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

20 september 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

32

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar tot 84 jaar (Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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)
Experimenteel: 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.
Gedragsmatig: 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)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline performance on Stroop test (Neuropsychological test) after the intervention (Day 13).
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline performance on Fluency Test (Neuropsychological test) after the intervention (Day 13).
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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)
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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.
Tijdsspanne: 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).
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Samsung Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 september 2021

Primaire voltooiing (Werkelijk)

21 februari 2022

Studie voltooiing (Werkelijk)

4 augustus 2022

Studieregistratiedata

Eerst ingediend

5 april 2021

Eerst ingediend dat voldeed aan de QC-criteria

4 mei 2021

Eerst geplaatst (Werkelijk)

5 mei 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 september 2022

Laatste update ingediend die voldeed aan QC-criteria

20 september 2022

Laatst geverifieerd

1 april 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 2021-03-011

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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