NCT06793384

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
Last Updated

January 27, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

January 20, 2025

Last Update Submit

January 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Holden Communication Scale

    It was administered once one week before and after the intervention.

  • Cantonese version of the Amsterdam-Nijmegan Everyday Language Test (CANELT)

    Three times 15 days before and after treatment

  • Procedural description of making a ham-and-egg sandwich

    The assessment was administered three times 15 days before and after treatment.

  • Synonym judgement

    The assessment was administered three times 15 days before and after treatment.

Study Arms (2)

Conventional CST group

ACTIVE COMPARATOR

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)

VR-CST

EXPERIMENTAL

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)

Interventions

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.

VR-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.

Conventional CST group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cantonese speakers;
  • 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,
  • a diagnosis of mild to moderate visual impairment determined by an optometrist,
  • no other disability including physical illness, learning disability and severe hearing impairment that may affect participation in group activity,
  • not currently on psychiatric medication/cognitive intervention, (6) no history of other neurological diseases, and
  • (7) did not receive any prior CST.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Society for the Blind

Hong Kong, 000000, Hong Kong

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 27, 2025

Study Start

September 1, 2019

Primary Completion

February 28, 2020

Study Completion

May 31, 2020

Last Updated

January 27, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Participants' performance (raw scores) on primary and secondary outcomes throughout the study period will be shared on an open access repository (e.g., OSF).

Shared Documents
ICF
Time Frame
From Feb 2025 to Jan 2034
Access Criteria
There is no restriction to access.

Locations