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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07895979
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
The goal of this clinical trial is to learn if a touchscreen-based virtual reality (VR) training program that simulates everyday life tasks works to improve daily living skills and thinking abilities in adults aged 50 and older, including those at risk of dementia (individuals with Subjective Cognitive Decline or Mild Cognitive Impairment). It will also explore what personal factors influence the training results. The main questions it aims to answer are:
- Does the daily life VR training program improve participants' ability to perform complex everyday activities and adapt flexibly to daily life challenges?
- Does the training improve overall thinking skills (such as memory, attention, and problem-solving), brain activity, and mood (depression and anxiety)? Researchers will compare the daily-life VR training program (IADL-VR) to a non-situational game VR program (Game-VR) and a traditional in-person tabletop cognitive training program (Cog-Entity) to see if realistic daily-life VR simulation works better to enhance everyday functioning and brain health.
Participants will:
- Be randomly assigned to one of the three training groups (daily-life VR tasks, digital brain-training mini-games, or traditional tabletop board games).
- Attend a 2-hour group session once a week for 12 weeks, which includes 1 hour of assigned cognitive training and 1 hour of physical fitness exercise.
- Complete assessments of their daily living skills, thinking abilities, mood, and brain activity (using functional magnetic resonance imaging, or fMRI) within 2 weeks before and after the 12-week program.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hui-Fen Mao
- Número de teléfono: 886-3366-8178
- Correo electrónico: huifen02@gmail.com
Ubicaciones de estudio
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Taipei, Taiwán
- Reclutamiento
- School of Occupational Therapy, College of Medicine, National Taiwan University
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Contacto:
- Hui-Fen Mao
- Número de teléfono: 886-3366-8178
- Correo electrónico: huifen02@gmail.com
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Investigador principal:
- Hsiao-Wen Chen
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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:
General Inclusion Criteria (Applicable to All Participants):
- Aged 50 years or older.
- Completed at least elementary school education (6 or more years of formal education) and able to read and write in Chinese.
Group-Specific Inclusion Criteria:
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Cognitively Healthy Middle-Aged and Older Adults Group:
- Taiwanese version of the Montreal Cognitive Assessment (MoCA) score > 26.
- Does not meet the diagnostic criteria for Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), or dementia.
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Subjective Cognitive Decline (SCD) Group:
- Taiwanese version of the Montreal Cognitive Assessment (MoCA) score > 23.
- Subjective Cognitive Decline Questionnaire (SCD-Q) score > 7 (out of a total score of 24).
- Answers "Yes" to both of the following questions: "Do you feel that you have memory problems compared to your previous normal state?" and "Have your family members or close friends noticed that you have memory problems compared to your previous state?"
- Normal performance on standardized neuropsychological tests (Color Trails Test and memory-related tests), defined as scoring higher than 1.5 standard deviations below the age- and education-adjusted normative mean.
- Does not meet the diagnostic criteria for Mild Cognitive Impairment (MCI) or dementia.
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Mild Cognitive Impairment (MCI) Group:
- Taiwanese version of the Montreal Cognitive Assessment (MoCA) score > 21.
- Diagnosed with Mild Cognitive Impairment (MCI) by a neurologist or psychiatrist.
- Does not meet the diagnostic criteria for dementia.
Exclusion Criteria (Applicable to All Participants):
- Meets the clinical diagnostic criteria for dementia.
- Geriatric Depression Scale Short-Form (GDS-S) score >= 8, or cognitive changes caused by other psychiatric disorders, neurological diseases, or substance abuse with unstable medical conditions and interfering symptoms.
- Severe visual or hearing impairments that prevent the completion of cognitive function assessments.
- Physical illnesses or conditions that prevent participation in the cognitive and physical training interventions.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Daily Life VR Training (IADL-VR)
Participants practice multi-step, realistic daily scenarios on a touchscreen computer, including shopping and cooking for a holiday meal, hospital registration and medication management, and travel planning. |
Delivered on a 16-inch touchscreen computer incorporating touch, handwriting recognition, and voice interaction. The software features three core daily living themes with 3 to 4 sequential sub-tasks each, graded across 5 to 8 difficulty levels:
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Comparador activo: Non-Conditional Game VR Training (Game-VR)
Participants play short, decontextualized digital brain-training mini-games targeting attention, memory, math, and language. |
Uses commercial digital cognitive games consisting of 22 short mini-games (under 2 minutes each) across five domains: attention, memory, mathematics, general cognition, and language, without real-life situational integration. |
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Comparador activo: Traditional Cognitive Training (Cog-Entity)
Participants engage in therapist-guided tabletop board games targeting various cognitive skills. |
Uses structured commercial board games and tabletop activities facilitated by an occupational therapist, focusing on a specific cognitive domain each week (attention, working memory, visuospatial skills, executive function, cognitive flexibility, and language). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Subjective Cognitive Decline Questionnaire (SCD-Q)
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Assessed via a semi-structured interview based on the 24 items of the Subjective Cognitive Decline Questionnaire (SCD-Q). Participants identify up to 5 of their most concerning daily life cognitive difficulties and rate each item on two dimensions: (1) Frequency of occurrence, rated from 1 to 10 (where 10 indicates very frequent occurrence), and (2) Perceived distress/bother level, rated from 1 to 10 (where higher scores indicate lower distress, with 10 representing no distress at all). |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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The Brief University of California San Diego Performance-Based Skills Assessment-Traditional Chinese Version (UPSA-B)
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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An objective, performance-based measure that evaluates instrumental activities of daily living (IADL) in simulated real-world scenarios across two domains: financial skills and communication skills (telephone use). Total scores range from 0 to 100, with higher scores indicating better everyday functional performance. |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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IADL Context-Based Cognitive Flexibility Assessment (ICFA)
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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A performance-based assessment evaluating cognitive flexibility within daily life contexts across 5 IADL-related scenarios (e.g., public transportation use, financial management, and daily life problem-solving). Each scenario consists of two parts assessing (1) spontaneous cognitive flexibility and (2) reactive cognitive flexibility (including intra-dimensional and extra-dimensional shifting). Higher scores indicate better real-life cognitive flexibility. |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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the Taiwanese Version of the Montreal Cognitive Assessment (MoCA-T)
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Assesses global cognitive function across 8 cognitive domains: visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. Total scores range from 0 to 30, with higher scores indicating better global cognitive function. |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Color Trails Test (CTT)
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Evaluates sustained attention, alternating attention, and executive function. Consists of two parts: CTT-1 requires connecting numbered circles from 1 to 25 in sequence as quickly as possible; CTT-2 requires connecting numbered circles from 1 to 25 while alternating between pink and yellow colors. Measured by completion time (in seconds), where shorter completion times indicate better attention and executive functioning. |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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the Wechsler Memory Scale-Third Edition (WMS-III) Family Pictures Subtest
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Evaluates immediate and delayed visual memory. Participants view 4 pictures of family scenes and are asked to recall the characters, their spatial locations, and their activities immediately and after a 25-to-35-minute delay. Scores for both immediate recall and delayed recall range from 0 to 64, with higher scores indicating better visual memory. |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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the Wechsler Memory Scale-Third Edition (WMS-III) Spatial Span Subtest
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Assesses visuospatial working memory. Participants tap blocks on a board in the same order (Spatial Span Forward) or reverse order (Spatial Span Backward) as demonstrated by the examiner. Scores for the forward and backward subscales each range from 0 to 16 (total score range: 0 to 32), with higher scores indicating better visuospatial working memory. |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Functional Magnetic Resonance Imaging (fMRI)
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Evaluates changes in resting-state functional connectivity using a 3.0-Tesla MRI scanner (Magnetom Prisma, Siemens). Includes T1-weighted structural MRI (MPRAGE sequence) and blood-oxygen-level-dependent (BOLD) resting-state functional EPI sequences to assess neural network changes before and after the cognitive intervention. |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Word Sequence Learning Test
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Assesses short-term and delayed verbal memory across learning and 10-minute delayed recall phases. Scoring includes position score (range: 0 to 60), accuracy score (range: 0 to 60), total learning score (range: 0 to 20), and 10-minute delayed recall score (range: 0 to 30). Higher scores in each component indicate better verbal learning and memory performance. |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Tower of Hanoi (TOH) Completion Time
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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A performance-based task evaluating executive planning and problem-solving skills. Participants move perforated disks of varying sizes across three pegs from an initial state to a goal state while adhering to specific rules. This outcome assesses task execution efficiency, measured as the total completion time in seconds across all test trials. Shorter completion times indicate better planning and problem-solving ability. |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Tower of Hanoi (TOH) Total Moves
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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A performance-based task evaluating executive planning and problem-solving skills. Participants move perforated disks of varying sizes across three pegs from an initial state to a goal state while adhering to specific rules. This outcome assesses movement efficiency, measured as the total number of moves made to complete the task. Fewer moves indicate more efficient planning and problem-solving ability. |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Tower of Hanoi (TOH) Rule Violations
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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A performance-based task evaluating executive planning and problem-solving skills. Participants move perforated disks of varying sizes across three pegs from an initial state to a goal state while adhering to specific rules (e.g., only one disk may be moved at a time, and a larger disk may never be placed on top of a smaller disk). This outcome assesses rule-following and inhibitory control during problem-solving, measured as the total number of rule violations committed across the test trials. Fewer rule violations indicate better executive control and planning ability. |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Geriatric Depression Scale Short-Form (GDS-S)
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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A 15-item self-report questionnaire assessing the severity of depressive symptoms in older adults. Total scores range from 0 to 15, with higher scores indicating more severe depressive symptoms (a score of 8 or higher suggests clinically significant depressive symptoms). |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Beck Anxiety Inventory (BAI)
Periodo de tiempo: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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A 21-item self-report inventory measuring the severity of emotional and somatic symptoms of anxiety. Each item is rated from 0 to 3, yielding a total score ranging from 0 to 63. Higher scores indicate more severe anxiety (8-15: mild to moderate anxiety; 16-25: moderate to severe anxiety; 26-63: severe anxiety). |
Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
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Colaboradores e Investigadores
Patrocinador
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Finalización primaria (Estimado)
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Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 202401189RINA
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data (IPD) will not be shared publicly due to participant privacy protections, ethical restrictions approved by the Institutional Review Board (IRB), and Taiwanese personal data protection regulations. Aggregate data and statistical results will be published in peer-reviewed scientific journals.
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.
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