VR and Script Training of PWA

Utilization of Immersive Virtual Reality in Computerized Script Training for People with Aphasia: a Feasibility Study

The goal of this intervention study is to investigate the effects of immersive virtual reality in rehabilitation of language and communication of individuals with post-stroke aphasia. The main research questions are:

1. Is VR-based script training a feasible treatment to Cantonese-speaking PWA?
2. Will VR-based script training, when compared to conventional script training, better enhance treatment outcomes in functional communication of PWA?

Participants will be assessed before, in the middle of, immediately after treatment and 8-week post treatment in terms of their performance on:

1. Accuracy and time for producing trained scripts.
2. Accuracy and time for producing un-trained scripts
3. Standardized aphasia test on severity of language impairment
4. Standardized aphasia test on functional communication

The participants will be randomly allocated to receive one of the treatment:

1. Virtual reality-based computerized script training; or
2. Computerized script training without virtual reality Researchers will compare the treatment outcomes of the two treatment conditions and see if treatment with virtual reality would better promote outcomes when compared to training without virtual reality.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong SAR
    • Hong Kong, Hong Kong SAR, Hong Kong, 852
      • Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Conventional script training	Behavioral: Conventional script training; The flow of training is identical to the VR condition, except that photos depicting the scenarios and pre-recorded 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 correct in reading aloud the sentences included in the trained scripts	Trained scripts will be shown in written form while the PWA will be asked to read aloud the scripts.	From baseline up to 1-week post training
Time required in read aloud of trained scripts	Total time to read aloud the trained scripts	From baseline up to 1-week post training
Percentage correct in spontaneous production of the sentences included in the trained scripts	No written cue will be provided while the PWA will produce the scripts upon questions.	From baseline up to 1-week post training
Time required for spantaneous production of trained scripts	No written cue will be provided while the PWA will produce the scripts upon questions.	From baseline up to 1-week post training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAB	Cantonese version of the Western Aphasia Battery	From baseline up to 1-week post training
CANELT	Cantonese version of the Amsterdam-Nijmegen Everyday Language Test (ANELT; Blomert et al., 1994)	From baseline up to 1-week post training
Percentage correct in producing untrained but related scripts	No written cue will be provided while the PWA will produce the untrained scripts that share similar contexts with the trained scripts.	From baseline up to 1-week post training

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Winsy WS Wong, PhD, Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: December 11, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 28, 2022

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 study; functional communication; script training; immersive virtual reality; aphasia intervention
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: P0043271

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., Harvard Dataverse).
• 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