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

NCT06361901 | Recruiting

• 1 other identifier: 2023GR0452
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Aphasia; Speech Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of cerebral blood flow

  Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.

Study Arms (2)

Language therapy group with language rehabilitation program

EXPERIMENTAL

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; Procedure: Conventional language rehabilitation

Conventional language therapy group

ACTIVE COMPARATOR

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

Interventions

Zenicog;language rehabilitation program DEVICE

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

Language therapy group with language rehabilitation program

Conventional language rehabilitation PROCEDURE

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

Conventional language therapy group; Language therapy group with language rehabilitation program

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Department of Rehabilitation Medicine, Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke; Aphasia; Communication Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Seung Nam Yang, MD, PhD

CONTACT

82-2-2626-1500; snamyang@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: April 12, 2024
• Study Start: November 17, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

KR (1)