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- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Taipei, Taiwán, 100
- National Taiwan University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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. |
Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 4th, 8th and 16th weeks
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
inhibitory function
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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
Periodo de tiempo: 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
Periodo de tiempo: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
|
motor function of lower limbs and balance
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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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from 4th weeks Game1 (first scenario) evaluated the performance of short-term memory at 8th weeks
Periodo de tiempo: 4th weeks pretest, 8th weeks posttest
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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
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Change from 4th weeks Game2 (second scenario) evaluated divided attention at 8th weeks
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Central Contact Backup Mao, National Taiwan University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 201804055RINC
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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