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

January 20, 2025 updated by: The Hong Kong Polytechnic University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Hong Kong version of the Montreal Cognitive Assessment for the Visually Impaired (HKMoCA-VI)
Time Frame: The assessment was administered three times 15 days before and after treatment.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Holden Communication Scale
Time Frame: It was administered once one week before and after the intervention.
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)
Time Frame: Three times 15 days before and after treatment
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
Time Frame: The assessment was administered three times 15 days before and after treatment.
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
Time Frame: The assessment was administered three times 15 days before and after treatment.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Hong Kong
Tung Wah College
The Hong Kong Society for the Blind

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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