VR and Scrip Training of PWA, Randomized Controlled Trial

NCT06722092 | Not Yet Recruiting

• 1 other identifier: HSEARS20230228003-01
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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. 1.Can script training promote verbal functional communication of Cantonese-speaking PWA?
2. 2.Can script training enhance nonverbal cognitive functions of Cantonese-speaking PWA?
3. 3.Can VR magnify verbal and nonverbal treatment outcomes of script training of PWA?

Conditions

Aphasia, Acquired; Chronic Stroke

Keywords

functional communication; randomized controlled trial; script training; immersive reality; aphasia intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

  From baseline up to 8-week post training

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

  From baseline up to 8-week post training

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

  From baseline up to 8-week post training

Study Arms (3)

VR-based script training

EXPERIMENTAL

Behavioral: VR-based script training

Control

NO INTERVENTION

Computerized script training without VR

ACTIVE COMPARATOR

Behavioral: Conventional script training

Interventions

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.

VR-based script training

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.

Computerized script training without VR

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Prof FONG NAI KUEN KENNETH: collaborator
• Dr LI SHI PUI: collaborator
• Dr NG HIU FUNG PETER: collaborator
• Johns Hopkins University: collaborator

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Winsy WS Wong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Winsy WS Wong, PhD

CONTACT

852-34003117; wszewong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 9, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 13, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be shared starting from three months after manuscript publication.
• Access Criteria: The IPD and study protocol will be shared in an open-access data repository without restrictions.