Virtual Reality in Cognitive Stimulation Therapy for Visually Impaired Older Individuals with Dementia (VR-CST-PwDVI)

Applying Cognitive Stimulation Therapy (CST) and Virtual Reality-based CST on People with Concurrent Visual Impairment and Dementia: a Feasibility Pilot Study

Both visual impairment and dementia are prevalent in the elderly population. Cognitive stimulation therapy (CST) is an evidence-based intervention for people with mild-to-moderate dementia. Virtual reality (VR) has been used in cognitive rehabilitation. However, the efficacy of CST and the feasibility of incorporating VR into therapy targeting people with dementia and visual impairment (PwDVI) have rarely been explored. The current pilot study addressed two issues: 1) To study the efficacy of conventional CST on PwDVI in different cognitive domains and 2) To explore the feasibility and efficacy of VR-CST on PwDVI in various cognitive domains.

Study Overview

• Status: Completed
• Conditions: Dementia Patients
• Intervention / Treatment: Behavioral: Conventional Cognitive Stimulation Therapy (Conventional CST); Behavioral: Virtual reality based Cognitive Stimulation Therapy (VR-CST)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 000000
    • The Hong Kong Society for the Blind

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Cantonese speakers;
2. suspected or having a medical diagnosis of dementia, with the Montreal Cognitive Assessment 5-minute protocol (MoCA-5) score ranging from 2 to 17, which is equal to the Cantonese Mini Mental State Examination (MMSE) score ranging from 10 to 24 by using the conversion table from Wong et al,
3. a diagnosis of mild to moderate visual impairment determined by an optometrist,
4. no other disability including physical illness, learning disability and severe hearing impairment that may affect participation in group activity,
5. not currently on psychiatric medication/cognitive intervention, (6) no history of other neurological diseases, and

(7) did not receive any prior CST.

Exclusion Criteria:

1. currently on psychiatric medication/cognitive intervention, (6) no history of other neurological diseases,
2. currently on psychiatric medication/cognitive intervention, (6) no history of other neurological diseases,
3. prior exposure to CST

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional CST group; A total 14 sessions of conventional cognitive stimulation therapy (CST) with different themes were delivered twice a week to patients with dementia in groups of four to five. Therapy materials included real objects, pictures and videos presented via iPADs where users can enlarge the images manually or under facilitator's assistancd.	Behavioral: Conventional Cognitive Stimulation Therapy (Conventional CST); In the conventional CST group, 2-dimensional images/videos illustrating content identical to the VR-CST condition were displayed via tablet computers (see Table 2 for details) in which participants could manipulate the size of the image depicted or the pace of the videos with the help of the facilitator/therapy assistant.
Experimental: VR-CST; A total of 14 sessions of virtual reality cognitive stimulation therapy (VR-CST) with different themes were delivered twice a week to patients with dementia in groups of four to five. In the VR-CST condition, participants wore a head-mounted display (HMD; model: DPVR P1 Pro Headset) for the themed activities in every session except sessions 1 and 14. In these two sessions, group physical activities (such as passing a ball from one participant to another) were conducted, so no HMDs were used. In other sessions, panoramic images (e.g., wet market) and videos (e.g., the neighborhood surroundings) prepared by the project team were mainly used, supplemented by 2-dimensional images /videos in which preparing panoramic images/videos was deemed impossible.	Behavioral: Virtual reality based Cognitive Stimulation Therapy (VR-CST); In the VR-CST condition, participants wore a head-mounted display (HMD; model: DPVR P1 Pro Headset) for the themed activities in every session except sessions 1 and 14. In these two sessions, group physical activities (such as passing a ball from one participant to another) were conducted, so no HMDs were used. In other sessions, panoramic images (e.g., wet market) and videos (e.g., the neighborhood surroundings) prepared by the project team were mainly used, supplemented by 2-dimensional images /videos in which preparing panoramic images/videos was deemed impossible. Such a situation occurred in Session 5 (current affairs), in which news clips or captions from newspaper websites served as more appropriate content for discussion than self-created panoramic images/videos.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Hong Kong version of the Montreal Cognitive Assessment for the Visually Impaired (HKMoCA-VI)	It is a standarized assessment for global cognition for people with visual impairment.	The assessment was administered three times 15 days before and after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Holden Communication Scale	It is a questionnaire to evaluate the participants' communication and social behavior from a caregiver's perspective. Ratings were given by the formal carers of the old age homes for the visually imapired.	It was administered once one week before and after the intervention.
Cantonese version of the Amsterdam-Nijmegan Everyday Language Test (CANELT)	The test portrays 20 real-life situations encompassing different communicative functions, was conducted to evaluate functional communication quantitively. Scores were given based on the accuracy and completeness of the main concepts produced by the subjects.	Three times 15 days before and after treatment
Procedural description of making a ham-and-egg sandwich	A picture depicting a loaf of bread, ham and an egg were presented to the subject and s/he will be asked to describe the procedures of making an egg-and-ham sandwich as detailed as possible.	The assessment was administered three times 15 days before and after treatment.
Synonym judgement	A pair of words were presented auditorily and the participants were asked to judge if the pair of words were synonymous or not.	The assessment was administered three times 15 days before and after treatment.

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: The University of Hong Kong; Tung Wah College; The Hong Kong Society for the Blind

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: EA240610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participants' performance (raw scores) on primary and secondary outcomes throughout the study period will be shared on an open access repository (e.g., OSF).
• IPD Sharing Time Frame: From Feb 2025 to Jan 2034
• IPD Sharing Access Criteria: There is no restriction to access.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No