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Completed

NCT Number: NCT04873843

The Impact of Multi-Touch Functional Digital Game on Intelligence and Vitality for the Community-dwelling Elderly

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.

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Key information

Conditions

Aging

Age range

65 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

At the first visit, the subjects are fully informed of the study if appropriate after determining whether they meet the selection criteria. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Functional digital game training group

Behavioral

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)

Individual cognitive training

Behavioral

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)

Primary outcomes

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

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: Baseline, After the intervention (Day 13)

    This is a generative naming test. That measure how many words you can spontaneously speak within a limited time of words that fall into a specific category (e.g. animals, store goods, vegetables) or words starting with a letter (e.g. F • A • S or C·F·L).

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

    Time frame: Baseline, After the intervention (Day 13)

    It consists of type A and type B trials. The participant should connect the numbers (1~25) as quickly as possible in Type A trial, and connect the numbers (1~13) and alphabets (A~L) alternatively as quickly as possible in type B trial. The main scores produced in this test are completion time and errors. Higher score means worse performance.

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

    Time frame: Baseline, After the intervention (Day 13)

    It measures auditory attention span and includes forward and backward trials. The participant listens to a series of numbers and calls the sequence correctly. The sequence increases in each trial. The final score is the longest number of sequential digits that the participant can remember correctly. The scores range from 3 to 8. The higher the score, the better the performance.

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

    Time frame: Baseline, After the intervention (Day 13)

    It measures participant's verbal memory. The participant will hear 15 words and recall them immediately and after 20 minutes again. The main scores produced in this test are the numbers of recalled words of the immediate and delayed trials. Immediate memory score is the sum of 5 trial's correct response and score ranges between 0 and 60. Delayed memory score is the correct response of the delayed trial and the score range is 0 to 15. Higher score means better performance.

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

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

    It measures brain activity during cognitive tasks to see if cognitive training affects brain function.

  6. Change from baseline activity on Contrasting Program/Go-No-Go test after the intervention (Day 13).

    Time frame: Baseline, Day 13(After the intervention)

    The Contrasting Program and go-no go test requires a subject to emit a simple motor response to one cue while inhibiting the response in the presence of another cue. This test has been effective in demonstrating impulsivity (elevated commission error rate) in elderly with attention deficit.

  7. Change from baseline activity on Geriatric Depression Scale (GDS) after the intervention (Day 13).

    Time frame: Baseline, After the intervention (Day 13)

    GDS is a 15-item self-report assessment used to identify depression in the elderly. A score of 0 to 5 is normal. A score greater than 5 suggests depression

  8. Change from baseline activity on health-related quality of life instrument with 20 items (HINT-20) after the intervention (Day 13).

    Time frame: Baseline, After the intervention (Day 13)

    The total score of the HINT-20 is converted to a 0-100 scale, with higher scores indicating better health-related quality of life.

  9. Change from baseline activity on General Self-Efficacy Scale (GSE) after the intervention (Day 13).

    Time frame: Baseline, After the intervention (Day 13)

    General self-efficacy (GSE), individuals'belief in their ability to perform well in a variety of situations. General self-efficacy (GSE) is the belief in one's competence to attempt difficult or novel tasks, and to cope with adversity arising from specific demanding situations.

  10. Change from baseline activity on International Physical Activity Questionnaire after the intervention (Day 13).

    Time frame: Baseline, After the intervention (Day 13)

    Physical Activity Questionnaire collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour, comprising 16 questions.

  11. User Satisfaction Questionnaire after intervention.

    Time frame: After the intervention (Day 13)

    We evaluate the satisfaction questionnaire for each training.

  12. Change from baseline activity on smart band activity through intervention completion(Day 12).

    Time frame: Baseline, through intervention completion(Day 12)

    Each participant was given an smart band(number of steps count) and instructed to wear it on the wrist during waking hours until completion of the training program. This included both intervening training days (totaling 10).

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 5, 2021
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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