AphasiaNCT05606393
Establishment of Virtual Reality System for Stroke Patients With Aphasia
A study testing virtual reality speech training and traditional speech therapy in people with Aphasia, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Aphasia
- What is being tested?
- virtual reality speech training and traditional speech therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Apr 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei
Po-Yi Tsai, MD, 886-2-2871-2121
About this study
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.
Read the 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
- Being tested
- virtual reality speech training, traditional speech therapy
- Keywords
- virtual reality, aphasia, language rehabilitation, stroke
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality speech trainingOther
virtual reality speech training that focuses on receptive and expressive aspects of language, through a newly developed interactive virtual reality software
traditional speech therapyOther
traditional speech therapy in current clinical use, that focuses on language comprehension, naming, fluency, repetition.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: traditional speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and at 3 months after total treatments complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start7 Apr 2022
- Primary completionApr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606393
- Sponsor's protocol ID
- 2021-01-012C
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Virtual Reality System for Stroke Patients With Aphasia
- ClinicalTrials.gov ID
- NCT05606393
- Acronym / sponsor ID
- 2021-01-012C
- Conditions
- Aphasia
- Keywords
- virtual reality, aphasia, language rehabilitation, stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional speech therapy and additional virtual reality training group | Experimental | Other: virtual reality speech training, Other: traditional speech therapyEach 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 | Active comparator | Other: traditional speech therapyEach participant received 1-hour traditional speech therapy(ST) only for each session. All participants received 3 sessions of treatment every week for 3 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality speech trainingvirtual reality speech training that focuses on receptive and expressive aspects of language, through a newly developed interactive virtual reality software | Other | traditional speech therapy and additional virtual reality training group |
| traditional speech therapytraditional speech therapy in current clinical use, that focuses on language comprehension, naming, fluency, repetition. | Other | traditional speech therapy and additional virtual reality training group, traditional speech therapy group |
Primary outcome
Changes Concise Chinese Aphasia Test (CCAT) scores at 1 day after treatment
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality speech training and traditional speech therapy in people with Aphasia, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Po-Yi Tsai, MD (886-2-2871-2121 ext. 7364, pytsai@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes Concise Chinese Aphasia Test (CCAT) scores at 1 day after treatment (time frame: Baseline and at 1 day after total treatments complete). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.