Stroke Clinical Trial
Official title:
A Randomized Controlled Study to Explore the Effect of Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients
The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - age = 18 years; - meeting the diagnostic criteria of stroke; - any degree of dysphagia at admission; - steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment. - transferred out within three weeks of hospitalization in the neurology department. Exclusion Criteria: - complicated with other neurological diseases; - damaged mucosa or incomplete structure in nasopharynx; - tracheostomy tube plugged; - unfeasible to the support of parenteral nutrition; - simultaneously suffering from liver, kidney failure, tumors, or hematological diseases. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Copka Sonpashan |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rehabilitation Treatment Compliance Questionnaire | The Rehabilitation Treatment Compliance Questionnaire assesses patient compliance with rehabilitation treatment plans. It consists of 12 items that cover aspects such as the patient's understanding of the treatment plan, attitude towards treatment, compliance, and perception of rehabilitation outcomes. The scoring range for The Rehabilitation Treatment Compliance Questionnaire is typically from 12 to 60 points. A higher score indicates better understanding of the treatment plan, more positive attitude towards treatment, higher compliance with the treatment plan, and better perception of rehabilitation outcomes. |
day 1 and day 15 | |
Secondary | Patient Health Questionnaire-9 | The total score of the Patient Health Questionnaire-9 ranges from 0 to 27, with higher scores indicating more severe depression symptoms. | day 1 and day 15 | |
Secondary | Swallowing Quality of Life questionnaire | Swallowing Quality of Life questionnaire was used to evaluate the quality of life, which consists of 44 items and divided into 11 main domains, including: overall satisfaction, understanding, diet, hydration, communication, respiratory issues, postoperative recovery, social impact, mental health, saliva control, and appearance. The maximum rough score was 220 points, which was converted into a standard percentage system in our study. As the scores increased, the quality of life was better. | day 1 and day 15 |
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