NCT04873843

Brief Summary

This single-blinded, randomized, controlled trial includes 32 elderly. The participants were randomized to intervention(Happy Table) and control(cognitive stimulation activity) groups. Each group is divided in 16 participants. In one session, participants in the Happy Table group completed 40 minutes of intervention using Happy Table serious game, whereas those in the Control group completed 40 minutes of cognitive stimulation game.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 16, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2022

Completed
Last Updated

September 22, 2022

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

April 5, 2021

Last Update Submit

September 20, 2022

Conditions

Keywords

ElderlyFunctional Digital GameMulti-touch GameIntelligence

Outcome Measures

Primary Outcomes (1)

  • Change from baseline performance on Stroop test (Neuropsychological test) after the intervention (Day 13).

    It measures a participant's processing speed, selective attention and inhibitory control. The participant will be asked to read 'word' of the colored words or 'name of the color' of the colored words in separate trials. The main scores produced in this test are completion time and errors. The contrast score of the two trial's completion time means interference.

    Baseline, After the intervention (Day 13)

Secondary Outcomes (12)

  • Change from baseline performance on Fluency Test (Neuropsychological test) after the intervention (Day 13).

    Baseline, After the intervention (Day 13)

  • Change from baseline performance on Trail Making Test (Neuropsychological test) after the intervention (Day 13).

    Baseline, After the intervention (Day 13)

  • Change from baseline performance on Digit Span Test (Neuropsychological test) after the intervention (Day 13).

    Baseline, After the intervention (Day 13)

  • Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) after the intervention (Day 13).

    Baseline, After the intervention (Day 13)

  • Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) during the intervention(Day 1 and 12)and after intervention completion(Day 12)

    Baseline, during the intervention(Day 1 and 12), Through intervention completion(Day 12)

  • +7 more secondary outcomes

Study Arms (2)

Functional digital game training group

EXPERIMENTAL

These functional digital game programs have been developed to improve the intelligence and vitality in the community-dwelling elderly. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty.

Behavioral: Functional digital game training group

Individual cognitive training

EXPERIMENTAL

Individual cognitive training has been used to improve the intelligence and cognitive function in community-dwelling elderly. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty.

Behavioral: Individual cognitive training

Interventions

Functional digital game training group is divided in 16 participants. In one session, participants in the functional digital game training group completed 40 minutes of intervention using various functional digital game such as working memory, memory, and attention. (Total 10 session)

Functional digital game training group

Functional digital game training group is divided in 16 participants. In one session, participants in the individual cognitive training group completed 40 minutes of intervention using various cognitive training such as working memory, memory, and attention. (Total 10 session)

Individual cognitive training

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • community-dwelling senior citizens aged 65 to 84
  • Those without a history of central nervous system(CNS) disease

You may not qualify if:

  • When it is difficult to understand the task performance due to severe cognitive decline(Korean Simple Mental State Test, K-MMSE 10 points or less).
  • When it is difficult to use this game device due to problems such as decreased vision or fracture of the upper limb
  • In case of accompanying serious mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Study Officials

  • Yun-hee Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2021

First Posted

May 5, 2021

Study Start

September 16, 2021

Primary Completion

February 21, 2022

Study Completion

August 4, 2022

Last Updated

September 22, 2022

Record last verified: 2021-04

Locations