Dysphagia Clinical Trial
Official title:
How Acupuncture Therapy Improves Dysphagia in Parkinson's Patients: A Randomized Controlled Study
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Muhammad |
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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