Establishment of Virtual Reality System for Stroke Patients With Aphasia

Not Applicable

Recruiting

• Conditions: Aphasia
• Interventions: Other: virtual reality speech training; Other: traditional speech therapy

• Registration Number: NCT05606393
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study Start: 2022-04-07
• Status Verified: 2022-11
• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-03
• Last Update Submitted: 2022-11-03
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04
• Primary Completion: 2023-04
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional speech therapy and additional virtual reality training group	virtual reality speech training	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.
traditional speech therapy group	traditional speech therapy	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.
traditional speech therapy and additional virtual reality training group	traditional speech therapy	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei city, Taiwan