Establishment of Virtual Reality System for Stroke Patients With Aphasia

Aphasia Clinical Trial

Official title:

Establishment of Virtual Reality System for Stroke Patients With Aphasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606393
• Other study ID #: 2021-01-012C
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: October 2023

Study information

• Verified date: November 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Po-Yi Tsai, MD
• Phone: 886-2-2871-2121
• Email: pytsai[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aphasia can significantly influence a person's social relationship and quality of life. To achieve positive language outcomes, an intensive and high-repetition speech therapy is essential. However, due to the limited number of speech therapists, the intensity and frequency of training are often insufficient. Therefore, it is critical to develop other rehabilitation approaches to enhance the benefits of aphasia intervention. Virtual reality (VR) is an immersive and interactive computer simulation technology that can promote the ecological validity of speech therapy. In this study, we develop an innovative VR software for speech training to explore the effects of VR on various aspects of language outcomes.

Description:

We randomly assigned study participants into 2 groups: the traditional speech therapy (ST) group and the traditional ST with additional VR training (ST+VR) group. In the ST group, each participant received 1-hour traditional ST for each session. In the ST+VR group, an additional 30-minute VR training was administered immediately after each session of traditional ST. All participants received 3 sessions of treatment every week for 3 weeks. For outcome measurement, we administered Concise Chinese Aphasia Test (CCAT) at 3 different time points: before treatment, 1 day and 3 months after the completion of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of stroke with aphasia, including fluent and non-fluent types

• Age between 20~80-year-old

• Able to understand virtual reality training

• Able to cooperate with instructions and follow the rules

• Able to use the virtual reality controller and device

• Able to sign the subject's informed consent

Exclusion Criteria:

• Diagnosis of brain pathology other than stoke, such as brain tumor, Parkinson's disease, dementia

• Unable to cooperate with the instructions

• Unable to learn how to use the virtual reality controller and device

• Any medical diseases or unstable vital signs that may cause safety concern

• Severe hearing or vision impairments

• Have ever received any form of speech therapy or virtual reality training

Related Conditions & MeSH terms

• Aphasia

Intervention

Other:
• virtual reality speech training
virtual reality speech training that focuses on receptive and expressive aspects of language, through a newly developed interactive virtual reality software
• traditional speech therapy
traditional speech therapy in current clinical use, that focuses on language comprehension, naming, fluency, repetition.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes Concise Chinese Aphasia Test (CCAT) scores at 1 day after treatment	CCAT total scores and scores of subtests, including conversation, description, matching, listening comprehension, expression, reading recognition, sentence repetition, imitation, spontaneous writing	Baseline and at 1 day after total treatments complete
Primary	Changes of Concise Chinese Aphasia Test (CCAT) scores at 3 months after treatment	CCAT total scores and scores of subtests, including conversation, description, matching, listening comprehension, expression, reading recognition, sentence repetition, imitation, spontaneous writing	Baseline and at 3 months after total treatments complete