Clinical trial NCT05667480: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aphasia, Acquired
Chronic Stroke
Keywords: functional communication
randomized study
script training
immersive virtual reality
aphasia intervention
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 26
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 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.


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 correct in reading aloud the sentences included in the trained scripts
timeFrame: From baseline up to 1-week post training
measure: Time required in read aloud of trained scripts
timeFrame: From baseline up to 1-week post training
measure: Percentage correct in spontaneous production of the sentences included in the trained scripts
timeFrame: From baseline up to 1-week post training
measure: Time required for spantaneous production of trained scripts
timeFrame: From baseline up to 1-week post training
Secondary outcomes:
measure: CAB
timeFrame: From baseline up to 1-week post training
measure: CANELT
timeFrame: From baseline up to 1-week post training
measure: Percentage correct in producing untrained but related scripts
timeFrame: From baseline up to 1-week post training
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Polytechnic University
state: Hong Kong SAR
Study officials:
affiliation: Hong Kong Polytechnic University
name: Winsy WS Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: