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CompletedNCT06361901Updated Oct 1, 2026

Comparison of Therapeutic Effect Between Speech Rehabilitation Program and Speech Therapy in Stroke Patients With Aphasia

An interventional study of Zenicog;language rehabilitation program and Conventional language rehabilitation in Stroke, Aphasia and Speech Therapy, sponsored by Korea University Guro Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Korea University Guro Hospital · Not applicable, Interventional, and Treatment

Updated Oct 1, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Stroke
  • Aphasia
  • Speech Therapy
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 20 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Korea University Guro Hospital is the lead sponsor of 89 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients who have difficulty to consent to research and participate in speech rehabilitation programs due to cognitive decline
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Language therapy group with language rehabilitation program

    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.

    Device: Zenicog;language rehabilitation program · Procedure: Conventional language rehabilitation

  • Active comparator
    Conventional language therapy group

    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.

    Procedure: Conventional language rehabilitation

Interventions

  • DeviceZenicog;language rehabilitation program

    This program is an AI-based computerized cognitive and language training program.

  • ProcedureConventional language rehabilitation

    Conventional language rahabilitation therapy will apply for all participants with speech impairement

06

What researchers measure

Primary outcomes

  1. Aphasic quatient

    Aphasic quatient using K-Western Aphasia Battery for aphasia assessment tools

    Time frame: 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

    Time frame: Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.

07

Study locations

1 site
  • Department of Rehabilitation Medicine, Korea University Guro Hospital
    Seoul, 08308, South Korea
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2023 to primary completion in Sep 2024, 9 months.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 9 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 1, 2026: primary completion Dec 2024 → Sep 2024 and completion Dec 2024 → Sep 2024.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2023
First posted
Apr 12, 2024
StartActual
Nov 17, 2023
Primary completionActual
Sep 6, 2024was Dec 2024
CompletionActual
Sep 6, 2024was Dec 2024
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 1, 2026
Primary completion
Dec 2024→Sep 6, 2024 (actual)
Oct 1, 2026
Study completion
Dec 2024→Sep 6, 2024 (actual)
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Recruiting→Completed
    Primary completion Dec 2024→Sep 6, 2024 (now actual)
    Study completion Dec 2024→Sep 6, 2024 (now actual)
    + 4 other changes: verification date, contact details, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06361901
Lead sponsor
Korea University Guro Hospital
Responsible party
Yang, Seung Nam (Professor, Korea University Guro Hospital) — Principal investigator
First posted
Apr 12, 2024
Start date
Nov 17, 2023
Primary completion
Sep 6, 2024
Completion
Sep 6, 2024
Last update
Oct 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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