StrokeNCT06361901
Comparison of Therapeutic Effect Between Speech Rehabilitation Program and Speech Therapy in Stroke Patients With Aphasia
A study testing Zenicog;language rehabilitation program and Conventional language rehabilitation in people with Stroke and Aphasia, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
Our study will provide precise and intensive speech rehabilitation treatment program to patients with speech disorders after stroke, and compare clinical evaluations with the conventional speech therapy patient group. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke, Aphasia, Speech Therapy
- What is being tested?
- Zenicog;language rehabilitation program and Conventional language rehabilitation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Nov 2023to 6 Sep 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 19 years old
- Those with speech disorders that occurred after a stroke was diagnosed
- Those who can follow the clinical study procedures
- Those who voluntarily signed the consent form
Who cannot join
- Patients who have difficulty to consent to research and participate in speech rehabilitation programs due to cognitive decline
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Rehabilitation Medicine, Korea University Guro Hospital
Seoul, 08308
About this study
Official title: Comparison of Therapeutic Effect and Brain Activity According to Language Rehabilitation Program and Language Therapy in Patients With Speech Impairment After Stroke. Prospective, Randomized, Single-blind, Exploratory Clinical Study
Our study will provide precise and intensive speech rehabilitation treatment program to patients with speech disorders after stroke, and compare clinical evaluations with the conventional speech therapy patient group.
Clinical evaluation tools will be performed before and after the treatment for all patients
- K-Western Aphasia Battery for aphasia assessment tools
- Cerebral blood flow changes with near-infrared spectroscopy
Read the detailed description
During the initial evaluation of this study, the patient's gender, age, and onset of stroke lesion occurrence are collected and a cognitive evaluation is performed. In addition, the K-Western Aphasia Battery for aphasia assessment tools(K-WAB) and Cerebral blood flow changes with near-infrared spectroscopy will be performed. All participants will be assigned to a test group or control group. In addition to the existing speech rehabilitation treatment, the test group will receive a speech rehabilitation program, and the control group will receive the same treatment as the existing speech rehabilitation treatment.
After treatment is completed, the K-WAB test and near-infrared spectroscopy will be performed again.
- Conditions
- Stroke, Aphasia, Speech Therapy
- Being tested
- Zenicog;language rehabilitation program, Conventional language rehabilitation
- Medical subject headings
- Stroke, Aphasia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenicog;language rehabilitation programDevice
This program is an AI-based computerized cognitive and language training program.
Conventional language rehabilitationProcedure or surgery
Conventional language rahabilitation therapy will apply for all participants with speech impairement
| Study group | Role | What they receive |
|---|---|---|
| Language therapy group with language rehabilitation program | Experimental | In addition to 5-session conventional language therapy, we provide a 5-session language rehabilitation program using an AI-based computerized cognitive and language training program. A cognitive evaluation is conducted before starting treatment, and K-Western Aphasia Battery and Functional Near infrared spectroscopy are performed before and after the treatment. Receives: Device: Zenicog;language rehabilitation program; Procedure: Conventional language rehabilitation |
| Conventional language therapy group | Active comparator | We provide a 10-session conventional language therapy. A cognitive evaluation is conducted before starting treatment, and K-Western Aphasia Battery and Functional Near infrared spectroscopy are performed before and after the treatment. Receives: Procedure: Conventional language rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aphasic quatient
Aphasic quatient using K-Western Aphasia Battery for aphasia assessment tools
Measured: Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.
Secondary outcomes (1)
Change of cerebral blood flow
Change of cerebral blood flow with near-infrared spectroscopy
Measured: Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start17 Nov 2023
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang, Seung Nam, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361901
- Sponsor's protocol ID
- 2023GR0452
- Status last verified
- Sep 2026
- First submitted
- 27 Nov 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Therapeutic Effect and Brain Activity According to Language Rehabilitation Program and Language Therapy in Patients With Speech Impairment After Stroke. Prospective, Randomized, Single-blind, Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06361901
- Acronym / sponsor ID
- 2023GR0452
- Conditions
- Stroke, Aphasia, Speech Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 12 Apr 2024 (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.
Our study will provide precise and intensive speech rehabilitation treatment program to patients with speech disorders after stroke, and compare clinical evaluations with the conventional speech therapy patient group.
Clinical evaluation tools will be performed before and after the treatment for all patients
- K-Western Aphasia Battery for aphasia assessment tools
- Cerebral blood flow changes with near-infrared spectroscopy
Detailed description
During the initial evaluation of this study, the patient's gender, age, and onset of stroke lesion occurrence are collected and a cognitive evaluation is performed. In addition, the K-Western Aphasia Battery for aphasia assessment tools(K-WAB) and Cerebral blood flow changes with near-infrared spectroscopy will be performed. All participants will be assigned to a test group or control group. In addition to the existing speech rehabilitation treatment, the test group will receive a speech rehabilitation program, and the control group will receive the same treatment as the existing speech rehabilitation treatment.
After treatment is completed, the K-WAB test and near-infrared spectroscopy will be performed again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Language therapy group with language rehabilitation program | Experimental | Device: Zenicog;language rehabilitation program, Procedure: Conventional language rehabilitationIn addition to 5-session conventional language therapy, we provide a 5-session language rehabilitation program using an AI-based computerized cognitive and language training program. A cognitive evaluation is conducted before starting treatment, and K-Western Aphasia Battery and Functional Near infrared spectroscopy are performed before and after the treatment. |
| Conventional language therapy group | Active comparator | Procedure: Conventional language rehabilitationWe provide a 10-session conventional language therapy. A cognitive evaluation is conducted before starting treatment, and K-Western Aphasia Battery and Functional Near infrared spectroscopy are performed before and after the treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over 19 years old
- Those with speech disorders that occurred after a stroke was diagnosed
- Those who can follow the clinical study procedures
- Those who voluntarily signed the consent form
Key exclusion criteria (1 listed)
- Patients who have difficulty to consent to research and participate in speech rehabilitation programs due to cognitive decline
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 |
|---|---|---|
| Zenicog;language rehabilitation programThis program is an AI-based computerized cognitive and language training program. | Device | Language therapy group with language rehabilitation program |
| Conventional language rehabilitationConventional language rahabilitation therapy will apply for all participants with speech impairement | Procedure or surgery | Conventional language therapy group, Language therapy group with language rehabilitation program |
Primary outcome
Aphasic quatient
Time frame: Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.
Aphasic quatient using K-Western Aphasia Battery for aphasia assessment tools
1 secondary outcome
Change of cerebral blood flow
Time frame: Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenicog;language rehabilitation program and Conventional language rehabilitation in people with Stroke and Aphasia, run by Korea University Guro Hospital at 1 site in South Korea.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 1 Oct 2026. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aphasic quatient (time frame: Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.). 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 1 Oct 2026.