Clinical Trial Title A Multicenter, Single-Blind, Prospective, Randomized, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of the Digital Therapeutic Device 'Zenicom' for Improving Aphasia in Patients with Subacute Stroke
Clinical Trial Objectives To evaluate the efficacy of the digital therapeutic device Zenicom.
To evaluate the safety of the digital therapeutic device Zenicom.
Clinical Trial Period 6 months from the date of clinical trial plan approval by the Ministry of Food and Drug Safety (MFDS).
Target Condition Patients with aphasia resulting from stroke lesions.
Target Sample Size Total of 20 subjects (10 in the experimental group and 10 in the control group).
Investigational Medical Device Zenicom
Clinical Trial Methodology
1. Device Information
A) Experimental Device: Digital Speech Therapy Application
Group: Performs conventional speech therapy for 30 minutes daily + additional digital speech therapy program during the 2-week treatment period.
B) Control Device: Conventional Speech Therapy
Group: Performs only conventional speech therapy for 30 minutes daily during the 2-week treatment period.
2. Treatment Duration:
Total 2 weeks (10 working days; total usage of 600 minutes or more).
3. Visits:
Total of 3 visits including outpatient and therapy room visits.
Visit 1 (T-1): Screening
Visit 2 (T0): Baseline and Treatment initiation
Visit 3 (T1): Post-treatment assessment
Inclusion and Exclusion Criteria
1. Inclusion Criteria Patients who satisfy all of the following criteria:
Adults aged 19 years or older.
Patients confirmed by a specialist to have aphasia caused by a stroke lesion.
Patients with first-ever subacute stroke (within 3 months of onset) diagnosed via radiological examination (CT, MRI).
Patients diagnosed with aphasia based on the Speech Assessment (PK-WAB-R).
Patients whose native language is Korean.
Patients capable of voluntarily consenting to the study.
2. Exclusion Criteria Patients meeting any of the following criteria will be excluded:
Progressive or hemodynamically unstable stroke.
Patients with other neurological diseases suspected to affect language ability.
Co-morbid major psychiatric disorders requiring continuous medication (e.g., Major Depressive Disorder, Schizophrenia, Bipolar Disorder, Dementia).
Co-morbid major neurogenic diseases other than stroke.
Confirmed history of degenerative neuropathy.
Current or past substance or alcohol use disorder.
Visual impairment (Low vision severity: visual acuity of 0.1-0.3 or lower).
Intellectual disability.
Illiteracy (unable to read and consent).
Patients deemed inappropriate for participation for other reasons.
Refusal to participate in the study.
Suspension and Dropout Criteria
1. Suspension Criteria
If circumstances observed during the trial make it judged unreasonable to continue the study.
Occurrence of Serious Adverse Events (SAE).
2. Dropout Criteria
The subject requests to stop participation or withdraws consent during the trial.
The investigator determines that the subject cannot continue the trial due to adverse events (e.g., headache, eye fatigue, nausea, dizziness, etc.).
The subject arbitrarily takes medication expected to affect the comparative evaluation of the investigational device during the trial.
The dosage of medication that may affect the comparative evaluation of the investigational device is changed during the trial.
Discovery of major protocol violations, such as violation of inclusion/exclusion criteria.
The subject fails to attend scheduled visits and cannot be contacted.
The subject fails to perform the digital speech therapy program for a total of 600 minutes or more.
The investigator determines that the trial should be stopped for other reasons.
Endpoints (Outcome Measures)
1. Primary Efficacy Endpoint
Change in PK-WAB-R scores between T0 and T1 between groups.
2. Secondary Efficacy Endpoints
Change in K-BNT scores between T0 and T1 between groups.
Change in K-SAQOL-12 scores between T0 and T1 between groups.
Statistical Analysis Methods To evaluate the change in PK-WAB-R between T0 and T1 between groups, an independent two-sample test will be used. Depending on the distribution of the change, a parametric method (Student's t-test) or a non-parametric method (Mann-Whitney U test) will be selected and applied.
To evaluate the changes in K-BNT and K-SAQOL-12 between T0 and T1 between groups, an independent two-sample test will be used. Depending on the distribution of the change, a parametric method (Student's t-test) or a non-parametric method (Mann-Whitney U test) will be selected and applied.
