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NCT Number: NCT06722092

VR and Scrip Training of PWA, 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?

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Key information

Conditions

Aphasia, Acquired Aphasia Chronic Stroke Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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),
  • premorbid fluent Cantonese speakers,
  • aged between 30 and 80 years,
  • no reported progressive neurogenic disorders such as dementia or Parkinson's disease,
  • no motor speech disorders of moderate to severe level, and
  • normal or corrected-to-normal vision and hearing functions

Exclusion criteria

  • concurrent participation in other aphasia treatment trials, and
  • 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.

Treatment and study plan

VR-based script training

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.

Conventional script training

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.

Primary outcomes

  1. Percentage accuracy of treatment probe correctly produced

    Time frame: From baseline up to 8-week post training

    Participant's production accuracy of the trained scripts in read-aloud and no-cue conditions.

  2. Time to produce each of the scripts in the treatment probe

    Time frame: From baseline up to 8-week post training

    Participant's production time of the trained scripts in read-aloud and no-cue conditions.

  3. Number of sessions to reach performance criteria in session probe

    Time frame: From baseline up to 8-week post training

Secondary outcomes

  1. Cantonese version of the Western Aphasia Battery (CAB) to measure aphasia severity

    Time frame: From baseline up to 8-week post training

  2. Cantonese version of the Amsterdam-Nijmegen Everyday Language Test to measure verbal communication effectiveness in conversation via 20 culturally appropriate scenarios

    Time frame: From baseline up to 8-week post training

  3. Cantonese version of the 20-item Communication Outcome after Stroke (Can-COAST) as a self-reported outcome on communication and quality of life

    Time frame: From baseline up to 8-week post training

    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.

  4. Subtest 1 (map search) and 3 (elevator counting) of Test of Everyday Attention to assess attention

    Time frame: From baseline up to 8-week post training

    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.

  5. Digit span forward and backward task to assess verbal short-term and working memory

    Time frame: From baseline up to 8-week post training

    The longest span of participant correctly recalled in the digit span forward and backward task.

  6. Test of Nonverbal Intelligence-third edition (TONI-3) to assess executive function

    Time frame: From baseline up to 8-week post training

    A norm-referenced test that uses abstract figures to evaluate abstract reasoning and problem-solving.

  7. Wisconsin Card Sort Test (WCST) to assess executive function

    Time frame: From baseline up to 8-week post training

    WCST assesses cognitive flexibility and reasoning via matching cards with respect to color, quantity, and shape upon different rules and feedback given.

Study contacts

Contact information is provided by the study sponsor or research team.

Winsy WS Wong, PhD

CONTACT

[email protected]

852-34003117

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Dr LI SHI PUI
  • Dr NG HIU FUNG PETER
  • Johns Hopkins University
  • Prof FONG NAI KUEN KENNETH

Registry information

Official study title

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

Acronym: VRSTPWA

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 9, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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