Establishment of Virtual Reality System for Stroke Patients With Aphasia

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.

Study Overview

• Status: Recruiting
• Conditions: Aphasia
• Intervention / Treatment: Other: virtual reality speech training; Other: traditional speech therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Po-Yi Tsai, MD; Phone Number: 7364 886-2-2871-2121; Email: pytsai@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei city, Taiwan
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Po-Yi Tsai, MD; Phone Number: 886-2-2871-2121

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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; Other: traditional speech therapy; traditional speech therapy in current clinical use, that focuses on language comprehension, naming, fluency, repetition.
Active Comparator: 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.	Other: traditional speech therapy; traditional speech therapy in current clinical use, that focuses on language comprehension, naming, fluency, repetition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: stroke; virtual reality; aphasia; language rehabilitation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: 2021-01-012C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No