Back to resultsEstablishment of Virtual Reality System for Stroke Patients With Aphasia
Primary Purpose
Aphasia
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
virtual reality speech training
traditional speech therapy
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring virtual reality, aphasia, language rehabilitation, stroke
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
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
traditional speech therapy and additional virtual reality training group
traditional speech therapy group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05606393
First Posted
November 1, 2022
Last Updated
November 3, 2022
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05606393
Brief Title
Establishment of Virtual Reality System for Stroke Patients With Aphasia
Official Title
Establishment of Virtual Reality System for Stroke Patients With Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
virtual reality, aphasia, language rehabilitation, stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
traditional speech therapy and additional virtual reality training group
Arm Type
Experimental
Arm Description
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.
Arm Title
traditional speech therapy group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
virtual reality speech training
Intervention Description
virtual reality speech training that focuses on receptive and expressive aspects of language, through a newly developed interactive virtual reality software
Intervention Type
Other
Intervention Name(s)
traditional speech therapy
Intervention Description
traditional speech therapy in current clinical use, that focuses on language comprehension, naming, fluency, repetition.
Primary Outcome Measure Information:
Title
Changes Concise Chinese Aphasia Test (CCAT) scores at 1 day after treatment
Description
CCAT total scores and scores of subtests, including conversation, description, matching, listening comprehension, expression, reading recognition, sentence repetition, imitation, spontaneous writing
Time Frame
Baseline and at 1 day after total treatments complete
Title
Changes of Concise Chinese Aphasia Test (CCAT) scores at 3 months after treatment
Description
CCAT total scores and scores of subtests, including conversation, description, matching, listening comprehension, expression, reading recognition, sentence repetition, imitation, spontaneous writing
Time Frame
Baseline and at 3 months after total treatments complete
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Yi Tsai, MD
Phone
886-2-2871-2121
Ext
7364
Email
pytsai@vghtpe.gov.tw
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei city
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Po-Yi Tsai, MD
Phone
886-2-2871-2121
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Establishment of Virtual Reality System for Stroke Patients With Aphasia
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