- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06361901
Sammenligning af terapeutisk effekt mellem talerehabiliteringsprogram og taleterapi hos slagtilfældepatienter med afasi
Sammenligning af terapeutisk effekt og hjerneaktivitet i henhold til sprogrehabiliteringsprogram og sprogterapi hos patienter med talesvækkelse efter slagtilfælde. Prospektiv, randomiseret, enkeltblind, eksplorativ klinisk undersøgelse
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Seoul, Sydkorea, 08308
- Department of Rehabilitation Medicine, Korea University Guro Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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. |
This program is an AI-based computerized cognitive and language training program. Conventional language rahabilitation therapy will apply for all participants with speech impairement |
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Aktiv komparator: 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. |
Conventional language rahabilitation therapy will apply for all participants with speech impairement |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Aphasic quatient
Tidsramme: Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.
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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.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change of cerebral blood flow
Tidsramme: Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.
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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.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Karsygdomme
- Hjerte-kar-sygdomme
- Psykiske lidelser
- Neuroadfærdsmæssige manifestationer
- Neuroudviklingsforstyrrelser
- Sprogforstyrrelser
- Taleforstyrrelser
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Slag
- Afasi
- Kommunikationsforstyrrelser
Andre undersøgelses-id-numre
- 2023GR0452
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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