VR and Script Training of PWA

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05667480
Collaborator
(none)
26
1
2
19
1.4

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: VR-based script training
  • Behavioral: Conventional script training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Utilization of Immersive Virtual Reality in Computerized Script Training for People With Aphasia: A Feasibility Study
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: VR-based script training

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.

Active Comparator: Conventional script training

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Percentage correct in reading aloud the sentences included in the trained scripts [From baseline up to 1-week post training]

    Trained scripts will be shown in written form while the PWA will be asked to read aloud the scripts.

  2. Time required in read aloud of trained scripts [From baseline up to 1-week post training]

    Total time to read aloud the trained scripts

  3. Percentage correct in spontaneous production of the sentences included in the trained scripts [From baseline up to 1-week post training]

    No written cue will be provided while the PWA will produce the scripts upon questions.

  4. Time required for spantaneous production of trained scripts [From baseline up to 1-week post training]

    No written cue will be provided while the PWA will produce the scripts upon questions.

Secondary Outcome Measures

  1. CAB [From baseline up to 1-week post training]

    Cantonese version of the Western Aphasia Battery

  2. CANELT [From baseline up to 1-week post training]

    Cantonese version of the Amsterdam-Nijmegen Everyday Language Test (ANELT; Blomert et al., 1994)

  3. Percentage correct in producing untrained but related scripts [From baseline up to 1-week post training]

    No written cue will be provided while the PWA will produce the untrained scripts that share similar contexts with the trained scripts.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hong Kong Polytechnic University Hong Kong Hong Kong SAR Hong Kong 852

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Winsy WS Wong, PhD, Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT05667480
Other Study ID Numbers:
  • P0043271
First Posted:
Dec 28, 2022
Last Update Posted:
Dec 28, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Hong Kong Polytechnic University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2022