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

• Sponsor: Qingqing Zhang (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05982977
• Collaborator: Fujian University of Traditional Chinese Medicine (Other)
• Enrollment: 56
• Arms: 2
• Anticipated Duration (Months): 24.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Phase Dysphagia	Other: Acupuncture; Behavioral: Conventional rehabilitation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This study was a parallel, randomized controlled trial. Qualified subjects were numbered according to the inclusion order and randomly assigned to the swallowing training treatment group and the acupuncture combined swallowing training treatment group in a 1:1 ratio.This study was a parallel, randomized controlled trial. Qualified subjects were numbered according to the inclusion order and randomly assigned to the swallowing training treatment group and the acupuncture combined swallowing training treatment group in a 1:1 ratio.
• Masking: Single (Outcomes Assessor)
• Masking Description: Since acupuncture intervention could not blind subjects and investigators, evaluators and statisticians were secretly grouped to avoid measurement bias as much as possible
• Primary Purpose: Treatment
• Official Title: Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training to Regulate the Cortical Swallowing Network in Oral Dysphagia of Stroke
• Anticipated Study Start Date: Jul 30, 2023
• Anticipated Primary Completion Date: Aug 1, 2025
• Anticipated Study Completion Date: Aug 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Oral functional score [4 weeks (Before and after intervation)]

   To assess participants' oral swallowing function

Secondary Outcome Measures

1. Surface electromyography [4 weeks (Before and after intervation)]

   To assess the swallowing muscle activity

2. Water swallowing test (WST) [4 weeks (Before and after intervation)]

   The severity of dysphagia was assessed by the WST

3. Standardized Swallowing Assessment (SSA) [4 weeks (Before and after intervation)]

   To assess the severity of swallowing

4. Functional Oral Intake Scale (FOIS) [4 weeks (Before and after intervation)]

   To assess the condition of swallowing

5. Teacher salivation rating (TDS) [4 weeks (Before and after intervation)]

   Assess salivation

6. Swallowing Related Daily Quality of Life Scale (SWAL-QOL) [4 weeks (Before and after intervation)]

   Assessed patients' quality of life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Qingqing Zhang
• Fujian University of Traditional Chinese Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qingqing Zhang, Lecturer, Fujian University of Traditional Chinese Medicine
• ClinicalTrials.gov Identifier: NCT05982977
• Other Study ID Numbers: 2022J01880
• First Posted: Aug 9, 2023
• Last Update Posted: Aug 9, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Qingqing Zhang, Lecturer, Fujian University of Traditional Chinese Medicine: Oral Phase Dysphagia , Stroke , cortical swallowing network
• Additional relevant MeSH terms: Deglutition Disorders

Study Results

No Results Posted as of Aug 9, 2023