A Lego Robot Programming Intervention for Enhancing Older Adult Cognitive Health

The population in Taiwan is rapidly aging with an increasing proportion of older persons who experience cognitive difficulties but are otherwise physically healthy. As such there is a critical and urgent need for effective interventions to enhance older adult cognitive health. This present sub-project is part of the larger integrated project that will address this need by conducting cognitive training interventions on community older adults using the National Taiwan Science Education Center (NTSEC) as the public engagement window and collecting research behavioral and neurophysiological data to empirically and objectively examine intervention efficacies. In this sub-project, the investigators implement a clinical trial to evaluate an open-ended, flexible cognitive training intervention in middle to older adults aged 50 yrs or above using a 12-week Lego Robot Programming (Lego RP) protocol developed in the investigators' lab at the Graduate Institute of Brain and Mind Sciences, College of Medicine, National Taiwan University. The Lego RP training requires participants to generate and update abstract mental hypotheses of the effect of program codes on the physical actions of a robot based on how the robot behaves. Such mental processing is thought to drive flexible coordination between neural processes in the brain and benefit a broad range of cognitive abilities in older adults. The investigators target to obtain pre- and post-intervention behavioral and neurophysiological data (including brain imaging indicators) in 40 experimental participants, 40 active control participants, and 40 passive control participants over a period of 3 years.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Inferential Ability
• Intervention / Treatment: Behavioral: Lego Robot Programming Active Challenges; Behavioral: Lego Robot Programming Procedural Methods; Behavioral: Board Games

Detailed Description

The population in Taiwan is rapidly aging with an increasing proportion of older persons who experience cognitive difficulties but are otherwise physically healthy. As such there is a critical and urgent need for effective interventions to enhance older adult cognitive health. This present sub-project is part of the larger integrated project that will address this need by conducting cognitive training interventions on community older adults using the National Taiwan Science Education Center (NTSEC) as the public engagement window and collecting research behavioral and neurophysiological data to empirically and objectively examine intervention efficacies. In this sub-project, the investigators implement a clinical trial to evaluate an open-ended, flexible cognitive training intervention in middle to older adults aged 50 yrs or above using a 12-week Lego Robot Programming (Lego RP) protocol developed in the investigators' lab at the Graduate Institute of Brain and Mind Sciences, College of Medicine, National Taiwan University. The Lego RP training requires participants to generate and update abstract mental hypotheses of the effect of program codes on the physical actions of a robot based on how the robot behaves. Such mental processing is thought to drive flexible coordination between neural processes in the brain and benefit a broad range of cognitive abilities in older adults. The investigators target to obtain pre- and post-intervention behavioral and neurophysiological data (including brain imaging indicators) in 40 experimental participants, 40 active control participants, and 40 passive control participants over a period of 3 years. The investigators will also coordinate with the other sub-projects to assign participants to the different interventions involved as well as research data collection, which is shared. In contrast to previous studies of older adult cognitive training, the investigators expect this present approach, which leverages neurocognitive principles, to result in notable transfer between different cognitive abilities, and meaningful impact on daily functioning. The NTSEC recently seeks to engage the public, particularly children and older adults in STEAM education (Science, Technology, Engineering, Arts, Mathematics) to inspire and equip the population with the spirit of learning, discovery, and challenge-seeking, which is thought to raise mental resilience. Thus, the investigators' public outreach and research goals are highly complementary and the work is expected to yield more ecologically valid research data on a novel class of cognitive interventions for cognitive aging using psychological and brain imaging techniques to bridge critical neural mechanistic knowledge gaps. In addition, the research study will apply real public education benefits in society for those approximately 300 older participants who will participate in this study.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua OS Goh, Ph. D.; Phone Number: 88022 (+886)2-2312-3456; Email: joshuagoh@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 10051
    • Recruiting
    • college of Medicine, National Taiwan University
    • Contact: Ya-Ting Chang, M. Sc.; Phone Number: +886-2-2321-9581; Email: ntubmlab@gmail.com
  • Taipei, Taiwan, 11165
    • Recruiting
    • National Taiwan Science Education Center
    • Contact: Yi-Hsuan Lin; Phone Number: 5670 +886-2-6610-1234; Email: sha79417.ntsec@gmail.com
    • Sub-Investigator: Joshua OS Goh, Ph. D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Literate in Mandarin and Taiwanese
• Willing and able to participate in this research protocol in its entirety.
• Age >50

Exclusion Criteria:

• Participated in cognitive-related training in the past two months.
• Diagnosed with mild cognitive impairment (MCI)
• Severe psychological or behavioral disorder that would seriously interfere with the progress of activity
• History of degenerative cognitive disorder.
• Counter-indications for MRI scanning.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Problem-Solving Training; Participants will learn to program LEGO robots and will be encouraged to actively solve problems.	Behavioral: Lego Robot Programming Active Challenges; Participants will adapt their own Lego robot programs to achieve specific task goals.; Behavioral: Lego Robot Programming Procedural Methods; Participating will undergo Lego robot programming training that engages them to follow fixed programming coding steps.
Active Comparator: Step-By-Step Training; Participants will learn to program LEGO robots and will be instructed step by step.	Behavioral: Lego Robot Programming Procedural Methods; Participating will undergo Lego robot programming training that engages them to follow fixed programming coding steps.
Placebo Comparator: Board Games; Participants will play boards games under a schedule matching the Experimental and Active Comparator arms.	Behavioral: Board Games; Participants will play board games with each other.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of neural functional activity during inferential processing	Participants will undergo a Rule Inference fMRI task to infer underlying rules that map color configurations of circles in a triangular arrangement to a target color category within as few tries as possible under active or passive conditions. The goal for participants will be to infer the cue-category association rules using as few cues as possible. The primary outcome measure here is the degree of neural response estimate change in blood oxygen level dependent (BOLD) signal pre- and post-intervention.	Week 0, Week 12
Changes of overall accuracy during inferential processing	Changes from pre- to post-intervention in participant overall accuracy in identifying latent rules in the Rule Inference fMRI task.	Week 0, Week 12
Changes of learning rate during inferential processing	Changes from pre- to post-intervention in participant number of trials to criterion in the Rule Inference fMRI task.	Week 0, Week 12
Changes of strategic performance during inferential processing	Changes from pre- to post-intervention in participant coefficients of expression of modeled response strategies in the Rule Inference fMRI task will be assessed.	Week 0, Week 12
Changes in the Montreal Cognitive Assessment (MoCA) score	Pre- to post-intervention changes in participant MoCA score. Score range from 0 to 30 with higher scores indicating better cognitive ability.	Week 0, Week 12
Change in Wechsler Memory Scale III Logical Memory I & II	Score range 0 - 75. Higher score indicates better verbal episodic memory.	Week 0, Week 12
Change in Wechsler Memory Scale III Face Memory	Score range 0 - 48. Higher score indicates better visual face memory.	Week 0, Week 12
Change in Wechsler Memory Scale III Verbal Paired Memory	Score range 0 - 32. Higher score indicates better verbal memory and learning.	Week 0, Week 12
Change in Wechsler Memory Scale III Family Pictures I & II	Score range 0 - 64. Higher score indicates better visual memory and learning.	Week 0, Week 12
Change in Wechsler Memory Scale III Word Lists I & II	Score range 0 - 36. Higher score indicates better verbal memory and learning. For II, recall score range is 0 to 8; recognition score range is 0 to 24.	Week 0, Week 12
Change in Wechsler Memory Scale III Visual Reproduction I & II	Score range 0 - 104. Higher score indicates better visual memory. For II, recall score range is 0-104; recognition score range is 0-48.	Week 0, Week 12
Change in Wechsler Memory Scale III Spatial Span	Score range 0 - 32. Higher score indicates better spatial memory.	Week 0, Week 12
Change in Wechsler Memory Scale III Digit Span	Score range 0 - 32. Higher score indicates better auditory memory.	Week 0, Week 12
Change in Wechsler Adult Intelligence Scale III Vocabulary	Score range 0 - 66. Higher score indicates better vocabulary.	Week 0, Week 12
Change in Wechsler Adult Intelligence Scale III Digit Symbol	Score range 0 - 133. Higher score indicates better processing speed.	Week 0, Week 12
Change in Wechsler Adult Intelligence Scale III Block Design	Score range 0 - 68. Higher score indicates better visual processing.	Week 0, Week 12
Change in Wechsler Adult Intelligence Scale III Arithmetic	Score range 0 - 22. Higher score indicates better mathematical computation ability.	Week 0, Week 12
Change in Wechsler Adult Intelligence Scale III Matrix Reasoning	Score range 0 - 26. Higher score indicates better reasoning.	Week 0, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of neural functional activity during resting-state	Brain functional activity measured using fMRI during rest with eyes-open.	Week 0, Week 12

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Ministry of Science and Technology, Taiwan; National Taiwan University; National Taiwan Science Education Center
• Investigators: Principal Investigator: Joshua OS Goh, Ph. D., National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Aging; Clinical Trial; Brain Imaging; Cognitive Training Intervention; Lego Robot; Public Education; Psychological Testing
• Other Study ID Numbers: 202103148RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data that can be shared include anonymized neuropsychological assessment scores, cognitive behavioral performance scores, brain imaging data that have been published.
• IPD Sharing Time Frame: Data will become available 1 year after primary results are published by the central research team. Data are anticipated to be available for sharing for an indefinite period after the above criteria is met.
• IPD Sharing Access Criteria: Data sharing will be done based direct requests and on case-by-case evaluation for appropriateness. Use of shared data will require agreement on appropriate citation of data sources at least or authorship inclusion or acknowledgement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

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