The Feasibility and the Efficacy of the Full-immersive Virtual Reality Cognitive Training in Patients With Mild or Moderate Dementia

NCT ID: NCT07033468

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2027-07-31

Brief Summary

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.

Conditions

Mild to Moderate Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VR training therapy

Guide the patient through a 5-minute warm-up, which mainly involves explaining, familiarizing with, or reviewing VR operations. After the warm-up, proceed with the first part of the VR gardening training for 10 minutes, followed by 5 minutes of eye and stretching exercises. Then, continue with the second part of the VR gardening training for another 10 minutes, followed by 5 minutes of eye massage and stretching exercises. This sequence is repeated for a total of four cycles.

Group Type: EXPERIMENTAL

VR-WLC

Intervention Type: DEVICE

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.

CTL-VR

Intervention Type: DEVICE

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.

Waitlist control session

During the waitlist period, patients will not receive any training but will receive regular phone calls to ensure equal attention.

Group Type: OTHER

VR-WLC

Intervention Type: DEVICE

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.

CTL-VR

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age over 55 years;

2. Diagnosed with mild or moderate dementia (primarily degenerative dementia) by a consulting physician or based on past medical records;

3. A score of at least 11 but no more than 23 on the Mini-Mental State Examination (MMSE);

4. Has at least one family member or a regularly contacted friend (with the person's mobile number and contact at least once a week);

5. Able to walk independently and complete the Timed Up & Go (TUG) test;

6. Able to follow instructions with or without the assistance of a guardian or therapist;

7. 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

1. 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.

2. Severe health conditions that may hinder safe participation, such as respiratory distress, severe cardiovascular disease, or brain tumors.

3. A psychiatric diagnosis of psychosis within the past six months.

4. Diagnosis of Korsakoff syndrome.

5. History of substance addiction.

6. Severe hearing impairment or color blindness.

7. History of severe vertigo or epilepsy.

8. Concurrent participation in other studies that may affect cognitive function

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Tucheng Hospital, New Taipei City, commissioned and operated by Chang Gung Medical Foundation.

New Taipei City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ching-yi Wu, ScD

Role: CONTACT

cywu@mail.cgu.edu.tw

#886-3-2118800 ext. 5761

Facility Contacts

Ching-Yi Wu, ScD

Role: primary

cywu@mail.cgu.edu.tw

+886-3-2118800 Ext. 5761

Other Identifiers

202400517B0

Identifier Type: -

Identifier Source: org_study_id