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

NCT05982977 | Unknown DMC

• 1 other identifier: 2022J01880
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dysphagia; Stroke; Oral Phase

Keywords

Dysphagia; stroke; cortical swallowing network; Oral Phase

Outcome Measures

Primary Outcomes (1)

• Oral functional score

  To assess participants' oral swallowing function

  4 weeks (Before and after intervation)

Secondary Outcomes (6)

• Surface electromyography

  4 weeks (Before and after intervation)

• Water swallowing test (WST)

  4 weeks (Before and after intervation)

• Standardized Swallowing Assessment (SSA)

  4 weeks (Before and after intervation)

• Functional Oral Intake Scale (FOIS)

  4 weeks (Before and after intervation)

• Teacher salivation rating (TDS)

  4 weeks (Before and after intervation)

Study Arms (2)

Acupuncture rehabilitation group

EXPERIMENTAL

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

Conventional rehabilitation group

ACTIVE COMPARATOR

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

Interventions

Acupuncture OTHER

The patient was placed in a supine position, selected Lianquan, Fengchi, and acupoints.

Acupuncture rehabilitation group

Conventional rehabilitation BEHAVIORAL

swallowing training included breathing training, masticatory muscle training, oral movement training and feeding training.

Conventional rehabilitation group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Oral dysphagia caused by stroke;
• Currently diet is restricted, FOIS score is 5 or less; WST score 3 or above;
• 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;
• to 75 years old;
• Conscious and stable vital signs;
• Convalescent patients with stroke course and dysphagia duration between 1-6 months;
• Voluntary participation and informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Qingqing Zhang: lead
• Fujian University of Traditional Chinese Medicine: collaborator

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Qingqing Zhang

  Fujian University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingqing Zhang

CONTACT

18150019719; 2017013@fjtcm.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since acupuncture intervention could not blind subjects and investigators, evaluators and statisticians were secretly grouped to avoid measurement bias as much as possible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: September 30, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share