A Lego Robot Programming Intervention for Enhancing Older Adult Cognitive Health

NCT05341232 | Completed

• 1 other identifier: 202103148RINC
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cognitive Inferential Ability

Keywords

Aging; Cognitive Training Intervention; Lego Robot; Clinical Trial; Public Education; Psychological Testing; Brain Imaging

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (1)

• Changes of neural functional activity during resting-state

  Week 0, Week 12

Study Arms (3)

Problem-Solving Training

EXPERIMENTAL

Participants will learn to program LEGO robots and will be encouraged to actively solve problems.

Behavioral: Lego Robot Programming Active Challenges; Behavioral: Lego Robot Programming Procedural Methods

Step-By-Step Training

ACTIVE COMPARATOR

Participants will learn to program LEGO robots and will be instructed step by step.

Behavioral: Lego Robot Programming Procedural Methods

Board Games

PLACEBO COMPARATOR

Participants will play boards games under a schedule matching the Experimental and Active Comparator arms.

Behavioral: Board Games

Interventions

Board Games BEHAVIORAL

Participants will play board games with each other.

Board Games

Lego Robot Programming Active Challenges BEHAVIORAL

Participants will adapt their own Lego robot programs to achieve specific task goals.

Problem-Solving Training

Lego Robot Programming Procedural Methods BEHAVIORAL

Participating will undergo Lego robot programming training that engages them to follow fixed programming coding steps.

Problem-Solving Training; Step-By-Step Training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Literate in Mandarin and Taiwanese
• Willing and able to participate in this research protocol in its entirety.
• Age \>65

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator
• National Taiwan University: collaborator
• National Taiwan Science Education Center: collaborator

Study Sites (2)

College of Medicine, National Taiwan University

Taipei, 10051, Taiwan

Location

National Taiwan Science Education Center

Taipei, 11165, Taiwan

Location

Study Officials

• Joshua OS Goh, Ph. D.

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 22, 2022
• Study Start: September 1, 2021
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: February 5, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.

Locations

TW (2)