk and 4-wk of insole wear
Title
Change of timed-up-and-go test
Description
3-m timed-up-and-go test
Time Frame
at baseline and after 2-wk and 4-wk of insole wear
Title
Change of 10-m obstacle crossing
Description
10-m obstacle crossing
Time Frame
at baseline and after 2-wk and 4-wk of insole wear
Title
Change of functional reach test
Description
functional reach test
Time Frame
at baseline and after 2-wk and 4-wk of insole wear
Title
Change of Short Physical Performance Battery
Description
Short Physical Performance Battery
Time Frame
at baseline and after 2-wk and 4-wk of insole wear
Title
Change of gait
Description
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)
Time Frame
at baseline and after 2-wk and 4-wk of insole wear
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen-Yi Song
Phone
+886-2-28227101
Ext
2410
Email
cysong@ntunhs.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen-Yi Song
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardinal Tien Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Chien Liu
Phone
886-2-22193391
Ext
66672
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Arch Support Effects on Balance and Gait in Older Adults With Mild Cognitive Impairment
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