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

Not Applicable

• Conditions: Mild Cognitive Impairment
• Interventions: Other: cognicise; Device: arch support insoles

• Registration Number: NCT05472415
• Lead Sponsor: National Taipei University of Nursing and Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-21
• Last Update Submitted: 2022-07-21
• Study Start: 2022-07-25
• Study First Posted: 2022-07-25
• Last Update Posted: 2022-07-25
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	cognicise	cognicise training with insole intervention
experimental group	arch support insoles	cognicise training with insole intervention
control group	cognicise	cognicise training

Primary Outcome Measures

Name	Time	Method
Change of static standing balance	at baseline and after 12-wk of intervention	30-s static standing balance
Change of functional reach test	at baseline and after 12-wk of intervention	functional reach test
Change of Short Physical Performance Battery	at baseline and after 12-wk of intervention	Short Physical Performance Battery
Change of timed-up-and-go test	at baseline and after 12-wk of intervention	3-m timed-up-and-go test
Change of gait	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	at baseline and after 12-wk of intervention	10-m obstacle crossing

Trial Locations

Locations (1)

Cheng Hsin General Hospital; 🇨🇳 Taipei, Taiwan