Impact of Myofascial Release on Dysphagia in Parkinson's Disease Patients
A Randomized Controlled Study to Explore Effect of Myofascial Release on Dysphagia in Parkinson's Patients
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Parkinson's Patients. The main question it aims to answer is: • Can Myofascial Release Therapy improve swallowing function in Parkinson's Patients? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Apr 2024
Shorter than P25 for not_applicable parkinson-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2024
CompletedFirst Posted
Study publicly available on registry
March 25, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 25, 2024
March 1, 2024
8 months
March 10, 2024
March 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Penetration-Aspiration Scale
Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. The scores ranged 1 point to 8 points. As the level increased, the severity of dysphagia also increased
day 1 and day 15
Secondary Outcomes (3)
Swallowing Quality of Life questionnaire
day 1 and day 15
patient health questionnaire-9
day 1 and day 15
Functional Oral Intake Scale
day 1 and day 15
Study Arms (2)
Rehabilitation treatment+Myofascial Release Therapy
EXPERIMENTALStudy lasts 15 days for each patient. All patients are given rehabilitation treatment.The experimental group was given the Myofascial Release Therapy, five days a week, once a day, for 30-60 minutes each time.
Rehabilitation treatment
ACTIVE COMPARATORStudy lasts 15 days for each patient. All patients are given rehabilitation treatment, five days a week, once a day, for 30-60 minutes each time.
Interventions
Both groups are given rehabilitation treatment. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.
Myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. It involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. Myofascial release therapy is commonly used to treat muscle spasms, chronic pain, skeletal and joint issues, among others.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
- Complicated with cognitive impairment or consciousness dysfunction.
- Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
- Complicated with severe liver and kidney failure, tumors, or hematological disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Copka Sonpashanlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- The Research Director
Study Record Dates
First Submitted
March 10, 2024
First Posted
March 25, 2024
Study Start
April 1, 2024
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
March 25, 2024
Record last verified: 2024-03