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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06361901
Enrollment
20
Registered
2024-04-12
Start date
2023-11-17
Completion date
2024-12-31
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Speech Therapy, Stroke

Brief 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

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.

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

Sponsors

Korea University Guro Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Aphasic quatientEvaluate 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

Secondary

MeasureTime frameDescription
Change of cerebral blood flowEvaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.Change of cerebral blood flow with near-infrared spectroscopy

Countries

South Korea

Contacts

Primary ContactSeung Nam Yang, MD, PhD
snamyang@korea.ac.kr82-2-2626-1500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026