- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Madrid
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Madrid, Madrid, Espagne, 28030
- Neurovida
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Experimental group
The experimental group will receive intervention through conventional videogames
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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. |
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Comparateur actif: Control group
Control group will receive a special talk about the uses of conventional videogames
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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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Montreal Cognitive Assessment (MoCA)
Délai: General perception of the person's cognitive sphere (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
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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.
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General perception of the person's cognitive sphere (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
|
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Observed Emotion Rating Scale (OERS)
Délai: 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)
|
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Menorah Park Engagement Scale (MPES)
Délai: 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.
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Pre-intervention and post-intervention (up to 1 week)
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Quality of Life in Alzheimer's Disease (QoL-AD, proxy version)
Délai: General perception of the person's recent overall wellbeing (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
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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.
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General perception of the person's recent overall wellbeing (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Cristina García Bravo, PhD, Universidad Rey Juan Carlos
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 100220261372026
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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