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Clinical Trials/NCT05472415
NCT05472415
Unknown
Not Applicable

Effects of Cognicise and Arch Support Insoles on Lower-extremity Function in Community-dwelling Older Adults With Mild Cognitive Impairment

National Taipei University of Nursing and Health Sciences1 site in 1 country40 target enrollmentJuly 25, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
National Taipei University of Nursing and Health Sciences
Enrollment
40
Locations
1
Primary Endpoint
Change of static standing balance
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 25, 2022
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

CY Song

Associate professor

National Taipei University of Nursing and Health Sciences

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).

Outcomes

Primary Outcomes

Change of static standing balance

Time Frame: at baseline and after 12-wk of intervention

30-s static standing balance

Change of functional reach test

Time Frame: at baseline and after 12-wk of intervention

functional reach test

Change of Short Physical Performance Battery

Time Frame: at baseline and after 12-wk of intervention

Short Physical Performance Battery

Change of timed-up-and-go test

Time Frame: at baseline and after 12-wk of intervention

3-m timed-up-and-go test

Change of gait

Time Frame: at baseline and after 12-wk of intervention

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)

Change of 10-m obstacle crossing

Time Frame: at baseline and after 12-wk of intervention

10-m obstacle crossing

Study Sites (1)

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