Recruiting NCT07033468
The Feasibility and the Efficacy of the Full-immersive Virtual Reality Cognitive Training in Patients With Mild or Moderate Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR-WLC, CTL-VR.
- Who it may be relevant to
- Registry conditions: Mild to Moderate Dementia. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This project will explore the feasibility and efficacy of the fully immersive virtual reality leisure cognitive training tool developed by Chang Gung University in patients with mild to moderate dementia. The feasibility study will assess the feasibility and emotion-related indicators of 10 patients before and after a single training session. The efficacy study is planned to adopt a crossover randomized controlled trial, recruiting 30 patients for 15 sessions, each lasting 65 minutes, conducted three times a week. The assessment will include tests on the primary variable of cognitive function and secondary variables such as activities of daily living, quality of life, emotion, clinical symptoms, etc.
Interventions
- Device VR-WLC
First, conduct the Virtual Reality (VR) training activity. After the evaluation is completed, proceed to the Waitlist Control (WLC) session, approximately 5 to 10 weeks later. - Device CTL-VR
First, conduct the Control (CTL) session for approximately 5 to 10 weeks. After the evaluation is completed, proceed to the Virtual Reality (VR) training activity.
Primary outcome measures
- Change scores of Montreal Cognitive Assessment [Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
- Change scores of Stroop test [Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
- Change scores of Color trials test [Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
- Change scores of Frontal Assessment Battery [Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
Secondary outcome measures (6)
- Change scores of Barthel Index [Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
- Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL [Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
- Change scores of The Chinese Dementia-Quality of Life instrument, DQoL [Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
- Change scores of The Cornell Scale for Depression in Dementia Chinese version [Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
- Change scores of Clinical Dementia Rating, CDR [Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
- Change scores of Behavioral and Psychological Symptoms of Dementia, BPSD [Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
Eligibility criteria
Inclusion criteria
- Age over 55 years;
- Diagnosed with mild or moderate dementia (primarily degenerative dementia) by a consulting physician or based on past medical records;
- A score of at least 11 but no more than 23 on the Mini-Mental State Examination (MMSE);
- Has at least one family member or a regularly contacted friend (with the person's mobile number and contact at least once a week);
- Able to walk independently and complete the Timed Up \& Go (TUG) test;
- Able to follow instructions with or without the assistance of a guardian or therapist;
- If the assessment indicates moderate dementia, further evaluation will be conducted to determine whether the participant has sufficient capacity to provide informed consent. If their capacity is found to be impaired, the study will be explained to their legal representative
Exclusion criteria
- Dementia with Lewy Bodies and other dementia types resulting from specific causes, such as Huntington's Disease, substance addiction, central nervous system infections, nutritional deficiencies, and metabolic disorders.
- Severe health conditions that may hinder safe participation, such as respiratory distress, severe cardiovascular disease, or brain tumors.
- A psychiatric diagnosis of psychosis within the past six months.
- Diagnosis of Korsakoff syndrome.
- History of substance addiction.
- Severe hearing impairment or color blindness.
- History of severe vertigo or epilepsy.
- Concurrent participation in other studies that may affect cognitive function
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Tucheng Hospital, New Taipei City, commissioned and operated by Chang Gung Medical Foundat — New Taipei City
Identifiers
NCT: NCT07033468 · 202400517B0