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

NCT ID: NCT06361901

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Stroke Aphasia Speech Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Zenicog;language rehabilitation program

Intervention Type DEVICE

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

Conventional language rehabilitation

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Conventional language rehabilitation

Intervention Type PROCEDURE

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

Interventions

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Zenicog;language rehabilitation program

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

Intervention Type DEVICE

Conventional language rehabilitation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yang, Seung Nam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Rehabilitation Medicine, Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seung Nam Yang, MD, PhD

Role: CONTACT

82-2-2626-1500

Facility Contacts

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Seung Nam Yang, MD, PhD

Role: primary

82-2-2626-1500

Other Identifiers

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2023GR0452

Identifier Type: -

Identifier Source: org_study_id

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