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

Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05472415
Collaborator
(none)
40
1
2
5.2
7.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: cognicise
  • Device: arch support insoles
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Cognicise and Arch Support Insoles on Lower-extremity Function in Community-dwelling Older Adults With Mild Cognitive Impairment
Anticipated Study Start Date :
Jul 25, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change of static standing balance [at baseline and after 12-wk of intervention]

    30-s static standing balance

  2. Change of timed-up-and-go test [at baseline and after 12-wk of intervention]

    3-m timed-up-and-go test

  3. Change of 10-m obstacle crossing [at baseline and after 12-wk of intervention]

    10-m obstacle crossing

  4. Change of functional reach test [at baseline and after 12-wk of intervention]

    functional reach test

  5. Change of Short Physical Performance Battery [at baseline and after 12-wk of intervention]

    Short Physical Performance Battery

  6. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cheng Hsin General Hospital Taipei Taiwan

Sponsors and Collaborators

  • National Taipei University of Nursing and Health Sciences

Investigators

  • Principal Investigator: Chen-Yi Song, National Taipei University of Nursing and Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CY Song, Associate professor, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier:
NCT05472415
Other Study ID Numbers:
  • 110A-37
First Posted:
Jul 25, 2022
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2022