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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05472415
Enrollment
40
Registered
2022-07-25
Start date
2022-07-25
Completion date
2022-12-31
Last updated
2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

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.

Interventions

OTHERcognicise

a combination of cognition and exercise training

DEVICEarch support insoles

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

Sponsors

National Taipei University of Nursing and Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change of static standing balanceat baseline and after 12-wk of intervention30-s static standing balance
Change of timed-up-and-go testat baseline and after 12-wk of intervention3-m timed-up-and-go test
Change of 10-m obstacle crossingat baseline and after 12-wk of intervention10-m obstacle crossing
Change of functional reach testat baseline and after 12-wk of interventionfunctional reach test
Change of Short Physical Performance Batteryat baseline and after 12-wk of interventionShort Physical Performance Battery
Change of gaitat baseline and after 12-wk of interventionsingle- and dual-task walking for 20 m at self-selected comfortable pace while performing serial subtractions (cognitive interference) or carrying a tray (motor interference)

Countries

Taiwan

Contacts

Primary ContactChen-Yi Song
cysong@ntunhs.edu.tw+886-2-28227101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026