The Impact of Multi-Touch Functional Digital Game on Intelligence and Vitality for the Community-dwelling Elderly
20. September 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
32
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Seoul, Korea, Republik von, 06351
- Samsung Medical Center
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
65 Jahre bis 84 Jahre (Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
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)
|
|
Experimental: 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.
|
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)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from baseline performance on Stroop test (Neuropsychological test) after the intervention (Day 13).
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from baseline performance on Fluency Test (Neuropsychological test) after the intervention (Day 13).
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: 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)
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: 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.
Zeitfenster: 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).
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
16. September 2021
Primärer Abschluss (Tatsächlich)
21. Februar 2022
Studienabschluss (Tatsächlich)
4. August 2022
Studienanmeldedaten
Zuerst eingereicht
5. April 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. Mai 2021
Zuerst gepostet (Tatsächlich)
5. Mai 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. September 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. September 2022
Zuletzt verifiziert
1. April 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2021-03-011
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .