Establishment of Virtual Reality System for Stroke Patients With Aphasia

NCT ID: NCT05606393

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-07
• Study Completion Date: 2023-10-31

Brief 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.

Detailed 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.

Conditions

Aphasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

traditional speech therapy and additional virtual reality training group

Each participant received 1-hour traditional speech therapy(ST) and additional 30-minute VR training immediately after each session of traditional ST. All participants received 3 sessions of treatment every week for 3 weeks.

Group Type: EXPERIMENTAL

virtual reality speech training

Intervention Type: OTHER

virtual reality speech training that focuses on receptive and expressive aspects of language, through a newly developed interactive virtual reality software

traditional speech therapy

Intervention Type: OTHER

traditional speech therapy in current clinical use, that focuses on language comprehension, naming, fluency, repetition.

traditional speech therapy group

Each participant received 1-hour traditional speech therapy(ST) only for each session. All participants received 3 sessions of treatment every week for 3 weeks.

Group Type: ACTIVE_COMPARATOR

traditional speech therapy

Intervention Type: OTHER

traditional speech therapy in current clinical use, that focuses on language comprehension, naming, fluency, repetition.

Interventions

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

Intervention Type: OTHER

traditional speech therapy

traditional speech therapy in current clinical use, that focuses on language comprehension, naming, fluency, repetition.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Po-Yi Tsai, MD

Role: CONTACT

pytsai@vghtpe.gov.tw

886-2-2871-2121 ext. 7364

Facility Contacts

Po-Yi Tsai, MD

Role: primary

886-2-2871-2121

Other Identifiers

2021-01-012C

Identifier Type: -

Identifier Source: org_study_id