The Feasibility Usability and Effectiveness of Fully Immersive Horticultural-based Virtual Reality Cognitive Training for Community-dwelling Elderly

NCT05837273 | Unknown

• 1 other identifier: 202300244B0
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The pilot study will be a novel investigation of the usability and feasibility of leisure activities-based fully immersive VR cognitive training systems for cognitive training. We will recruit healthy aged individuals and occupational therapists for usability plus feasibility evaluation and perform the comparison of the effect with the developed VR intervention on psychological, daily life function and quality of life outcomes in populations experiencing cognitive decline. The fully-immersive VR system applied with horticultural therapy will be conducted in cognitive training and it was equipped with a headset and a pair of controllers for motion estimation and monitoring in a virtual environment. The findings of the research will effectively lead to advancement of the fully immersive leisure-based virtual reality cognitive training for elderly with cognitive decline.

Conditions

Fully Immersive Virtual Reality

Outcome Measures

Primary Outcomes (4)

• Change scores of Montreal Cognitive Assessment

  The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.

  baseline, after the intervention eight weeks, and at 3-month follow-up

• Change scores of Wechsler Memory Scale

  Including Faces Recognition (total scale=48), Verbal Paired Associates (total scale = 32), Word Lists (total scale = 48), and Spatial Span (total scale=32) will be used to assess the immediate, delayed, and working memory tests. For each subtest, a higher number indicates better performance in memory function. The raw score of subtests will also be transferred to standardized Z scores and summed to represent an index of general memory function.

  baseline, after the intervention eight weeks, and at 3-month follow-up

• Change scores of Color trials test

  For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.

  baseline, after the intervention eight weeks, and at 3-month follow-up

• Change scores of Stroop test

  The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. The time to complete the task will be calculated for each condition

  baseline, after the intervention eight weeks, and at 3-month follow-up

Secondary Outcomes (14)

• Change scores of Wechsler Adult Intelligence Scale; WAIS

  baseline, after the intervention eight weeks, and at 3-month follow-up

• Change scores of the short (12-item) form of the Everyday Cognition Scale (ECog-12)

  baseline, after the intervention eight weeks, and at 3-month follow-up

• Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL

  baseline, after the intervention eight weeks, and at 3-month follow-up

• Change scores of the World Health Organization Quality of Life-Old(WHOQOL-OLD

  baseline, after the intervention eight weeks, and at 3-month follow-up

• Change scores of WHOQOL-bref Taiwan Version

  baseline, after the intervention eight weeks, and at 3-month follow-up

Study Arms (3)

Fully immersive leisure-based virtual reality

EXPERIMENTAL

Device: Fully-immersive VR

Conventional cognitive training

EXPERIMENTAL

Behavioral: Cognitive training

control group

NO INTERVENTION

Interventions

Fully-immersive VR DEVICE

For fully-immersive VR sets the highest level of immersion of VR technologies, presenting improvement in cognitive function in cognitive decline seniors. Fully immersive VR-based cognitive training also has a positive effect on psychological performance.

Fully immersive leisure-based virtual reality

Cognitive training BEHAVIORAL

For the cognitive training, the therapy is a non-pharmacological approach, used for a series of standardized tasks to maintain or even increase person's cognitive function. The therapy can effectively improve multiple cognitive performance, such as: attention, reaction time (processing speed), working memory, and visual-spatial ability.

Conventional cognitive training

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Occupational therapists
• \. Have clinical experience for more than one year
• Healthy aged Individuals:
• An initial MoCA scores ≧ 20
• age between 60 to 85
• ability to follow instructions and perform tasks
• willing to provide written informed consent

You may not qualify if:

• Occupational therapists
• History of severe dizziness or epilepsy
• Unstable physical conditions accompanied by neurological or other orthopedic diseases may affect immersive VR experience
• Recent diagnosis of psychiatric disorders
• Healthy aged individuals:
• An initial MoCA scores lower than 20
• History of psychiatric disorders, major perceptual (visual or auditory) impairments, migraine or epilepsy, motion-sickness sensitive, unable to provide informed written consent due to severe cognitive impairment
• \[Effect study\]
• An initial MoCA scores ≧ 20
• age between 60 to 85
• ability to follow instructions and perform tasks
• willing to provide written informed consent
• An initial MoCA scores lower than 20
• History of psychiatric disorders, major perceptual (visual or auditory) impairments, migraine or epilepsy, motion-sickness sensitive, unable to provide informed written consent due to severe cognitive impairment

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memotial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Ching-yi Wu, ScD

CONTACT

#886-3-2118800; cywu@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: May 1, 2023
• Study Start: May 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 1, 2023

Record last verified: 2023-03

Locations

TW (1)