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A prospective, randomized, multi-centered clinical trial to investigate the effectiveness of the digital therapeutic device 'StroKcare' for speech rehabilitation for people with post-stroke dysarthria

A prospective, randomized, multi-centered clinical trial to investigate the effectiveness of the digital therapeutic device 'StroKcare' for speech rehabilitation for people with post-stroke dysarthria

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0008505
Enrollment
68
Registered
2023-06-08
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Patients with paralysis after stroke are recruited through screening tests and subjects who agree to participate in the study are placed in the experimental group or control group thr

Sponsors

Korea Technology & Information Promotion Agency for SMEs
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults over 19 years of age 2. Neurologically stable stroke patients as judged by doctors 3. Patients with paralysis due to stroke objectively from the doctor's judgment 4. A person with a cognitive function who has no problem using this digital treatment with a score of 21 or higher on the examination within one month of application of the digital treatment device 5. A person who has sufficient vision, hearing, language ability, motor function, and understanding to follow the test procedure 6. Those who have no difficulty using the mobile application of this study using general purpose equipment (smartphone) 7. A person who has heard and understood sufficient explanation of this clinical trial, has voluntarily decided to participate and has agreed in writing to comply with the precautions

Exclusion criteria

Exclusion criteria: 1. Patients with organic problems in oral and cervical structures, making it difficult to accurately measure 2. Patients diagnosed with dementia (including Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., HIV, syphilis, etc.), Crozfeldt-Jacob disease, Pixie disease, Huntington's disease, Parkinson's disease, etc.) 3. Those who have a CDR score of 1 or higher evaluated at the time of screening 4. A person who has administered dementia treatment within the past three months as of the time of screening 5. A person who is illiterate 6. A person with serious mental illnesses such as severe depression, schizophrenia, alcoholism, and drug dependence 7. A person who is unable to use a digital treatment due to severe speech impairment when judged by a doctor 8. Those who have difficulty using a smartphone 9. A person who determines that the tester is unfit to participate in a clinical trial due to other reasons 10. Those who refused to participate in this study

Design outcomes

Primary

MeasureTime frame
Speech Intelligibility

Secondary

MeasureTime frame
Maximum Phonation Time;Diadochokinesis;Percentage of Phonemes Correct;Patient Health Questionnaire-9;Quality of Life in the Dysarthric Speaker;Communicative Effectiveness Survey

Countries

Korea, Republic of

Contacts

Public ContactHanna Kim

National Rehabilitation Center

hanna94@korea.kr+82-2-901-1823

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026