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Virtual Reality Training Intervention on Cognitive Function and Quality of Life

Primary Purpose

Virtual Reality, Cognitive Impairment, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Virtual Reality Cognitive Training Intervention (VRCTI)
Sponsored by
I-Shou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Virtual Reality focused on measuring Virtual Reality, Cognitive Impairment, Quality of Life, Long-term care facilities

Eligibility Criteria

65 Years - 99 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • I-Shou University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

The control group

Arm Description

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 control group received usual care.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 21, 2022
Last Updated
April 7, 2022
Sponsor
I-Shou University
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1. Study Identification

Unique Protocol Identification Number
NCT05329272
Brief Title
Virtual Reality Training Intervention on Cognitive Function and Quality of Life
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I-Shou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Cognitive Impairment, Quality of Life
Keywords
Virtual Reality, Cognitive Impairment, Quality of Life, Long-term care facilities

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The VR group: the Virtual Reality Cognitive Training Intervention (VRCTI)
Arm Type
Experimental
Arm Description
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.
Arm Title
The control group
Arm Type
No Intervention
Arm Description
The control group received usual care.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Cognitive Training Intervention (VRCTI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive Assessment Screening Instrument (CASI)
Description
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.
Time Frame
Change is being assessed. Change in Cognitive Assessment Screening Instrument (CASI) from baseline to immediately after the intervention.
Title
Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
Change is being assessed. Change in Mini-Mental State Examination (MMSE) from baseline to immediately after the intervention.
Title
Clock Drawing Test-Drawing Part, (CDT-D)
Description
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.
Time Frame
Change is being assessed. Change in Clock Drawing Test-Drawing Part, (CDT-D) from baseline to immediately after the intervention.
Title
World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Description
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.
Time Frame
Change is being assessed. Change in World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF) from baseline to immediately after the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Chi Hsu, Ph.D
Organizational Affiliation
I-Shou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
I-Shou University
City
Kaohsiung City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data presented in this study are available on request from the researcher. The data are not publicly available due to privacy and ethical restrictions.

Learn more about this trial

Virtual Reality Training Intervention on Cognitive Function and Quality of Life

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