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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06361901
• Other study ID #: 2023GR0452
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Korea University Guro Hospital
• Contact: Seung Nam Yang, MD, PhD
• Phone: 82-2-2626-1500
• Email: snamyang[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Communication Disorders
• Speech Therapy
• Stroke

Intervention

Device:
• Zenicog;language rehabilitation program
This program is an AI-based computerized cognitive and language training program.

Procedure:
• Conventional language rehabilitation
Conventional language rahabilitation therapy will apply for all participants with speech impairement

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aphasic quatient	Aphasic quatient using K-Western Aphasia Battery for aphasia assessment tools	Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.
Secondary	Change of cerebral blood flow	Change of cerebral blood flow with near-infrared spectroscopy	Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.