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VR and Script Training of PWA

Primary Purpose

Aphasia, Acquired, Chronic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
VR-based script training
Conventional script training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia, Acquired focused on measuring functional communication, randomized study, script training, immersive virtual reality, aphasia intervention

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VR-based script training

Conventional script training

Arm Description

Outcomes

Primary Outcome Measures

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.
Time required in read aloud of trained scripts
Total time to read aloud the trained scripts
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.
Time required for spantaneous production of trained scripts
No written cue will be provided while the PWA will produce the scripts upon questions.

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2022
Last Updated
December 19, 2022
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05667480
Brief Title
VR and Script Training of PWA
Official Title
Utilization of Immersive Virtual Reality in Computerized Script Training for People With Aphasia: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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: Is VR-based script training a feasible treatment to Cantonese-speaking PWA? 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: Accuracy and time for producing trained scripts. Accuracy and time for producing un-trained scripts Standardized aphasia test on severity of language impairment Standardized aphasia test on functional communication The participants will be randomly allocated to receive one of the treatment: Virtual reality-based computerized script training; or 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Acquired, Chronic Stroke
Keywords
functional communication, randomized study, script training, immersive virtual reality, aphasia intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Winsy WS Wong, PhD
Phone
852-34003117
Email
wszewong@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winsy WS Wong, PhD
Organizational Affiliation
Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Polytechnic University
City
Hong Kong
State/Province
Hong Kong SAR
ZIP/Postal Code
852
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winsy WS Wong, PhD
Phone
852-34403117
Email
wszewong@polyu.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The IPD, together with the study protocol, will be shared in an open-access data repository (e.g., Harvard Dataverse).
IPD Sharing Time Frame
Data will be shared starting from three months after manuscript publication.
IPD Sharing Access Criteria
The IPD and study protocol will be shared in an open-access data repository without restrictions.

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VR and Script Training of PWA

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