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Not yet recruitingNCT06256835Updated Mar 15, 2024

Effect of Myofascial Release on Dysphagia in Parkinson's Patients

An interventional study of Rehabilitation treatment and Myofascial Release Therapy in Parkinson Disease, sponsored by Zeng Changhao. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Zeng Changhao · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
Read the detailed description

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.

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.
02

Conditions studied

  • Parkinson Disease

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    The experimental group

    Study lasts 21 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.

    Behavioral: Rehabilitation treatment · Behavioral: Myofascial Release Therapy

  • Active comparator
    The control group

    Study lasts 21 days for each patient. All patients are given rehabilitation treatment, five days a week, once a day, for 30-60 minutes each time.

    Behavioral: Rehabilitation treatment

Interventions

  • BehavioralRehabilitation treatment

    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.

  • BehavioralMyofascial Release Therapy

    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.

05

What researchers measure

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.

    Time frame: day 1 and day 21

Secondary outcomes

  1. Swallowing Quality of Life questionnaire

    Swallowing Quality of Life questionnaire was used to evaluate the quality of life, which consists of 44 items and divided into 11 main domains, including: overall satisfaction, understanding, diet, hydration, communication, respiratory issues, postoperative recovery, social impact, mental health, saliva control, and appearance. The maximum rough score was 220 points, which was converted into a standard percentage system in our study. As the scores increased, the quality of life was better.

    Time frame: day 1 and day 21

  2. patient health questionnaire-9

    The depression of the patients was evaluated with the patient health questionnaire-9. The scores ranged 0-27. As the scores increased, the severity of depression also increased.

    Time frame: day 1 and day 21

  3. Functional Oral Intake Scale

    During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The Functional Oral Intake Scale assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability. In general, the result below level 6 indicates unsafe for oral intake while level 6 and above indicates that eating via mouth can be safely conducted.

    Time frame: day 1 and day 21

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06256835
Lead sponsor
Zeng Changhao
Responsible party
Zeng Changhao (PI, People's Hospital of Zhengzhou University) — Sponsor-investigator
First posted
Feb 13, 2024
Start date
Apr 2024 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 15, 2024

Study contacts

Zhefeng Wang, Master
Contact
zhengzhouzhj@qq.com
19501376864
Weiji Zhao, Master
Contact
zwjww2009@163.com
17839973473
Nieto Luis, Master
principal investigator · Site Coordinator of United Medical Group located in Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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