Effect of Intermittent Oro-esophageal Tube Feeding on Dysphagic Stroke Survivors

Not Applicable

Withdrawn

• Conditions: Stroke
• Interventions: Behavioral: comprehensive rehabilitation therapy; Device: Intermittent Oro-esophageal Tube Feeding; Device: Nasogastric Tube Feeding

• Registration Number: NCT06228183
• Lead Sponsor: Zeng Changhao

Brief Summary

The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:

* Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors?

* Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 21 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.

Detailed Description

Stroke is happening increasingly more. The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:

* Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors?

* Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 21 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.

Study Timeline

• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-29
• Study Start: 2024-01-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-02
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the experimental group	comprehensive rehabilitation therapy	Study lasts 21 days for each patient. The patients were given comprehensive rehabilitation therapy. The experimental group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding.
the experimental group	Intermittent Oro-esophageal Tube Feeding	Study lasts 21 days for each patient. The patients were given comprehensive rehabilitation therapy. The experimental group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding.
the control group	comprehensive rehabilitation therapy	Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation. The control group was provided the support of enteral nutrition by Nasogastric Tube Feeding.
the control group	Nasogastric Tube Feeding	Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation. The control group was provided the support of enteral nutrition by Nasogastric Tube Feeding.

Primary Outcome Measures

Name	Time	Method
Social Functioning Scale	day 1 and day 21	The Social Functioning Scale includes multiple subscales, and the score range is generally 0-100. Higher scores indicate better social functioning, while lower scores indicate limited social functioning or problems.

Secondary Outcome Measures

Name	Time	Method
Depression	day 1 and day 21	The depression was assessed using the Patient Health Questionnaire-9, with aspects including mood swings, optimism, sleep quality, appetite, etc. The total score ranged from 0 to 27, which was positively correlated with potential depression. In the previous study, the scale demonstrated a Cronbach's α-coefficient of 0.913.
Social Support Questionnaire	day 1 and day 21	Social Support Questionnaire's score range is generally 0-100. Generally, higher scores are better and indicate more social support.
Anxiety	day 1 and day 21	The anxiety was assessed using the Generalized Anxiety Disorder-7, including items related to fear, worry, attention, etc. The total score ranged from 0 to 21, which was positively correlated with potential anxiety. In the previous study, the scale demonstrated a Cronbach's α-coefficient of 0.879.

Trial Locations

Locations (1)

Zheng da yi fu yuan hospital; 🇨🇳 Zhengzhou, Henan, China