Clinical trial NCT04873843: The Impact of Multi-Touch Functional Digital Game on Intelligence and Vitality for the Community-dwelling Elderly
Official title: The Impact of Multi-Touch Functional Digital Game on Intelligence and Vitality for the Community-dwelling Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Elderly
Functional Digital Game
Multi-touch Game
Intelligence
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline performance on Stroop test (Neuropsychological test) after the intervention (Day 13).
timeFrame: Baseline, After the intervention (Day 13)
Secondary outcomes:
measure: Change from baseline performance on Fluency Test (Neuropsychological test) after the intervention (Day 13).
timeFrame: Baseline, After the intervention (Day 13)
measure: Change from baseline performance on Trail Making Test (Neuropsychological test) after the intervention (Day 13).
timeFrame: Baseline, After the intervention (Day 13)
measure: Change from baseline performance on Digit Span Test (Neuropsychological test) after the intervention (Day 13).
timeFrame: Baseline, After the intervention (Day 13)
measure: Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) after the intervention (Day 13).
timeFrame: Baseline, After the intervention (Day 13)
measure: Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) during the intervention(Day 1 and 12)and after intervention completion(Day 12)
timeFrame: Baseline, during the intervention(Day 1 and 12), Through intervention completion(Day 12)
measure: Change from baseline activity on Contrasting Program/Go-No-Go test after the intervention (Day 13).
timeFrame: Baseline, Day 13(After the intervention)
measure: Change from baseline activity on Geriatric Depression Scale (GDS) after the intervention (Day 13).
timeFrame: Baseline, After the intervention (Day 13)
measure: Change from baseline activity on health-related quality of life instrument with 20 items (HINT-20) after the intervention (Day 13).
timeFrame: Baseline, After the intervention (Day 13)
measure: Change from baseline activity on General Self-Efficacy Scale (GSE) after the intervention (Day 13).
timeFrame: Baseline, After the intervention (Day 13)
measure: Change from baseline activity on International Physical Activity Questionnaire after the intervention (Day 13).
timeFrame: Baseline, After the intervention (Day 13)
measure: User Satisfaction Questionnaire after intervention.
timeFrame: After the intervention (Day 13)
measure: Change from baseline activity on smart band activity through intervention completion(Day 12).
timeFrame: Baseline, through intervention completion(Day 12)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-hee Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: