VR and Scrip Training of PWA, Randomized Controlled Trial (VRSTPWA)

Can Immersive Virtual Reality Magnify Treatment Outcomes of Script Training on Cantonese Speakers with Chronic Aphasia: a Randomized Controlled Trial

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Aphasia, Acquired; Chronic Stroke
• Intervention / Treatment: Behavioral: VR-based script training; Behavioral: Conventional script training

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Winsy WS Wong, PhD; Phone Number: 852-34003117; Email: wszewong@polyu.edu.hk

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: VR-based script training	Behavioral: 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.
Active Comparator: Computerized script training without VR	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage accuracy of treatment probe correctly produced	Participant's production accuracy of the trained scripts in read-aloud and no-cue conditions.	From baseline up to 8-week post training
Time to produce each of the scripts in the treatment probe	Participant's production time of the trained scripts in read-aloud and no-cue conditions.	From baseline up to 8-week post training
Number of sessions to reach performance criteria in session probe		From baseline up to 8-week post training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cantonese version of the Western Aphasia Battery (CAB) to measure aphasia severity		From baseline up to 8-week post training
Cantonese version of the Amsterdam-Nijmegen Everyday Language Test to measure verbal communication effectiveness in conversation via 20 culturally appropriate scenarios		From baseline up to 8-week post training
Cantonese version of the 20-item Communication Outcome after Stroke (Can-COAST) as a self-reported outcome on communication and quality of life	The questionnaire consists of 20 questions, and participants will be asked to evaluate their functional communication and quality of life based on a 5-point Likert scale. Higher scores reflect better functional communication performance and quality of life.	From baseline up to 8-week post training
Subtest 1 (map search) and 3 (elevator counting) of Test of Everyday Attention to assess attention	The sub-test 1 aims to tap sustained and selective visual attention via identifying the target symbol in a map while the sub-test 3 assesses auditory selective attention via counting the number of target tones in the presence of distractors with different tones.	From baseline up to 8-week post training
Digit span forward and backward task to assess verbal short-term and working memory	The longest span of participant correctly recalled in the digit span forward and backward task.	From baseline up to 8-week post training
Test of Nonverbal Intelligence-third edition (TONI-3) to assess executive function	A norm-referenced test that uses abstract figures to evaluate abstract reasoning and problem-solving.	From baseline up to 8-week post training
Wisconsin Card Sort Test (WCST) to assess executive function	WCST assesses cognitive flexibility and reasoning via matching cards with respect to color, quantity, and shape upon different rules and feedback given.	From baseline up to 8-week post training

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Johns Hopkins University; Prof FONG NAI KUEN KENNETH; Dr LI SHI PUI; Dr NG HIU FUNG PETER
• Investigators: Principal Investigator: Winsy WS Wong, PhD, Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; functional communication; script training; aphasia intervention; immersive reality
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: HSEARS20230228003-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD, together with the study protocol, will be shared in an open-access data repository (e.g., OSF).
• IPD Sharing Time Frame: Data will be shared starting from three months after manuscript publication.
• IPD Sharing Access Criteria: The IPD and study protocol will be shared in an open-access data repository without restrictions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; 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