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

Keywords

• ADL performance
• Cognitive function
• virtual reality

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,609 studies on the registry; 574 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Eligibility criteria

Study arms

• 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.

  Behavioral: Daily Life VR Training

• Active comparator
  Non-Conditional Game VR Training (Game-VR)

  Participants play short, decontextualized digital brain-training mini-games targeting attention, memory, math, and language.

  Behavioral: Non-Conditional Game VR Training

• Active comparator
  Traditional Cognitive Training (Cog-Entity)

  Participants engage in therapist-guided tabletop board games targeting various cognitive skills.

  Behavioral: Traditional Cognitive Training

Interventions

• BehavioralDaily Life VR Training

  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: 1. Holiday Reunion Dinner Preparation: Checking home inventory to create a shopping list, supermarket shopping while filtering out audio promotional distractions, price comparison and checkout calculation, and following cooking sequences. 2. Health Management: Operating a hospital registration kiosk under time and step constraints, remembering physician and pharmacist instructions during a clinic visit, and organizing a medication pillbox. 3. Travel Planning: Packing luggage spatially, navigating bus and train schedules/platforms, reacting to unexpected events (e.g., retrieving blown-away luggage), and problem-solving during travel emergencies (e.g., lost items or suspended train services).

• BehavioralNon-Conditional Game VR Training

  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.

• BehavioralTraditional Cognitive Training

  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).

Primary outcomes

1. Subjective Cognitive Decline Questionnaire (SCD-Q)

   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).

   Time frame: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)

2. The Brief University of California San Diego Performance-Based Skills Assessment-Traditional Chinese Version (UPSA-B)

   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.

   Time frame: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)

3. IADL Context-Based Cognitive Flexibility Assessment (ICFA)

   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.

   Time frame: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)

Secondary outcomes

1. the Taiwanese Version of the Montreal Cognitive Assessment (MoCA-T)

   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.

   Time frame: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)

2. Color Trails Test (CTT)

   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.

   Time frame: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)

3. the Wechsler Memory Scale-Third Edition (WMS-III) Family Pictures Subtest

   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.

   Time frame: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)

4. the Wechsler Memory Scale-Third Edition (WMS-III) Spatial Span Subtest

   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.

   Time frame: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)

5. Word Sequence Learning Test

   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.

   Time frame: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)

6. Tower of Hanoi (TOH)

   A performance-based task evaluating executive planning and problem-solving skills. Participants move perforated disks of varying sizes across three pegs from a start state to a goal state while following specific rules. Performance is evaluated by the number of moves, completion time (in seconds), and number of rule violations, where fewer moves, shorter completion times, and fewer rule violations indicate better planning and problem-solving ability.

   Time frame: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)

7. Functional Magnetic Resonance Imaging (fMRI)

   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.

   Time frame: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)

8. Geriatric Depression Scale Short-Form (GDS-S)

   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).

   Time frame: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)

9. Beck Anxiety Inventory (BAI)

   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).

   Time frame: Baseline (within 2 weeks prior to intervention) and post-intervention (within 2 weeks after the 12-week intervention)

Individual participant data

Plan to share: No — 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.