Acupuncture Technique for Restoring Consciousness on Post-stroke Dysphagia

Dysphagia Clinical Trial

Official title:

Clinical Effect of Acupuncture Technique for Restoring Consciousness Combined With Scalp Acupuncture on Post-stroke Dysphagia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06328582
• Other study ID #: Zhenjiu Post-stroke dysphagia
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Chao Phya Abhaibhubejhr Hospital
• Contact: Lavie Ce, Master
• Phone: 17695841016
• Email: zengxizdyfy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given Acupuncture Technique for Restoring Consciousness. Swallowing function will be compared before and after treatment.

Description:

This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given Acupuncture Technique for Restoring Consciousness. Swallowing function will be compared before and after treatment. Specifically, our main focus is on Neiguan, Renzhong and Sanyinjiao.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years.
• Meeting the diagnostic criteria for stroke.
• Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
• Water swallow test> Level 3.
• Stable vital signs, conscious, able to cooperate with assessment and treatment.

Exclusion Criteria:

• Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
• History of mental diseases or use of antipsychotics.
• Complicated with cognitive impairment or consciousness dysfunction.
• Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Behavioral:
• Routine rehabilitation training
Balance function training: Patients were instructed to achieve weight shift between the left and right sides of the balance bar in a standing position. Walking function training: based on hip, knee, and ankle control training, patients were instructed to take steps training. Core muscle strength training: Patients were instructed to maintain 3 minutes of training in Bridge-style movement. Functional training of daily living: including training on dressing and undressing, independent eating, painting, and writing.

Procedure:
• Acupuncture Technique for Restoring Consciousness combined with Scalp Acupuncture
Acupuncture Technique for Restoring Consciousness: Main acupoints: Neiguan (bilateral), Renzhong, Sanyinjiao (affected side) Additional acupoints: Fengchi, Wangu, Yifeng (bilateral), and posterior pharyngeal wall needling. Scalp Acupuncture Method: Based on the standard treatment lines for scalp acupuncture [17], select the anterior oblique line of vertex-temporal region, posterior oblique line of vertex-temporal region, and anterior line of temporal region (bilateral).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Copka Sonpashan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penetration-Aspiration Scale	The Penetration-Aspiration Scale was conducted under video fluoroscopic swallowing study. The scale is a standardized tool used to assess the safety of swallowing. The scale was developed to evaluate the entry of material into the airway (penetration) and the subsequent passage of material below the vocal folds (aspiration) during swallowing. The scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration.	day 1 and day 28
Secondary	Functional Oral Intake Scale	The scale reflects the patient's oral intake. Studies have shown that this scale can also serve as an independent measure of intake for post-stroke dysphagia patients. The scale is divided into 7 levels, with the level positively correlated with swallowing function. Level 7 indicates normal swallowing function.	day 1 and day 28
Secondary	Gugging Swallowing Screen	Gugging Swallowing Screen is a safe and simple bedside screening tool that consists of 2 testing parts. It can accurately assess the risk of aspiration and differentiate between different food consistencies. The scale can not only detect the risk of aspiration in patients but also guide their diet. The scale has a maximum score of 20, indicating normal swallowing function. The lower the score, the more severe the swallowing disorder.	day 1 and day 28