Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke

Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training to Regulate the Cortical Swallowing Network in Oral Dysphagia of Stroke

Up to 84% of patients after stroke are accompanied by dysphagia, of which 53% are oral dysphagia. The oral phase is the initial phase of swallowing activity and the only stage of swallowing that is completely discretionary. Swallowing activity in the oral stage is not only related to the formation and push of food pellets, but also affects the continuity between the transition from spontaneous swallowing to the swallowing reflex.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Dysphagia; Oral Phase
• Intervention / Treatment: Other: Acupuncture; Behavioral: Conventional rehabilitation

Detailed Description

After stroke, patients are prone to oral dysphagia, poor control of food masses and liquids in the mouth, resulting in food spillover, residual and premature overflow, resulting in dehydration, malnutrition, aspiration, pneumonia and other serious consequences, which greatly reduce the eating safety and quality of life of patients after stroke. Therefore, the rehabilitation of oral swallowing function is a way for patients with swallowing disorder after stroke to return to society and improve their quality of life. Previous studies have found that acupuncture is an effective intervention to improve swallowing disorder in oral stage after stroke. Whether acupuncture promotes the improvement of swallowing function in oral stage by regulating the synergic activity of cortical swallowing network and muscle group has not been fully clarified.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qingqing Zhang; Phone Number: 18150019719; Email: 2017013@fjtcm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients meeting the diagnostic criteria for acute ischemic stroke established by the Neurology Society of the Chinese Medical Association and confirmed by craniocerebral CT or MRI;
2. Oral dysphagia caused by stroke;
3. Currently diet is restricted, FOIS score is 5 or less; WST score 3 or above;
4. MoCA score of 21 or above, able to understand and follow simple instructions from the treatment staff, able to cooperate and willing to undergo examination and treatment;
5. 40 to 75 years old;
6. Conscious and stable vital signs;
7. Convalescent patients with stroke course and dysphagia duration between 1-6 months;
8. Voluntary participation and informed consent.

Exclusion Criteria:

1. Patients with dysphagia not caused by stroke or non-stroke oral dysphagia;
2. Previous history of stroke or dysphagia;
3. Patients with serious primary diseases or mental disorders of other systems;
4. Suffering from various bleeding prone diseases;
5. Severe needle fainting;
6. People with metal implants.
7. Patients with poor compliance are not treated as prescribed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture rehabilitation group; Acupuncture rehabilitation intervention was given on the basis of conventional rehabilitation therapy.Disinfected with 75% alcohol and applied the needles at a depth of 25-35mm. Acupuncture stimulation of Lianquan (CV23) and Fengchi (GB20). The needles were retained for 30 minutes/time, once a day, and 5 days/week for a total of 4 weeks.	Other: Acupuncture; The patient was placed in a supine position, selected Lianquan, Fengchi, and acupoints.
Active Comparator: Conventional rehabilitation group; This group participants would take swallowing training 30 minutes/time, once a day, 5 days/week, a total of 4 weeks of intervention. At the same time, stroke basic treatment, nutritional support and other symptomatic treatment	Behavioral: Conventional rehabilitation; swallowing training included breathing training, masticatory muscle training, oral movement training and feeding training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral functional score	To assess participants' oral swallowing function	4 weeks (Before and after intervation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface electromyography	To assess the swallowing muscle activity	4 weeks (Before and after intervation)
Water swallowing test (WST)	The severity of dysphagia was assessed by the WST. Level 1: Can drink 30ml water successfully within 5 seconds; Level 2: Drink water more than 2 times, can swallow without choking. Level 3: Can be drunk once, but cough. Level 4: swallowed more than twice, but with choking. Level 5: Frequent choking, unable to swallow all. Normal: Level 1, Suspicious: Level 1, more than 5 seconds or level 2; Abnormal: Level 3 to 5	4 weeks (Before and after intervation)
Standardized Swallowing Assessment (SSA)	To assess the severity of swallowing. The lowest score on this scale is 18 points, the highest score is 46 points, the higher the score, the worse the swallowing function.	4 weeks (Before and after intervation)
Functional Oral Intake Scale (FOIS)	To assess the condition of swallowing. The grade of FOIS was categorized as level 1 to 3 (poor FOIS: tube feeding), levels 4 and 5 (moderate FOIS: total oral diet requiring special preparation) or levels 6 and 7 (good FOIS: total oral diet without special preparation).	4 weeks (Before and after intervation)
Teacher salivation rating (TDS)	Assess salivation. Level 1: No salivation; Level 2: Small amount, occasional flow. Level 3: Stream from time to time; Level 4: Flow frequently, but not linearly; Level 5: Flow in line, chest often wet	4 weeks (Before and after intervation)
Swallowing Related Daily Quality of Life Scale (SWAL-QOL)	Assessed patients' quality of life. The SWAL-QOL scale consists of 11 dimensions, covering 44 items, of which 10 dimensions measure patients' quality of life and one dimension measures patients' swallowing symptoms. The 10 quality of life dimensions included 30 items, of which 8 (25 items in total) were related to swallowing, including psychological burden, eating time, appetite, food choice, verbal communication, fear of eating, mental health, and social interaction: the common dimension had 2 (5 items in total), including fatigue and sleep. The dimension of swallowing symptoms included 14 items. The SWAL-OOL scale was scored by Likert scoring method. The higher the score of five levels (1-5 respectively), the better the quality of life.	4 weeks (Before and after intervation)

Collaborators and Investigators

• Sponsor: Qingqing Zhang
• Collaborators: Fujian University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Qingqing Zhang, Fujian University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: stroke; Dysphagia; cortical swallowing network; Oral Phase
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Stroke; Deglutition Disorders
• Other Study ID Numbers: 2022J01880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No