Establishment of Virtual Reality System for Stroke Patients With Aphasia

NCT05606393 | Unknown

• 1 other identifier: 2021-01-012C
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia

Keywords

virtual reality; aphasia; language rehabilitation; stroke

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

traditional speech therapy and additional virtual reality training group

EXPERIMENTAL

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.

Other: virtual reality speech training; Other: traditional speech therapy

traditional speech therapy group

ACTIVE COMPARATOR

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.

Other: traditional speech therapy

Interventions

virtual reality speech training 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 and additional virtual reality training group

traditional speech therapy OTHER

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

traditional speech therapy and additional virtual reality training group; traditional speech therapy group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Po-Yi Tsai, MD

CONTACT

886-2-2871-2121; pytsai@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 4, 2022
• Study Start: April 7, 2022
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)