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

April 11, 2024 updated by: Yang, Seung Nam, Korea University Guro Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 08308
        • Recruiting
        • Department of Rehabilitation Medicine, Korea University Guro Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Active Comparator: 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.
Procedure: Conventional language rehabilitation
Conventional language rahabilitation therapy will apply for all participants with speech impairement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aphasic quatient
Time Frame: 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
Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of cerebral blood flow
Time Frame: 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
Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023GR0452

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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