Acupuncture Technique for Restoring Consciousness on Post-stroke Dysphagia

NCT06328582 | Not Yet Recruiting

• 1 other identifier: Zhenjiu Post-stroke dysphagia
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Functional Oral Intake Scale

  day 1 and day 28

• Gugging Swallowing Screen

  day 1 and day 28

Study Arms (2)

routine treatment+Acupuncture Technique for Restoring Consciousness Combined with Scalp Acupuncture

EXPERIMENTAL

The experimental group was given routine treatment. Moreover, the experimental group will receive Acupuncture Technique for Restoring Consciousness.

Behavioral: Routine rehabilitation training; Procedure: Acupuncture Technique for Restoring Consciousness combined with Scalp Acupuncture

routine treatment

ACTIVE COMPARATOR

The experimental group was given routine treatment.

Behavioral: Routine rehabilitation training

Interventions

Routine rehabilitation training BEHAVIORAL

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.

routine treatment; routine treatment+Acupuncture Technique for Restoring Consciousness Combined with Scalp Acupuncture

Acupuncture Technique for Restoring Consciousness combined with Scalp Acupuncture PROCEDURE

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).

routine treatment+Acupuncture Technique for Restoring Consciousness Combined with Scalp Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copka Sonpashan: lead

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  STUDY CHAIR

Central Study Contacts

Lavie Ce, Master

CONTACT

17695841016; zengxizdyfy@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Research Director

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 25, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03