VR and Script Training of PWA

Chronic Stroke Clinical Trial

Official title:

Utilization of Immersive Virtual Reality in Computerized Script Training for People With Aphasia: A Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05667480
• Other study ID #: P0043271
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: August 2024

Study information

• Verified date: November 2022
• Source: The Hong Kong Polytechnic University
• Contact: Winsy WS Wong, PhD
• Phone: 852-34003117
• Email: wszewong[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this intervention study is to investigate the effects of immersive virtual reality in rehabilitation of language and communication of individuals with post-stroke aphasia. The main research questions are: 1. Is VR-based script training a feasible treatment to Cantonese-speaking PWA? 2. Will VR-based script training, when compared to conventional script training, better enhance treatment outcomes in functional communication of PWA? Participants will be assessed before, in the middle of, immediately after treatment and 8-week post treatment in terms of their performance on: 1. Accuracy and time for producing trained scripts. 2. Accuracy and time for producing un-trained scripts 3. Standardized aphasia test on severity of language impairment 4. Standardized aphasia test on functional communication The participants will be randomly allocated to receive one of the treatment: 1. Virtual reality-based computerized script training; or 2. Computerized script training without virtual reality Researchers will compare the treatment outcomes of the two treatment conditions and see if treatment with virtual reality would better promote outcomes when compared to training without virtual reality.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Acquired
• Chronic Stroke

Intervention

Behavioral:
• VR-based script training
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
The flow of training is identical to the VR condition, except that photos depicting the scenarios and pre-recorded conversational turns will be presented to the PWA on a computer screen with the same procedures mentioned in the VR condition.

Locations

Country	Name	City	State
Hong Kong	Hong Kong Polytechnic University	Hong Kong	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage correct in reading aloud the sentences included in the trained scripts	Trained scripts will be shown in written form while the PWA will be asked to read aloud the scripts.	From baseline up to 1-week post training
Primary	Time required in read aloud of trained scripts	Total time to read aloud the trained scripts	From baseline up to 1-week post training
Primary	Percentage correct in spontaneous production of the sentences included in the trained scripts	No written cue will be provided while the PWA will produce the scripts upon questions.	From baseline up to 1-week post training
Primary	Time required for spantaneous production of trained scripts	No written cue will be provided while the PWA will produce the scripts upon questions.	From baseline up to 1-week post training
Secondary	CAB	Cantonese version of the Western Aphasia Battery	From baseline up to 1-week post training
Secondary	CANELT	Cantonese version of the Amsterdam-Nijmegen Everyday Language Test (ANELT; Blomert et al., 1994)	From baseline up to 1-week post training
Secondary	Percentage correct in producing untrained but related scripts	No written cue will be provided while the PWA will produce the untrained scripts that share similar contexts with the trained scripts.	From baseline up to 1-week post training