Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05667480
Other study ID # P0043271
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03780296 - Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke N/A
Not yet recruiting NCT06057584 - Effect of Somatosensory Motor Intergration Training on Post-stroke Upper Limb Function. N/A
Completed NCT03228264 - A Trial Investigating Telerehabilitation as an add-on to Face-to-face Speech and Language Therapy in Post-stroke Aphasia. N/A
Completed NCT03531567 - Game-Based Home Exercise Programs in Chronic Stroke: A Feasibility Study N/A
Completed NCT02364232 - Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation N/A
Completed NCT04121754 - Post-Stroke Walking Speed and Community Ambulation Conversion Study N/A
Completed NCT04574687 - Effects of Action Observation Therapy on Fine Motor Skills of Upper Limb Functions in Chronic Stroke Patients. N/A
Recruiting NCT04974840 - Thera-band Resisted Treadmill Training for Chronic Stroke Patients N/A
Recruiting NCT04534556 - Wireless Nerve Stimulation Device To Enhance Recovery After Stroke N/A
Completed NCT04553198 - Quantifying the Role of Sensory Systems Processing in Post-Stroke Walking Recovery N/A
Completed NCT04226417 - Effect of Home Based Transcranial Direct Current Stimulation (tDCS) With Exercise on Upper and Lower Limb Motor Functions in Chronic Stroke N/A
Recruiting NCT06049849 - Can Patients With Chronic Stroke Regain Living Independence by Daily Energizing With Biophoton Generators N/A
Active, not recruiting NCT02881736 - Proprioceptive Deficits and Anomalies in Movement-error Processing in Chronic Stroke Patients N/A
Completed NCT03208634 - Rehabilitation Multi Sensory Room for Robot Assisted Functional Movements in Upper-limb Rehabilitation in Chronic Stroke N/A
Completed NCT05183100 - Effects of Neurodynamics on Lower Extremity Spasticity - a Study in Chronic Stroke N/A
Completed NCT03326349 - Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke N/A
Recruiting NCT04721860 - Optimizing Training in Severe Post-Stroke Walking Impairment N/A
Recruiting NCT06051539 - Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation N/A
Not yet recruiting NCT06060470 - Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke N/A
Recruiting NCT05591196 - Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke N/A