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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06303895
Other study ID # Acu-PKS-new
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date June 2024

Study information

Verified date March 2024
Source Ahmadu Bello University Teaching Hospital
Contact Lavie Ce, Master
Phone 15333828388
Email zenghongjixx@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is 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.


Description:

This study is 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Routine 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 rehabilitation training
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, 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.
Procedure:
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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Muhammad

Outcome

Type Measure Description Time frame Safety issue
Primary Penetration-Aspiration Scale-liquid 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 Day 1 and Day 42
Primary Penetration-Aspiration Scale-paste 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. Day 1 and Day 42
Secondary Swallowing time 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
Secondary body mass index 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
Secondary Serum Albumin 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
Secondary Prealbumin 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
Secondary Hemoglobin 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
Secondary Swallowing Quality of Life 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
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