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

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: cognicise; Device: arch support insoles

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Cheng Hsin General Hospital
    • Contact: Wei Yuan; Phone Number: 886-2-2826-4400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: experimental group; cognicise training with insole 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
ACTIVE_COMPARATOR: control group; cognicise training	Other: cognicise; a combination of "cognition" and "exercise" training

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 25, 2022
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (ACTUAL): July 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 110A-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No