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Effects of Cognicise and Arch Support Insoles in Older Adults With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cognicise
arch support insoles
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (1) aged 55 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

  • Cheng Hsin General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

cognicise training with insole intervention

cognicise training

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

First Posted
July 21, 2022
Last Updated
July 21, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05472415
Brief Title
Effects of Cognicise and Arch Support Insoles in Older Adults With Mild Cognitive Impairment
Official Title
Effects of Cognicise and Arch Support Insoles on Lower-extremity Function in Community-dwelling 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 25, 2022 (Anticipated)
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
No

5. Study Description

Brief Summary
The purpose of this study aims to explore the surplus effect of arch support insole to a cognicise training program on lower-extremity function in community-dwelling older adults with mild cognitive impairment (MCI). In this randomized controlled intervention study, we will recruit 40 community-dwelling individuals aged ≥55 years with MCI. Experimental group (n=20) will receive cognicise training program with insole intervention (6 hours/day), while the control group (n=20) only undergo cognicise training. A 1-h training session will be given three times a week for 12 weeks for both groups. The outcomes include static standing balance, functional reach test, timed-up-and-go test, 10-m obstacle crossing, the 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). The results of the current study are expected to provide evidences in supporting the use of arch support insole among community-dwelling older adults with MCI. Interventions combing physical-cognitive training and insole for providing mechanical stability and somatosensory stimulation may serve as potential strategies for 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
cognicise training with insole intervention
Arm Title
control group
Arm Type
Active Comparator
Arm Description
cognicise training
Intervention Type
Other
Intervention Name(s)
cognicise
Intervention Description
a combination of "cognition" and "exercise" training
Intervention Type
Device
Intervention Name(s)
arch support insoles
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 12-wk of intervention
Title
Change of timed-up-and-go test
Description
3-m timed-up-and-go test
Time Frame
at baseline and after 12-wk of intervention
Title
Change of 10-m obstacle crossing
Description
10-m obstacle crossing
Time Frame
at baseline and after 12-wk of intervention
Title
Change of functional reach test
Description
functional reach test
Time Frame
at baseline and after 12-wk of intervention
Title
Change of Short Physical Performance Battery
Description
Short Physical Performance Battery
Time Frame
at baseline and after 12-wk of intervention
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 12-wk of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) aged 55 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
Cheng Hsin General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Yuan
Phone
886-2-2826-4400

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Cognicise and Arch Support Insoles in Older Adults With Mild Cognitive Impairment

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