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

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ClinicalTrials.gov Identifier: NCT05982977
Recruitment Status : Not yet recruiting
First Posted : August 9, 2023
Last Update Posted : August 22, 2023
Sponsor:
Collaborator:
Fujian University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Qingqing Zhang, Fujian University of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE August 1, 2023
First Posted Date  ICMJE August 9, 2023
Last Update Posted Date August 22, 2023
Estimated Study Start Date  ICMJE September 30, 2023
Estimated Primary Completion Date August 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2023)		 Oral functional score [ Time Frame: 4 weeks (Before and after intervation) ]
To assess participants' oral swallowing function
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2023)
  • Surface electromyography [ Time Frame: 4 weeks (Before and after intervation) ]
    To assess the swallowing muscle activity
  • Water swallowing test (WST) [ Time Frame: 4 weeks (Before and after intervation) ]
    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
  • Standardized Swallowing Assessment (SSA) [ Time Frame: 4 weeks (Before and after intervation) ]
    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.
  • Functional Oral Intake Scale (FOIS) [ Time Frame: 4 weeks (Before and after intervation) ]
    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).
  • Teacher salivation rating (TDS) [ Time Frame: 4 weeks (Before and after intervation) ]
    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
  • Swallowing Related Daily Quality of Life Scale (SWAL-QOL) [ Time Frame: 4 weeks (Before and after intervation) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2023)
  • Surface electromyography [ Time Frame: 4 weeks (Before and after intervation) ]
    To assess the swallowing muscle activity
  • Water swallowing test (WST) [ Time Frame: 4 weeks (Before and after intervation) ]
    The severity of dysphagia was assessed by the WST
  • Standardized Swallowing Assessment (SSA) [ Time Frame: 4 weeks (Before and after intervation) ]
    To assess the severity of swallowing
  • Functional Oral Intake Scale (FOIS) [ Time Frame: 4 weeks (Before and after intervation) ]
    To assess the condition of swallowing
  • Teacher salivation rating (TDS) [ Time Frame: 4 weeks (Before and after intervation) ]
    Assess salivation
  • Swallowing Related Daily Quality of Life Scale (SWAL-QOL) [ Time Frame: 4 weeks (Before and after intervation) ]
    Assessed patients' quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke
Official Title  ICMJE Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training to Regulate the Cortical Swallowing Network in Oral Dysphagia of Stroke
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
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
Condition  ICMJE
  • Dysphagia
  • Stroke
  • Oral Phase
Intervention  ICMJE
  • Other: Acupuncture
    The patient was placed in a supine position, selected Lianquan, Fengchi, and acupoints.
  • Behavioral: Conventional rehabilitation
    swallowing training included breathing training, masticatory muscle training, oral movement training and feeding training.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Acupuncture
  • 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
    Intervention: Behavioral: Conventional rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2023)		 56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2025
Estimated Primary Completion Date August 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qingqing Zhang 18150019719 2017013@fjtcm.edu.cn
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05982977
Other Study ID Numbers  ICMJE 2022J01880
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Qingqing Zhang, Fujian University of Traditional Chinese Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Qingqing Zhang
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Fujian University of Traditional Chinese Medicine
Investigators  ICMJE
Principal Investigator: Qingqing Zhang Fujian University of Traditional Chinese Medicine
PRS Account Fujian University of Traditional Chinese Medicine
Verification Date August 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP