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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472415
• Other study ID #: 110A-37
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: National Taipei University of Nursing and Health Sciences
• Contact: Chen-Yi Song
• Phone: +886-2-28227101
• Email: cysong[@]ntunhs.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• cognicise
a combination of "cognition" and "exercise" training

Device:
• arch 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

Locations

Country	Name	City	State
Taiwan	Cheng Hsin General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of static standing balance	30-s static standing balance	at baseline and after 12-wk of intervention
Primary	Change of timed-up-and-go test	3-m timed-up-and-go test	at baseline and after 12-wk of intervention
Primary	Change of 10-m obstacle crossing	10-m obstacle crossing	at baseline and after 12-wk of intervention
Primary	Change of functional reach test	functional reach test	at baseline and after 12-wk of intervention
Primary	Change of Short Physical Performance Battery	Short Physical Performance Battery	at baseline and after 12-wk of intervention
Primary	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)	at baseline and after 12-wk of intervention