- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hui-Fen Mao
- Numéro de téléphone: 886-3366-8178
- E-mail: huifen02@gmail.com
Lieux d'étude
-
-
-
Taipei, Taïwan
- Recrutement
- School of Occupational Therapy, College of Medicine, National Taiwan University
-
Contact:
- Hui-Fen Mao
- Numéro de téléphone: 886-3366-8178
- E-mail: huifen02@gmail.com
-
Chercheur principal:
- Hsiao-Wen Chen
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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:
-
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.
-
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.
-
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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:
|
|
Comparateur actif: 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. |
|
Comparateur actif: 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). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Subjective Cognitive Decline Questionnaire (SCD-Q)
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
|
The Brief University of California San Diego Performance-Based Skills Assessment-Traditional Chinese Version (UPSA-B)
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
|
IADL Context-Based Cognitive Flexibility Assessment (ICFA)
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
the Taiwanese Version of the Montreal Cognitive Assessment (MoCA-T)
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
|
Color Trails Test (CTT)
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
|
the Wechsler Memory Scale-Third Edition (WMS-III) Family Pictures Subtest
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
|
the Wechsler Memory Scale-Third Edition (WMS-III) Spatial Span Subtest
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
|
Functional Magnetic Resonance Imaging (fMRI)
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
|
Word Sequence Learning Test
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
|
Tower of Hanoi (TOH) Completion Time
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
|
Tower of Hanoi (TOH) Total Moves
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
|
Tower of Hanoi (TOH) Rule Violations
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
|
Geriatric Depression Scale Short-Form (GDS-S)
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
|
Beck Anxiety Inventory (BAI)
Délai: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)
|
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)
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
- 202401189RINA
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .