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Clinical Trials/NCT06211426
NCT06211426
Withdrawn
N/A

A Randomized Controlled Study to Explore The Efficacy of Stellate Ganglion Block in Children With Cerebral Palsy and Dysphagia

Zeng Changhao1 site in 1 countryJanuary 15, 2024
ConditionsCerebral Palsy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Zeng Changhao
Locations
1
Primary Endpoint
Penetration-Aspiration Scale
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Detailed Description

Cerebral palsy is a common non-progressive clinical condition characterized by motor disorders and abnormal postures, which significantly impact the quality of life of affected children. Swallowing dysfunction is a common complication in children with Cerebral palsy , affecting their daily eating and communication skills, and hindering their nutritional development and social interaction. Stellate ganglion block has shown certain efficacy in improving swallowing function in children with Cerebral palsy. However, there is limited research on the effects of stellate ganglion block treatment on swallowing dysfunction in children with Cerebral palsy. Therefore, this study aims to explore this topic and provide scientific evidence for its clinical application. The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are: • Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Registry
clinicaltrials.gov
Start Date
January 15, 2024
End Date
April 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zeng Changhao
Responsible Party
Sponsor Investigator
Principal Investigator

Zeng Changhao

Head of R&D

People's Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

  • meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation;
  • age between 4 to 7 years;
  • diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy;

Exclusion Criteria

  • with dysphagia caused by other diseases or factors;
  • with progressive neurological disease or degenerative neurological disease;
  • with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms;
  • with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract;
  • with poor compliance.

Outcomes

Primary Outcomes

Penetration-Aspiration Scale

Time Frame: day 1 and day 20

On the day 1 and day 20, Penetration-Aspiration Scale is used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food enter the airway and caused penetration or aspiration during the swallowing process. As the level increases, the severity of dysphagia also increases.

Secondary Outcomes

  • Swallowing duration(day 1 and day 20)
  • Functional Oral Intake Scale(day 1 and day 20)

Study Sites (1)

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