Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT06255756
Status:
WITHDRAWN
Last Update Posted:
2024-03-06
First Post:
2024-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Acupuncture Therapy on Dysphagic Parkinson's Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'ethical issues', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-02', 'studyFirstSubmitDate': '2024-02-04', 'studyFirstSubmitQcDate': '2024-02-04', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Penetration-Aspiration Scale-liquid', 'timeFrame': 'Day 1 and Day 42', 'description': '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.\n\nIn this assessment, we used 60% barium sulfate suspension A higher level of PAS indicated a severer dysphagia.'}, {'measure': 'Penetration-Aspiration Scale-paste', 'timeFrame': 'Day 1 and Day 42', 'description': '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.\n\nIn this assessment, we used 180% barium sulfate suspension A higher level of PAS indicated a severer dysphagia.'}], 'secondaryOutcomes': [{'measure': 'Swallowing time', 'timeFrame': 'Day 1 and Day 42', 'description': '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.'}, {'measure': 'body mass index', 'timeFrame': 'Day 1 and Day 42', 'description': "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."}, {'measure': 'Serum Albumin', 'timeFrame': 'Day 1 and Day 42', 'description': "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)."}, {'measure': 'Prealbumin', 'timeFrame': 'Day 1 and Day 42', 'description': "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)."}, {'measure': 'Hemoglobin', 'timeFrame': 'Day 1 and Day 42', 'description': "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)."}, {'measure': 'Swallowing Quality of Life', 'timeFrame': 'Day 1 and Day 42', 'description': "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.\n\nThe 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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysphagia']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThe 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>18 years.\n* Meeting the diagnostic criteria for Parkinson's disease.\n* Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.\n* Water swallow test\\> Level 3.\n* Stable vital signs, conscious, able to cooperate with assessment and treatment.\n\nExclusion Criteria:\n\n* Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.\n* History of mental diseases or use of antipsychotics.\n* Complicated with cognitive impairment or consciousness dysfunction.\n* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases."}, 'identificationModule': {'nctId': 'NCT06255756', 'briefTitle': "Effect of Acupuncture Therapy on Dysphagic Parkinson's Patients", 'organization': {'class': 'OTHER', 'fullName': "People's Hospital of Zhengzhou University"}, 'officialTitle': "Effect of Acupuncture Therapy on Dysphagic Parkinson's Patients: A Randomized Controlled Study", 'orgStudyIdInfo': {'id': 'Zhenjiu-Parkinson'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'routine treatment+swallowing rehabilitation training+acupuncture therapy', 'description': 'The experimental group was given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy.', 'interventionNames': ['Behavioral: Routine rehabilitation training', 'Behavioral: Swallowing rehabilitation training', 'Procedure: Acupuncture therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'routine treatment+swallowing rehabilitation training', 'description': 'The control group was given routine treatment and swallowing rehabilitation training.', 'interventionNames': ['Behavioral: Routine rehabilitation training', 'Behavioral: Swallowing rehabilitation training']}], 'interventions': [{'name': 'Routine rehabilitation training', 'type': 'BEHAVIORAL', 'description': 'Balance function training: Patients were instructed to achieve weight shift between the left and right sides of the balance bar in a standing position.\n\nWalking function training: based on hip, knee, and ankle control training, patients were instructed to take steps training.\n\nCore muscle strength training: Patients were instructed to maintain 3 minutes of training in Bridge-style movement.\n\nFunctional training of daily living: including training on dressing and undressing, independent eating, painting, and writing.\n\nRoutine rehabilitation training was performed 30-45 minutes/time, 1-2 times/day, 5-7 days/week.', 'armGroupLabels': ['routine treatment+swallowing rehabilitation training', 'routine treatment+swallowing rehabilitation training+acupuncture therapy']}, {'name': 'Swallowing rehabilitation training', 'type': 'BEHAVIORAL', 'description': "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.\n\nSensory 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.\n\nOnce 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.", 'armGroupLabels': ['routine treatment+swallowing rehabilitation training', 'routine treatment+swallowing rehabilitation training+acupuncture therapy']}, {'name': 'Acupuncture therapy', 'type': 'PROCEDURE', 'description': 'The whole acupuncture therapy was performed once daily for 5 days per week, including acupuncture needle and tongue needle.\n\nAcupuncture needle:\n\nMain 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).\n\nTongue needle (pricking):\n\nAcupoints: Jinjin, Yuye, posterior pharyngeal wall (both sides of the uvula).', 'armGroupLabels': ['routine treatment+swallowing rehabilitation training+acupuncture therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450001', 'city': 'Zhenzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Zheng Da yi Yuan Hospital'}], 'overallOfficials': [{'name': 'Nieto Luis, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Site Coordinator of United Medical Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeng Changhao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Zeng Changhao', 'investigatorAffiliation': "People's Hospital of Zhengzhou University"}}}}