VR and Scrip Training of PWA, Randomized Controlled Trial

NCT ID: NCT06722092

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2028-06-30

Brief Summary

The goal of this RCT is to investigate if computerized script training may promote functional communication and nonverbal cognitive functions of Cantonese-speaking PWA, and whether VR may further magnify the treatment outcomes.

The main research questions are:

1. Can script training promote verbal functional communication of Cantonese-speaking PWA?

2. Can script training enhance nonverbal cognitive functions of Cantonese-speaking PWA?

3. Can VR magnify verbal and nonverbal treatment outcomes of script training of PWA?

Conditions

Aphasia, Acquired; Chronic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR-based script training

Group Type: EXPERIMENTAL

VR-based script training

Intervention Type: BEHAVIORAL

The PWA will wear a head-mounted VR device (e.g., Metaverse Oculus Quest 2 or other commercially available devices) for 30 minutes, which intends to create an immersive environment for training. Scripts trained in the computerized script training program in a particular session will be practiced. Cinematic 360˚ photo-real scenarios of daily contexts such as a restaurant or a grocery store will be displayed in the device while a communication partner, e.g., a waiter in the restaurant or a shopkeeper of a grocery store will initiate the conversation by producing the corresponding part of the script. The PWA will be given time to respond. Upon the completion of PWA's respond, the next conversational turn will be initiated. The clinical assistant, who accompanies the PWA in the entire training session, will control the flow of the 360 ˚ videos.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Computerized script training without VR

Group Type: ACTIVE_COMPARATOR

Conventional script training

Intervention Type: BEHAVIORAL

The flow of training is identical to the VR condition, except that photos depicting the scenarios and prerecorded conversational turns will be presented to the PWA on a computer screen with the same procedures mentioned in the VR condition.

Interventions

VR-based script training

The PWA will wear a head-mounted VR device (e.g., Metaverse Oculus Quest 2 or other commercially available devices) for 30 minutes, which intends to create an immersive environment for training. Scripts trained in the computerized script training program in a particular session will be practiced. Cinematic 360˚ photo-real scenarios of daily contexts such as a restaurant or a grocery store will be displayed in the device while a communication partner, e.g., a waiter in the restaurant or a shopkeeper of a grocery store will initiate the conversation by producing the corresponding part of the script. The PWA will be given time to respond. Upon the completion of PWA's respond, the next conversational turn will be initiated. The clinical assistant, who accompanies the PWA in the entire training session, will control the flow of the 360 ˚ videos.

Intervention Type: BEHAVIORAL

Conventional script training

The flow of training is identical to the VR condition, except that photos depicting the scenarios and prerecorded conversational turns will be presented to the PWA on a computer screen with the same procedures mentioned in the VR condition.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. a stroke onset more than six months, with an Aphasia Quotient (AQ) below 96.4, as evaluated by the Cantonese version of Western Aphasia Battery (CAB; Yiu, 1992),

2. premorbid fluent Cantonese speakers,

3. aged between 30 and 80 years,

4. no reported progressive neurogenic disorders such as dementia or Parkinson's disease,

5. no motor speech disorders of moderate to severe level, and

6. normal or corrected-to-normal vision and hearing functions

Exclusion Criteria

1. concurrent participation in other aphasia treatment trials, and

2. incompatibility with immersive VR exposure such as complains of nausea, headache, or other severe discomforts during trial use of a head-mounted device during screening.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof FONG NAI KUEN KENNETH

UNKNOWN

Sponsor Role: collaborator

Dr LI SHI PUI

UNKNOWN

Sponsor Role: collaborator

Dr NG HIU FUNG PETER

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Winsy WS Wong, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Polytechnic University

Central Contacts

Winsy WS Wong, PhD

Role: CONTACT

wszewong@polyu.edu.hk

852-34003117

Other Identifiers

HSEARS20230228003-01

Identifier Type: -

Identifier Source: org_study_id