VR and Script Training of PWA

NCT05667480 | Active Not Recruiting

• 1 other identifier: P0043271
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is VR-based script training a feasible treatment to Cantonese-speaking PWA?
2. 2.Will VR-based script training, when compared to conventional script training, better enhance treatment outcomes in functional communication of PWA?
3. 3.Accuracy and time for producing trained scripts.
4. 4.Accuracy and time for producing un-trained scripts
5. 5.Standardized aphasia test on severity of language impairment
6. 6.Standardized aphasia test on functional communication
7. 7.Virtual reality-based computerized script training; or
8. 8.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.

Conditions

Aphasia, Acquired; Chronic Stroke

Keywords

functional communication; randomized study; script training; immersive virtual reality; aphasia intervention

Outcome Measures

Primary Outcomes (4)

• 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

• Time required in read aloud of trained scripts

  Total time to read aloud the trained scripts

  From baseline up to 1-week post training

• 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

• 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 Outcomes (3)

• CAB

  From baseline up to 1-week post training

• CANELT

  From baseline up to 1-week post training

• Percentage correct in producing untrained but related scripts

  From baseline up to 1-week post training

Study Arms (2)

VR-based script training

EXPERIMENTAL

Behavioral: VR-based script training

Conventional script training

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 pre-recorded conversational turns will be presented to the PWA on a computer screen with the same procedures mentioned in the VR condition.

Conventional script training

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

Study Sites (1)

Hong Kong Polytechnic University

Hong Kong, Hong Kong SAR, 852, Hong Kong

Location

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

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 11, 2022
• First Posted: December 28, 2022
• Study Start: April 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• 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.

Locations

HK (1)