Clinical trial NCT05837273: The Feasibility Usability and Effectiveness of Fully Immersive Horticultural-based Virtual Reality Cognitive Training for Community-dwelling Elderly
Official title: The Feasibility Usability and Effectiveness of Fully Immersive Horticultural-based Virtual Reality Cognitive Training for Community-dwelling Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fully Immersive Virtual Reality
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 75
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Occupational therapists

  1. Have clinical experience for more than one year
* Healthy aged Individuals:

  1. An initial MoCA scores ≧ 20
  2. age between 60 to 85
  3. ability to follow instructions and perform tasks
  4. willing to provide written informed consent

Exclusion Criteria:

* Occupational therapists

  1. History of severe dizziness or epilepsy
  2. Unstable physical conditions accompanied by neurological or other orthopedic diseases may affect immersive VR experience
  3. Recent diagnosis of psychiatric disorders
* Healthy aged individuals:

  1. An initial MoCA scores lower than 20
  2. 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

\[Effect study\]

Inclusion Criteria:

1. An initial MoCA scores ≧ 20
2. age between 60 to 85
3. ability to follow instructions and perform tasks
4. willing to provide written informed consent

Exclusion Criteria:

1. An initial MoCA scores lower than 20
2. 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

Primary outcomes:
measure: Change scores of Montreal Cognitive Assessment
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of Wechsler Memory Scale
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of Color trials test
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of Stroop test
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
Secondary outcomes:
measure: Change scores of Wechsler Adult Intelligence Scale; WAIS
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of the short (12-item) form of the Everyday Cognition Scale (ECog-12)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of the World Health Organization Quality of Life-Old(WHOQOL-OLD
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of WHOQOL-bref Taiwan Version
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of Community Integration Questionnaire, CIQ
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of Geriatric Depression Scale (GDS)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of The Chinese Aging Well Profile (CAWP)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of Timed up and go (TUG)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of 30 second chair stand test,CST
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of short physical performance battery,SPPB
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of International Physical Activity Questionnaires (IPAQ)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of The Clinical Frailty Scale (CFS)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
measure: Change scores of Reported Edmonton Frail Scale (REFS)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memotial Hospital
Study officials:
References: