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

NCT05472415 | Unknown

• 1 other identifier: 110A-37
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

cognicise training with insole intervention

Other: cognicise; Device: arch support insoles

control group

ACTIVE COMPARATOR

cognicise training

Other: cognicise

Interventions

cognicise OTHER

a combination of "cognition" and "exercise" training

control group; experimental group

arch support insoles DEVICE

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

experimental group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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).

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Cheng Hsin General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chen-Yi Song

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen-Yi Song

CONTACT

+886-2-28227101; cysong@ntunhs.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: July 25, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

TW (1)