- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06255756
Effect of Acupuncture Therapy on Dysphagic Parkinson's Patients
Effect of Acupuncture Therapy on Dysphagic Parkinson's Patients: A Randomized Controlled Study
Study Overview
Status
Conditions
Detailed Description
We are currently conducting a randomized controlled study in China, specifically in three hospitals' rehabilitation medicine departments, focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants.
The study lasted 42 days (6 weeks) for each participant. Specifically, our main focus is on the study of Lianquan, Shanglianquan (depression between the hyoid bone and the lower border of the mandible), Yifeng, Fengchi, Wangu, Fengfu, Yamen, Neidaying (depression of 1 inch below the anterior margin of the mandible), Jinjin, Yuye, posterior pharyngeal wall (both sides of the uvula).
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Weiji Zhao, Master
- Phone Number: 17839973473
- Email: zwjww2009@163.com
Study Contact Backup
- Name: Qianyun Lu, Master
- Phone Number: 15333866454
- Email: luqianyun@126.com
Study Locations
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Henan
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Zhenzhou, Henan, China, 450001
- Zheng Da yi Yuan Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age >18 years.
- Meeting the diagnostic criteria for Parkinson's disease.
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: routine treatment+swallowing rehabilitation training+acupuncture therapy
The experimental group was given routine treatment and swallowing rehabilitation training.
Moreover, the experimental group was given acupuncture therapy.
|
The whole acupuncture therapy was performed once daily for 5 days per week, including acupuncture needle and tongue needle. Acupuncture needle: Main acupoints: Lianquan, Shanglianquan (depression between the hyoid bone and the lower border of the mandible), Yifeng; Auxiliary acupoints: Fengchi, Wangu, Fengfu, Yamen, Neidaying (depression of 1 inch below the anterior margin of the mandible). Tongue needle (pricking): Acupoints: Jinjin, Yuye, posterior pharyngeal wall (both sides of the uvula). 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. Routine rehabilitation training was performed 30-45 minutes/time, 1-2 times/day, 5-7 days/week. Swallowing-related organ training involves various exercises targeting the lip, mandibular muscle, cheek, tongue muscle, soft palate, as well as exercises for vocal cord closure, laryngeal lifting, and pharyngeal muscle training. These exercises are performed for 5-15 minutes each session, 1-2 times per day, and 5-7 days per week. Sensory stimulation training is conducted using a self-made popsicle, where medical staff gently stimulate the patient's cheek, palatoquadrate, soft palate, posterior pharyngeal wall, tongue surface, and sublingual area repeatedly. Each session lasts 5-25 minutes, performed 1-3 times per day, and 3-7 days per week. Once the patient's swallowing function improves to a certain extent, allowing for safe oral intake, direct training or oral feeding training can be gradually introduced. |
Active Comparator: routine treatment+swallowing rehabilitation training
The control group was given routine treatment and swallowing rehabilitation training.
|
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. Routine rehabilitation training was performed 30-45 minutes/time, 1-2 times/day, 5-7 days/week. Swallowing-related organ training involves various exercises targeting the lip, mandibular muscle, cheek, tongue muscle, soft palate, as well as exercises for vocal cord closure, laryngeal lifting, and pharyngeal muscle training. These exercises are performed for 5-15 minutes each session, 1-2 times per day, and 5-7 days per week. Sensory stimulation training is conducted using a self-made popsicle, where medical staff gently stimulate the patient's cheek, palatoquadrate, soft palate, posterior pharyngeal wall, tongue surface, and sublingual area repeatedly. Each session lasts 5-25 minutes, performed 1-3 times per day, and 3-7 days per week. Once the patient's swallowing function improves to a certain extent, allowing for safe oral intake, direct training or oral feeding training can be gradually introduced. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Penetration-Aspiration Scale-liquid
Time Frame: Day 1 and Day 42
|
The Penetration-Aspiration Scale (PAS) was conducted under video fluoroscopic swallowing study. PAS 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 PAS scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration. In this assessment, we used 60% barium sulfate suspension A higher level of PAS indicated a severer dysphagia. |
Day 1 and Day 42
|
Penetration-Aspiration Scale-paste
Time Frame: Day 1 and Day 42
|
The Penetration-Aspiration Scale (PAS) was conducted under video fluoroscopic swallowing study. PAS 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 PAS scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration. In this assessment, we used 180% barium sulfate suspension A higher level of PAS indicated a severer dysphagia. |
Day 1 and Day 42
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Swallowing time
Time Frame: Day 1 and Day 42
|
The assessment was conducted under video fluoroscopic swallowing study.
A 60% barium sulfate suspension was mixed with different doses of thickening agents.
The liquid (60% barium sulfate suspension) was used.
A shorter time indicated better swallowing function.
|
Day 1 and Day 42
|
body mass index
Time Frame: Day 1 and Day 42
|
Patients' body mass index was assessed with the physical check, with the combination of height and body weight.
as kg/m^2, reference range: 18.5 kg/m2≤BMI<24 kg/m2.
|
Day 1 and Day 42
|
Serum Albumin
Time Frame: Day 1 and Day 42
|
Patients' Serum Albumin was assessed from the routine blood test, reference range: 35~50 g/L.Values below the reference range for these indicators indicated an unsatisfying nutritional status (risk of malnutrition).
|
Day 1 and Day 42
|
Prealbumin
Time Frame: Day 1 and Day 42
|
Patients' Prealbumin was assessed from the routine blood test, reference range: 200~400 mg/L.Values below the reference range for these indicators indicated an unsatisfying nutritional status (risk of malnutrition).
|
Day 1 and Day 42
|
Hemoglobin
Time Frame: Day 1 and Day 42
|
Patients' Hemoglobin was assessed from the routine blood test, reference range: males: 120~160 g/L, females: 110~150 g/L.
Values below the reference range for these indicators indicated an unsatisfying nutritional status (risk of malnutrition).
|
Day 1 and Day 42
|
Swallowing Quality of Life
Time Frame: Day 1 and Day 42
|
Swallowing Quality of Life (SWAL-QOL) is a questionnaire designed to evaluate the impact of swallowing problems on a patient's quality of life. It includes 44 items covering various aspects such as eating desire, food selection, communication, and mental health. The SWAL-QOL total score ranges from 0 to 100, with higher scores indicating better quality of life. Therefore, in this case, the higher the score, the better the individual's quality of life related to their swallowing function. |
Day 1 and Day 42
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nieto Luis, Master, Site Coordinator of United Medical Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Zhenjiu-Parkinson
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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