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Clinical Trials/KCT0008505
KCT0008505
Not yet recruiting
未知

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

Korea Technology & Information Promotion Agency for SMEs0 sites68 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Korea Technology & Information Promotion Agency for SMEs
Enrollment
68
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional Study
Sex
All

Investigators

Sponsor
Korea Technology & Information Promotion Agency for SMEs

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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