VR and Scrip Training of PWA, Randomized Controlled Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorThe Hong Kong Polytechnic University
About this 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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
VR-based script training
BehavioralThe 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
BehavioralThe 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.
Treatment groups
105 Participants
are divided into 3 treatment groupsGroup A: VR-based script trainingExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Group C: Computerized script training without VRActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage accuracy of treatment probe correctly produced
Participant's production accuracy of the trained scripts in read-aloud and no-cue conditions.
Time frame
From baseline up to 8-week post training2
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.
Time frame
From baseline up to 8-week post training3
Number of sessions to reach performance criteria in session probe
Time frame
From baseline up to 8-week post trainingSecondary outcomes
1
Cantonese version of the Western Aphasia Battery (CAB) to measure aphasia severity
Time frame
From baseline up to 8-week post training2
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 training3
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.
Time frame
From baseline up to 8-week post training4
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.
Time frame
From baseline up to 8-week post trainingLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Hong Kong Polytechnic University
Lead sponsor
Prof FONG NAI KUEN KENNETH
Collaborator
Dr LI SHI PUI
Collaborator
Dr NG HIU FUNG PETER
Collaborator
Johns Hopkins University
Collaborator
Source ClinicalTrials.gov
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