- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07615647
How Video Game Therapy Affects Thinking and Emotions in Older Adults With Cognitive Impairment
COGNITIVE AND AFFECTIVE-MOTIVATIONAL EFFECTS OF A THERAPEUTIC INTERVENTION USING THE GOLDEN GAMERS METHODOLOGY IN OLDER ADULTS WITH COGNITIVE IMPAIRMENT
Golden Gamers Go is running a study together with Rey Juan Carlos University to better understand how videogames can help older adults, especially those with memory problems or cognitive decline.
The study takes place in real care settings, such as day centers, and involves around 45 older participants. Over two months (with a possible follow-up period), participants take part in two to three sessions per week using video games on PlayStation.
These are not special "health games," but popular, commercial video games that have been carefully selected and adapted to be easy to use, enjoyable, and meaningful for older adults.
The goal is to see whether playing these games can help improve thinking abilities and also how participants feel during the activity - for example, if they are more engaged, motivated, or emotionally positive.
This study builds on previous experience where this approach has already shown promising results in increasing participation, motivation, and overall wellbeing.
By carrying out this research, Golden Gamers Go aim to better understand how meaningful and enjoyable activities like videogames can support healthier and more active aging.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: ALEJANDRO MORILLAS TÉLLEZ, Master
- Numer telefonu: +34635268124
- E-mail: goldengamersmanagers@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Gloria Sánchez-Carnerero Casas
- E-mail: gsccto@gmail.com
Lokalizacje studiów
-
-
Madrid
-
Madrid, Madrid, Hiszpania, 28030
- Rekrutacyjny
- Neurovida
-
Kontakt:
- ALEJANDRO TÉLLEZ
- Numer telefonu: 635268124
- E-mail: morillasfhr@gmail.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Older adults with mild to moderate cognitive impairment, able to connect with their environment and participate in group or individual activities, and who agree to take part in the study.
Exclusion Criteria:
- Severe cognitive impairment with lack of environmental awareness, serious visual limitations that prevent interaction, or any condition causing distress or making participation unsafe.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Experimental group
The experimental group will receive intervention through conventional videogames
|
Therapy sessions are carried out in small groups using adapted comercial videogames. Each session begins with a simple introduction, followed by gameplay with continuous support. Participants can engage in different ways (playing, assisting, or observing), depending on their needs. Sessions end with a short group reflection, and professionals record participation and responses to guide future sessions. There a lot of unique aspects for this approach. First, the use of comercial videogames for therapy, instead of serious games. Therefore, the whole process is guided by the Golden Gamers Methodology, specialiced in cognitive accesibility. The combination of this kind of videogames, with this adaptations in a senior population with cognitive impairment is totally different from other studies. |
|
Aktywny komparator: Control group
Control group will receive a special talk about the uses of conventional videogames
|
This masterclass sessions are carried out in small groups. It talks about the use of certain videogames and VR devices for improving the health of the participants. Each session begins with a simple introduction, and end with a short group reflection, and professionals record participation and responses to guide future sessions. The vidoegames that will be described and shown for the users experience are some that have a high degree of accesibility from the Golden Gamers Methodology perspective.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
Ramy czasowe: General perception of the person's cognitive sphere (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
|
Measures overall cognitive function (memory, attention, language, orientation, etc.).
The total score ranges from 0 to 30 points.
Higher scores indicate better cognitive performance.
The standard administration guidance states that 26/30 or above is generally considered within the normal range, although cut-off points may vary depending on population, education level, age and clinical context.
|
General perception of the person's cognitive sphere (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
|
|
Observed Emotion Rating Scale (OERS)
Ramy czasowe: Pre-intervention and post-intervention (up to 1 week)
|
Measures emotional state during the sessions (positive and negative emotions observed).The OERS measures the intensity or duration of these affective states using a 5-point Likert-type scale. Each emotional state is rated separately, usually from 1 to 5. A higher score in pleasure is positive. A higher score in general alertness is usually positive or activation-related. Higher scores in anger, anxiety/fear or sadness indicate more negative affect. |
Pre-intervention and post-intervention (up to 1 week)
|
|
Menorah Park Engagement Scale (MPES)
Ramy czasowe: Pre-intervention and post-intervention (up to 1 week)
|
The adapted MPES assesses participant engagement during the activity using a 5-point duration scale aligned with the OERS.
Observation takes place during the central 10 minutes of the session, from minute 15 to minute 25, to avoid start-up or fatigue bias.
Each engagement category is scored according to the total accumulated time observed: 1 means the behaviour was never observed; 2 indicates a very brief occurrence; 3 indicates a short occurrence; 4 means the behaviour was observed for 1 to 5 minutes; and 5 means it was observed for more than 5 minutes.
The categories assessed are constructive engagement, passive engagement, social engagement, non-engagement and self-engagement.
If two behaviours occur at the same time, constructive engagement is prioritised.
|
Pre-intervention and post-intervention (up to 1 week)
|
|
Quality of Life in Alzheimer's Disease (QoL-AD, proxy version)
Ramy czasowe: General perception of the person's recent overall wellbeing (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
|
The QoL-AD proxy version assesses perceived quality of life in people with cognitive impairment through the judgement of a caregiver, professional or informant who knows the participant well.
It includes 13 items, each scored on a 4-point scale: 1 means poor, 2 means fair, 3 means good and 4 means excellent.
The total score is obtained by adding the 13 item scores, giving a possible range from 13 to 52 points.
Higher scores indicate better perceived quality of life.
|
General perception of the person's recent overall wellbeing (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
|
Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Cristina García Bravo, PhD, Universidad Rey Juan Carlos
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 100220261372026
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Upośledzenie funkcji poznawczych, łagodne
-
Atılım UniversityJeszcze nie rekrutacjaReformer Pilates Ćwiczenie, Cognitive Performans
-
Pamukkale UniversityRejestracja na zaproszenieOcena poznawcza | Elektrowstrząsy (ECT) | Ocena Poznawcza Terapii Elektrowstrząsowej (ECCA) | Montreal Cognitive Assessment (MoCA) | Turecka adaptacjaTurcja (Türkiye)
Badania kliniczne na Therapy with videogames
-
I.R.C.C.S. Fondazione Santa LuciaCampus Bio-Medico UniversityZakończonyUderzenie | Niedowład | Paraliż kończyn górnychWłochy
-
First Affiliated Hospital of Zhejiang UniversityRekrutacyjnyTNBC, potrójnie ujemny rak piersiChiny
-
The Hong Kong Polytechnic UniversityZakończonyUrządzenie nieskuteczneHongkong
-
Johnson & Johnson Vision Care, Inc.ZakończonyOstrość widzeniaStany Zjednoczone
-
Karadeniz Technical UniversityZakończonyHemodializa | Samotność | Szczęście | Dostosowanie | Terapia wspomagana przez zwierzęta | ObjawIndyk
-
ARCIM Institute Academic Research in Complementary...University Hospital TuebingenZakończony
-
Akdeniz UniversityJeszcze nie rekrutacjaOpieka pooperacyjna | Pacjenci chirurgii dziecięcejTurcja (Türkiye)
-
NYU Langone HealthDaisy FoundationJeszcze nie rekrutacjaToczeń rumieniowaty układowyStany Zjednoczone
-
Alaa Noureldeen KoraJeszcze nie rekrutacjaPierwotne bolesne miesiączkowanie | Otyłość i nadwagaEgipt
-
Karadeniz Technical UniversityRejestracja na zaproszenieBadanie wpływu terapii sztuki Mandala na objawy i jakość życia u pacjentów z stwardnieniem rozsianymStwardnienie rozsianeIndyk