Back to resultsStudy on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke
Primary Purpose
Dysphagia, Stroke, Oral Phase
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Conventional rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring Dysphagia, stroke, cortical swallowing network, Oral Phase
Eligibility Criteria
Inclusion Criteria: 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; 40 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. Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acupuncture rehabilitation group
Conventional rehabilitation group
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Oral functional score
To assess participants' oral swallowing function
Secondary Outcome Measures
Surface electromyography
To assess the swallowing muscle activity
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
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.
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).
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
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.
Full Information
NCT ID
NCT05982977
First Posted
August 1, 2023
Last Updated
August 18, 2023
Sponsor
Qingqing Zhang
Collaborators
Fujian University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05982977
Brief Title
Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke
Official Title
Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training to Regulate the Cortical Swallowing Network in Oral Dysphagia of Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qingqing Zhang
Collaborators
Fujian University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Stroke, Oral Phase
Keywords
Dysphagia, stroke, cortical swallowing network, Oral Phase
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture rehabilitation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional rehabilitation group
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
The patient was placed in a supine position, selected Lianquan, Fengchi, and acupoints.
Intervention Type
Behavioral
Intervention Name(s)
Conventional rehabilitation
Intervention Description
swallowing training included breathing training, masticatory muscle training, oral movement training and feeding training.
Primary Outcome Measure Information:
Title
Oral functional score
Description
To assess participants' oral swallowing function
Time Frame
4 weeks (Before and after intervation)
Secondary Outcome Measure Information:
Title
Surface electromyography
Description
To assess the swallowing muscle activity
Time Frame
4 weeks (Before and after intervation)
Title
Water swallowing test (WST)
Description
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
Time Frame
4 weeks (Before and after intervation)
Title
Standardized Swallowing Assessment (SSA)
Description
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.
Time Frame
4 weeks (Before and after intervation)
Title
Functional Oral Intake Scale (FOIS)
Description
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).
Time Frame
4 weeks (Before and after intervation)
Title
Teacher salivation rating (TDS)
Description
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
Time Frame
4 weeks (Before and after intervation)
Title
Swallowing Related Daily Quality of Life Scale (SWAL-QOL)
Description
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.
Time Frame
4 weeks (Before and after intervation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
40 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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Zhang
Phone
18150019719
Email
2017013@fjtcm.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingqing Zhang
Organizational Affiliation
Fujian University of Traditional Chinese Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke
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