Virtual Reality Training Intervention on Cognitive Function and Quality of Life

Quality of Life Clinical Trial

Official title:

Effects of Incorporating Virtual Reality Training Intervention Into Health Care on Cognitive Function and Quality of Life in Older Adults With Cognitive Impairment: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05329272
• Other study ID #: IShouU-VR
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: April 2022
• Source: I-Shou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Objectives: 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. Method: Weekly 1-hour sessions were implemented over 8 weeks targeting sustained and selective attention, memory, cognitive functions, and rule deduction. The VRCTI comprised 12 different tasks distributed in 8 sessions with different difficulty levels. The passive control group received usual care. Older adults were randomly assigned to either VR or control groups. An experimental pre-post design was used. Accuracy, error, and repetition rates were measured throughout each session. Intervention effects were analyzed using a generalized estimating equation model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Quality of Life
• Virtual Reality

Intervention

Other:
• Virtual Reality Cognitive Training Intervention (VRCTI)
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.

Locations

Country	Name	City	State
Taiwan	I-Shou University	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
I-Shou University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.