Virtual Reality Training Intervention on Cognitive Function and Quality of Life

NCT05329272 | Completed

• 1 other identifier: IShouU-VR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aimed to investigate the effects of a Virtual Reality cognitive training intervention (VRCTI) on cognitive function changes measured with a cognitive test battery and improvement of quality of life in older adults with cognitive impairment in long-term care facilities. Weekly 1-hour sessions were implemented over 8 weeks targeting sustained and selective attention, memory, cognitive functions, and rule deduction. The passive control group received usual care.

Conditions

Virtual Reality; Cognitive Impairment; Quality of Life

Keywords

Virtual Reality; Cognitive Impairment; Quality of Life; Long-term care facilities

Outcome Measures

Primary Outcomes (4)

• Cognitive Assessment Screening Instrument (CASI)

  The CASI evaluates global cognitive function using 9 cognitive domains: long-term memory, short-term memory, attention, mental manipulation, orientation, abstraction and judgment, language abilities, visual construction, and list-generating fluency. Typical administration time is about 20 minutes. The total score ranges from 0 to 100. A greater score demonstrates better global cognitive function.

  Change is being assessed. Change in Cognitive Assessment Screening Instrument (CASI) from baseline to immediately after the intervention.

• Mini-Mental State Examination (MMSE)

  General cognitive functioning was assessed with the Chinese version of the MMSE, which is a cognitive screening tool used to evaluate cognitive decline, screen for cognitive impairment, to evaluate the severity of the impairment, and to monitor cognitive change over time. The higher score indicates the better cognitive function.

  Change is being assessed. Change in Mini-Mental State Examination (MMSE) from baseline to immediately after the intervention.

• Clock Drawing Test-Drawing Part, (CDT-D)

  The CDT-D has been widely used as a neuropsychological screening test in the detection of cognitive impairment in populations. The lower the patients' clock scores the more likely were patients to be classified as impaired in elderly outpatients.

  Change is being assessed. Change in Clock Drawing Test-Drawing Part, (CDT-D) from baseline to immediately after the intervention.

• World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)

  The WHOQOL-BREF contains 28 items classified into the same 4 domains related to quality of life (physical health, psychological, social relationships and environment). All items were rated on a 5-point scale with a higher score indicating a higher quality of life.

  Change is being assessed. Change in World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF) from baseline to immediately after the intervention.

Study Arms (2)

The VR group: the Virtual Reality Cognitive Training Intervention (VRCTI)

EXPERIMENTAL

The VRCTI was developed to improve cognitive function. The intervention was designed that simulated schema of underwater world fish swimming. Each 1-hour session was typically divided into three parts: easy, medium and difficult, each with 4 different tasks, so there are 12 tasks/session in total. In some tasks, the VRCTI also distinguished between the real lure (e.g. a red triangle fish with a half-moon pattern) as well as unrelated lure items (i.e., blue square fish with polka dot pattern and other irrelevant items). The use of hardware elements for this study included visual (head-mounted display \[HMD\] in delivering the VR intervention), audio, and motor equipment.

Other: Virtual Reality Cognitive Training Intervention (VRCTI)

The control group

NO INTERVENTION

The control group received usual care.

Interventions

Virtual Reality Cognitive Training Intervention (VRCTI) OTHER

The VRCTI was developed to improve cognitive function. The intervention was designed that simulated schema of underwater world fish swimming. Each 1-hour session was typically divided into three parts: easy, medium and difficult, each with 4 different tasks, so there are 12 tasks/session in total. In some tasks, the VRCTI also distinguished between the real lure (e.g. a red triangle fish with a half-moon pattern) as well as unrelated lure items (i.e., blue square fish with polka dot pattern and other irrelevant items). The use of hardware elements for this study included visual (head-mounted display \[HMD\] in delivering the VR intervention), audio, and motor equipment.

The VR group: the Virtual Reality Cognitive Training Intervention (VRCTI)

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged ≥ 65 years
• Admitted as residents at the study-site institutions (long-term care facilities)
• Mini Mental Status Examination (MMSE) ≥ 13
• Able to communicate sufficiently

You may not qualify if:

• Open facial wounds
• Problems with a finger, hand, or wrist and/or major visual or auditory impairment, making it difficult to deliver training scheme
• Major neurological or psychiatric conditions that may affect cognition (e.g., stroke, dizziness, schizophrenia)
• Unstable medical conditions
• Were unable to comply with the intervention

Sponsors & Collaborators

• I-Shou University: lead

Study Sites (1)

I-Shou University

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mei-Chi Hsu, Ph.D

  I-Shou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 14, 2022
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)