DysphagiaNCT06328582
Acupuncture Technique for Restoring Consciousness on Post-stroke Dysphagia
A study testing Routine rehabilitation training and Acupuncture Technique for Restoring Consciousness combined with Scalp Acupuncture in people with Dysphagia, run by Copka Sonpashan.
Trial summary
This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Routine rehabilitation training and Acupuncture Technique for Restoring Consciousness combined with Scalp Acupuncture
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- Meeting the diagnostic criteria for stroke.
- Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
- Water swallow test> Level 3.
- Stable vital signs, conscious, able to cooperate with assessment and treatment.
Who cannot join
- Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
- History of mental diseases or use of antipsychotics.
- Complicated with cognitive impairment or consciousness dysfunction.
- Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Effect of Acupuncture Technique for Restoring Consciousness Combined With Scalp Acupuncture on Post-stroke Dysphagia
This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given Acupuncture Technique for Restoring Consciousness. Swallowing function will be compared before and after treatment.
Read the detailed description
This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given Acupuncture Technique for Restoring Consciousness. Swallowing function will be compared before and after treatment.
Specifically, our main focus is on Neiguan, Renzhong and Sanyinjiao.
- Conditions
- Dysphagia
- Being tested
- Routine rehabilitation training, Acupuncture Technique for Restoring Consciousness combined with Scalp Acupuncture
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine rehabilitation trainingBehavioural
Balance function training: Patients were instructed to achieve weight shift between the left and right sides of the balance bar in a standing position.
Walking function training: based on hip, knee, and ankle control training, patients were instructed to take steps training.
Core muscle strength training: Patients were instructed to maintain 3 minutes of training in Bridge-style movement.
Functional training of daily living: including training on dressing and undressing, independent eating, painting, and writing.
Acupuncture Technique for Restoring Consciousness combined with Scalp AcupunctureProcedure or surgery
Acupuncture Technique for Restoring Consciousness:
Main acupoints: Neiguan (bilateral), Renzhong, Sanyinjiao (affected side) Additional acupoints: Fengchi, Wangu, Yifeng (bilateral), and posterior pharyngeal wall needling.
Scalp Acupuncture Method:
Based on the standard treatment lines for scalp acupuncture [17], select the anterior oblique line of vertex-temporal region, posterior oblique line of vertex-temporal region, and anterior line of temporal region (bilateral).
| Study group | Role | What they receive |
|---|---|---|
| routine treatment+Acupuncture Technique for Restoring Consciousness Combined with Scalp Acupuncture | Experimental | The experimental group was given routine treatment. Moreover, the experimental group will receive Acupuncture Technique for Restoring Consciousness. Receives: Behavioral: Routine rehabilitation training; Procedure: Acupuncture Technique for Restoring Consciousness combined with Scalp Acupuncture |
| routine treatment | Active comparator | The experimental group was given routine treatment. Receives: Behavioral: Routine rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration-Aspiration Scale
The Penetration-Aspiration Scale was conducted under video fluoroscopic swallowing study. The scale is a standardized tool used to assess the safety of swallowing. The scale was developed to evaluate the entry of material into the airway (penetration) and the subsequent passage of material below the vocal folds (aspiration) during swallowing. The scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration.
Measured: day 1 and day 28
Secondary outcomes (2)
Functional Oral Intake Scale
The scale reflects the patient's oral intake. Studies have shown that this scale can also serve as an independent measure of intake for post-stroke dysphagia patients. The scale is divided into 7 levels, with the level positively correlated with swallowing function. Level 7 indicates normal swallowing function.
Measured: day 1 and day 28
Gugging Swallowing Screen
Gugging Swallowing Screen is a safe and simple bedside screening tool that consists of 2 testing parts. It can accurately assess the risk of aspiration and differentiate between different food consistencies. The scale can not only detect the risk of aspiration in patients but also guide their diet. The scale has a maximum score of 20, indicating normal swallowing function. The lower the score, the more severe the swallowing disorder.
Measured: day 1 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copka Sonpashan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Copka Sonpashan, Chao Phya Abhaibhubejhr Hospital
- Investigators
- Nieto Luis, Master, Study chair, Site Coordinator of United Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328582
- Sponsor's protocol ID
- Zhenjiu Post-stroke dysphagia
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Acupuncture Technique for Restoring Consciousness Combined With Scalp Acupuncture on Post-stroke Dysphagia
- ClinicalTrials.gov ID
- NCT06328582
- Acronym / sponsor ID
- Zhenjiu Post-stroke dysphagia
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copka SonpashanOther government
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given Acupuncture Technique for Restoring Consciousness. Swallowing function will be compared before and after treatment.
Detailed description
This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given Acupuncture Technique for Restoring Consciousness. Swallowing function will be compared before and after treatment.
Specifically, our main focus is on Neiguan, Renzhong and Sanyinjiao.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine treatment+Acupuncture Technique for Restoring Consciousness Combined with Scalp Acupuncture | Experimental | Behavioral: Routine rehabilitation training, Procedure: Acupuncture Technique for Restoring Consciousness combined with Scalp AcupunctureThe experimental group was given routine treatment. Moreover, the experimental group will receive Acupuncture Technique for Restoring Consciousness. |
| routine treatment | Active comparator | Behavioral: Routine rehabilitation trainingThe experimental group was given routine treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years.
- Meeting the diagnostic criteria for stroke.
- Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
- Water swallow test> Level 3.
- Stable vital signs, conscious, able to cooperate with assessment and treatment.
Key exclusion criteria (4 listed)
- Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
- History of mental diseases or use of antipsychotics.
- Complicated with cognitive impairment or consciousness dysfunction.
- Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine rehabilitation trainingBalance function training: Patients were instructed to achieve weight shift between the left and right sides of the balance bar in a standing position. Walking function training: based on hip, knee, and ankle control training, patients were instructed to take steps training. Core muscle strength training: Patients were instructed to maintain 3 minutes of training in Bridge-style movement. Functional training of daily living: including training on dressing and undressing, independent eating, painting, and writing. | Behavioural | routine treatment, routine treatment+Acupuncture Technique for Restoring Consciousness Combined with Scalp Acupuncture |
| Acupuncture Technique for Restoring Consciousness combined with Scalp AcupunctureAcupuncture Technique for Restoring Consciousness: Main acupoints: Neiguan (bilateral), Renzhong, Sanyinjiao (affected side) Additional acupoints: Fengchi, Wangu, Yifeng (bilateral), and posterior pharyngeal wall needling. Scalp Acupuncture Method: Based on the standard treatment lines for scalp acupuncture [17], select the anterior oblique line of vertex-temporal region, posterior oblique line of vertex-temporal region, and anterior line of temporal region (bilateral). | Procedure or surgery | routine treatment+Acupuncture Technique for Restoring Consciousness Combined with Scalp Acupuncture |
Primary outcome
Penetration-Aspiration Scale
Time frame: day 1 and day 28
The Penetration-Aspiration Scale was conducted under video fluoroscopic swallowing study. The scale is a standardized tool used to assess the safety of swallowing. The scale was developed to evaluate the entry of material into the airway (penetration) and the subsequent passage of material below the vocal folds (aspiration) during swallowing. The scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration.
2 secondary outcomes
Functional Oral Intake Scale
Time frame: day 1 and day 28
Gugging Swallowing Screen
Time frame: day 1 and day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieto Luis, Master study chair
Site Coordinator of United Medical Group
Questions about this trial
What is this clinical trial studying?
A study testing Routine rehabilitation training and Acupuncture Technique for Restoring Consciousness combined with Scalp Acupuncture in people with Dysphagia, run by Copka Sonpashan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lavie Ce, Master (17695841016, zengxizdyfy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration-Aspiration Scale (time frame: day 1 and day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.