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

Not Applicable

Recruiting

• Conditions: Stroke; Aphasia; Speech Therapy
• Interventions: Procedure: Conventional language rehabilitation; Device: Zenicog;language rehabilitation program

• Registration Number: NCT06361901
• Lead Sponsor: Korea University Guro Hospital

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.

Study Timeline

• Study Start: 2023-11-17
• Study First Submitted: 2023-11-27
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional language therapy group	Conventional language rehabilitation	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.
Language therapy group with language rehabilitation program	Zenicog;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.
Language therapy group with language rehabilitation program	Conventional language rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Aphasic quatient	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of