The Impact of Multi-Touch Functional Digital Game on Intelligence and Vitality for the Community-dwelling Elderly
1 other identifier
interventional
32
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
1 active site
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
CompletedFirst Posted
Study publicly available on registry
May 5, 2021
CompletedStudy Start
First participant enrolled
September 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2022
CompletedSeptember 22, 2022
April 1, 2021
5 months
April 5, 2021
September 20, 2022
Conditions
Keywords
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
EXPERIMENTALThese 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.
Individual cognitive training
EXPERIMENTALIndividual 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.
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 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)
Eligibility Criteria
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
Study Officials
- PRINCIPAL INVESTIGATOR
Yun-hee Kim, MD, PhD
Samsung Medical Center
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