VR and Scrip Training of PWA, Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Aphasia, Acquired; Chronic Stroke

• Registration Number: NCT06722092
• Lead Sponsor: The Hong Kong Polytechnic University

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. 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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2025-02
• Primary Completion: 2027-12
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 105

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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.
Subtest 1 (map search) and 3 (elevator counting) of Test of Everyday Attention to assess attention	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.
Digit span forward and backward task to assess verbal short-term and working memory	From baseline up to 8-week post training	The longest span of participant correctly recalled in the digit span forward and backward task.
Test of Nonverbal Intelligence-third edition (TONI-3) to assess executive function	From baseline up to 8-week post training	A norm-referenced test that uses abstract figures to evaluate abstract reasoning and problem-solving.
Wisconsin Card Sort Test (WCST) to assess executive function	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.