- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03940079
Efficacy of Computer-Based Cognitive Game Training for Healthy Elderly
Efficacy of Computer-Based Cognitive Game Training on Motor and Cognitive Functions for Healthy Elderly
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Quasi-experimental design was adapted in our research.There are four time-series assessments during the experiment: baseline, pretest, posttest, and follow-up. After the baseline assessment, participants were randomized to two groups: gross-motor group (GMG) and fine-motor group (FMG). The intervals between baseline and pretest as well as between pretest and posttest were both 4 weeks, while the interval between posttest and follow-up was 8 weeks.
The investigators developed a computer-based cognitive game and compared the efficacy of cognitive and motor functions between computer-based cognitive game combining two different demands on motor control. Investigators hypothesized: All participants who take part in the computer-based cognitive game training don't have learning effects on pretest and are able to improve cognitive functions including short-term memory, divided attention and inhibitory function after intervention; Gross-motor group make more progress than fine-motor group on cognitive and motor functions after intervention. Furthermore, gross-motor group maintained more training effect over cognitive and motor functions at follow-up than fine-motor group.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Taipei, Taïwan, 100
- National Taiwan University Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- ≥ 65 years old
- Montreal Cognitive Assessment (MoCA) score ≥ 18
- clear eyesight and hearing
- both upper and lower limbs are functional
- normal communication
Exclusion Criteria:
- injury, fracture, and breathing problem
- surgery during the research
- severe disease affecting cognitive functions.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: gross-motor group (GMG)
The participants of GMG received motor-cognitive dual-task training. The sensors used by the participants were four different colored buttons. The participants wear a suit with two buttons on the shoulders and the other two fasten on the knees by velcros. To accomplish the tasks, the participants had to slap the correct colored buttons. The stretching of upper or lower limbs was demanding while slapping, so the participants of GMG received a training which required cognitive and motor functions at the same time. The participants attended 2 sessions per week and lasted for 4 weeks. Each session lasted 75 minutes, mainly including 30 minutes for game introduction and warm-up, 30 minutes for game training, and 15 minutes for rest during the training. Each task lasted 10 minutes, and each session contained 3 tasks. The game difficulty could be adjusted automatically according to the performance of participants. |
First task was short-term memory training. Participants were instructed to memorize different colored circles with ordinal numbers which would disappear later. They triggered correct colored sensor in sequence according to their memory. Second task was divided attention training. Different colored circles with ordinal numbers would not disappear this time.The participants should trigger correct colored sensor according to their sequence. Third task was inhibitory function training. There were red and green lights, just like the traffic light, hung up at the upper left of the scene. Red light represented prohibition of triggering the colored sensor, while green light urged to trigger it. Yellow, red, blue and green circles showed up randomly and moved toward the beige region. When the circle came extremely closer to the beige region, the traffic light was randomized to lighten up red or green.The participants should judge and trigger the correct colored sensor. |
|
Comparateur actif: fine-motor group (FMG)
The participants of FMG received cognitive training only. Four colored sensors used by the participants were the keys on the keyboard of the laptop. The participants simply pressed correct colored keys by fingers to complete the tasks. The participants attended 2 sessions per week and lasted for 4 weeks. Each session lasted 75 minutes, mainly including 30 minutes for game introduction and warm-up, 30 minutes for game training, and 15 minutes for rest during the training. Each task lasted 10 minutes, and each session contained 3 tasks. The game difficulty could be adjusted automatically according to the performance of participants. |
First task was short-term memory training. Participants were instructed to memorize different colored circles with ordinal numbers which would disappear later. They triggered correct colored sensor in sequence according to their memory. Second task was divided attention training. Different colored circles with ordinal numbers would not disappear this time.The participants should trigger correct colored sensor according to their sequence. Third task was inhibitory function training. There were red and green lights, just like the traffic light, hung up at the upper left of the scene. Red light represented prohibition of triggering the colored sensor, while green light urged to trigger it. Yellow, red, blue and green circles showed up randomly and moved toward the beige region. When the circle came extremely closer to the beige region, the traffic light was randomized to lighten up red or green.The participants should judge and trigger the correct colored sensor. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 4th, 8th and 16th weeks
Délai: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
overall cognitive function
|
baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
|
Change from Baseline Digit Span Task-forward (DS-forward) at the 4th, 8th and 16th weeks
Délai: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
short-term memory
|
baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
|
Change from Baseline Color Trails Test-2 (CTT-2) at the 4th, 8th and 16th weeks
Délai: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
divided attention
|
baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
|
Change from Baseline Stroop Color Word Test (SCWT) at the 4th, 8th and 16th weeks
Délai: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
inhibitory function
|
baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
|
Change from Baseline Nine Hole Peg Test (NHPT) at the 4th, 8th and 16th weeks
Délai: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
motor function of upper limbs
|
baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
|
Change from Baseline Get-Up and Go Test (GUG) at the 4th, 8th and 16th weeks
Délai: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
motor function of lower limbs and balance
|
baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
|
Change from Baseline Five-Times-Sit-to-Stand Test (FTSST) at the 4th, 8th and 16th weeks
Délai: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
motor function of lower limbs and balance
|
baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from 4th weeks Game1 (first scenario) evaluated the performance of short-term memory at 8th weeks
Délai: 4th weeks pretest, 8th weeks posttest
|
Game assessment was a new way to evaluate cognitive performance of the participant through the score.
All participants proceeded all three scenarios but challenged same degree of difficulty.
|
4th weeks pretest, 8th weeks posttest
|
|
Change from 4th weeks Game2 (second scenario) evaluated divided attention at 8th weeks
Délai: 4th weeks pretest, 8th weeks posttest
|
Game assessment was a new way to evaluate cognitive performance of the participant through the score.
All participants proceeded all three scenarios but challenged same degree of difficulty.
|
4th weeks pretest, 8th weeks posttest
|
|
Change from 4th weeks Game3 (third scenario) evaluated inhibitory function at 8th weeks
Délai: 4th weeks pretest, 8th weeks posttest
|
Game assessment was a new way to evaluate cognitive performance of the participant through the score.
All participants proceeded all three scenarios but challenged same degree of difficulty.
|
4th weeks pretest, 8th weeks posttest
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Central Contact Backup Mao, National Taiwan University Hospital
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
Autres numéros d'identification d'étude
- 201804055RINC
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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