Clinical trial NCT06722092: VR and Scrip Training of PWA, Randomized Controlled Trial
Official title: Can Immersive Virtual Reality Magnify Treatment Outcomes of Script Training on Cantonese Speakers with Chronic Aphasia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aphasia, Acquired
Chronic Stroke
Keywords: functional communication
randomized controlled trial
script training
immersive reality
aphasia intervention
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Prof FONG NAI KUEN KENNETH
name: Dr LI SHI PUI
name: Dr NG HIU FUNG PETER
name: Johns Hopkins University
First posted: 2024-12-09
Enrollment: 105
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage accuracy of treatment probe correctly produced
timeFrame: From baseline up to 8-week post training
measure: Time to produce each of the scripts in the treatment probe
timeFrame: From baseline up to 8-week post training
measure: Number of sessions to reach performance criteria in session probe
timeFrame: From baseline up to 8-week post training
Secondary outcomes:
measure: Cantonese version of the Western Aphasia Battery (CAB) to measure aphasia severity
timeFrame: From baseline up to 8-week post training
measure: Cantonese version of the Amsterdam-Nijmegen Everyday Language Test to measure verbal communication effectiveness in conversation via 20 culturally appropriate scenarios
timeFrame: From baseline up to 8-week post training
measure: Cantonese version of the 20-item Communication Outcome after Stroke (Can-COAST) as a self-reported outcome on communication and quality of life
timeFrame: From baseline up to 8-week post training
measure: Subtest 1 (map search) and 3 (elevator counting) of Test of Everyday Attention to assess attention
timeFrame: From baseline up to 8-week post training
measure: Digit span forward and backward task to assess verbal short-term and working memory
timeFrame: From baseline up to 8-week post training
measure: Test of Nonverbal Intelligence-third edition (TONI-3) to assess executive function
timeFrame: From baseline up to 8-week post training
measure: Wisconsin Card Sort Test (WCST) to assess executive function
timeFrame: From baseline up to 8-week post training
Other outcomes:
Locations:
Study officials:
affiliation: Hong Kong Polytechnic University
name: Winsy WS Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: