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

20. září 2022 aktualizováno: Samsung Medical Center
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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

32

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

65 let až 84 let (Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Functional digital game training group
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.
Behaviorální: Functional digital game training group
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)
Experimentální: Individual cognitive training
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.
Behaviorální: Individual cognitive training
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)

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline performance on Stroop test (Neuropsychological test) after the intervention (Day 13).
Časové okno: 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.
Baseline, After the intervention (Day 13)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline performance on Fluency Test (Neuropsychological test) after the intervention (Day 13).
Časové okno: 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).
Baseline, After the intervention (Day 13)
Change from baseline performance on Trail Making Test (Neuropsychological test) after the intervention (Day 13).
Časové okno: 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.
Baseline, After the intervention (Day 13)
Change from baseline performance on Digit Span Test (Neuropsychological test) after the intervention (Day 13).
Časové okno: 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.
Baseline, After the intervention (Day 13)
Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) after the intervention (Day 13).
Časové okno: 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.
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)
Časové okno: 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.
Baseline, during the intervention(Day 1 and 12), Through intervention completion(Day 12)
Change from baseline activity on Contrasting Program/Go-No-Go test after the intervention (Day 13).
Časové okno: 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.
Baseline, Day 13(After the intervention)
Change from baseline activity on Geriatric Depression Scale (GDS) after the intervention (Day 13).
Časové okno: 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
Baseline, After the intervention (Day 13)
Change from baseline activity on health-related quality of life instrument with 20 items (HINT-20) after the intervention (Day 13).
Časové okno: 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.
Baseline, After the intervention (Day 13)
Change from baseline activity on General Self-Efficacy Scale (GSE) after the intervention (Day 13).
Časové okno: 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.
Baseline, After the intervention (Day 13)
Change from baseline activity on International Physical Activity Questionnaire after the intervention (Day 13).
Časové okno: 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.
Baseline, After the intervention (Day 13)
User Satisfaction Questionnaire after intervention.
Časové okno: After the intervention (Day 13)
We evaluate the satisfaction questionnaire for each training.
After the intervention (Day 13)
Change from baseline activity on smart band activity through intervention completion(Day 12).
Časové okno: 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).
Baseline, through intervention completion(Day 12)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Samsung Medical Center

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

16. září 2021

Primární dokončení (Aktuální)

21. února 2022

Dokončení studie (Aktuální)

4. srpna 2022

Termíny zápisu do studia

První předloženo

5. dubna 2021

První předloženo, které splnilo kritéria kontroly kvality

4. května 2021

První zveřejněno (Aktuální)

5. května 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. září 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. září 2022

Naposledy ověřeno

1. dubna 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 2021-03-011

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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