Utilization of Immersive Virtual Reality in Cognitive Stimulation Therapy (IVR-CST) for Elderly with Mild Cognitive Impairment: a Randomized Controlled Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Hong Kong Montreal Cognitive Assessment (HK-MoCA)
Study Overview
Brief Summary
The proposed study aims to investigate the potential of IVR-CST in improving cognition of people with MCI, and as well the association of eye movement during therapy and treatment outcomes of IVR-CST. Four research questions have been proposed and listed as follows:
- Is IVR-CST a feasible treatment for elderly with MCI?
- Is IVR-CST an efficacious treatment for improving cognition of elderly with MCI?
- Is IVR-CST more efficacious than conventional CST (i.e., without IVR) in improving the cognition of elderly with MCI?
- Is eye-tracking data collected during therapy associated with treatment outcomes of IVR CST?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •elderly aged 60 years or above,
- •a diagnosis of MCI made by a psychiatrist, or a score of 16-21 out of 30 in the Hong Kong Brief Cognitive Test (HKBC, 31), with upper and lower cutoff scores for MCI as suggested by the test. HKBC has been validated in Hong Kong with satisfactory sensitivity (0.88) and specificity ((0.81) in differentiating subjects with MCI and healthy individuals,
- •ability to speak and comprehend Cantonese,
- •normal or corrected-to-normal binocular vision and hearing,
- •absence of physical illness/disability to prevent them from IVR-CST participation, 6, compatible with IVR exposure in the 10-minute IVR trial without major signs of cybersickness, based on the symptoms given in the Simulator Sickness Questionnaire
Exclusion Criteria
- •concurrent participation in other clinical therapy trials,
- •incompatibility with IVR exposure such as complaints of nausea, headache, or other severe discomforts during trial use,
- •a diagnosis of dementia or other psychiatric/neurological diseases such as depression, stroke, brain trauma, Parkinson's disease
- •hearing/visual/upper limb impairments that hinder CST/IVR-CST participation,
- •prior CST treatment,
- •Use of medication for MCI/dementia, e.g., aducanumab
Arms & Interventions
IVR-CST Group
Intervention: IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy) (Behavioral)
Conventional CST Group
Intervention: Intervention Name: Conventional CST (Cognitive Stimulation Therapy) (Behavioral)
Outcomes
Primary Outcomes
Hong Kong Montreal Cognitive Assessment (HK-MoCA)
Time Frame: From 1-week pre-intervention to 13 weeks post-intervention
Hong Kong Montreal Cognitive Assessment (HK-MoCA) Measurement of global cognition in participants, covering various cognitive domains such as visuo-spatial skills, executive functions, attention, memory, language, and orientation. The total score ranges from 1-30, with higher score indicating better performance.
Digit Span Forward and Backward Tasks
Time Frame: From 1-week pre-intervention to 13 weeks post-intervention
Assessment of working memory capacity, predicting progression from MCI to dementia. The test will start from 1 digit with increasing number of digit to increase level of difficulty.
Verbal Fluency of Semantic Category
Time Frame: From 1-week pre-intervention to 13 weeks post-intervention
Evaluation of semantic integrity, cognitive flexibility, and executive function by measuring the number of items correctly produced in one minute across different semantic categories (animals, fruits, transportation).
Secondary Outcomes
- Chinese Version of the Modified Barthel Index(From 1-week pre-intervention to 13 weeks post-intervention)
- Hong Kong Lawton Instrumental Activities of Daily Living Scale(From 1-week pre-intervention to 13 weeks post-intervention)
- Feasibility Outcomes and Users' Experience(Throughout the intervention period (from weeks 1-7 of intervention))
- Semi-Structured Interview for IVR-CST Group(Immediately post-intervention)