NCT06328296

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable parkinson-disease

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

March 10, 2024

Last Update Submit

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

EXPERIMENTAL

Study 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.

Behavioral: Rehabilitation treatmentBehavioral: Myofascial Release Therapy

Rehabilitation treatment

ACTIVE COMPARATOR

Study 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.

Behavioral: Rehabilitation treatment

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.

Rehabilitation treatmentRehabilitation treatment+Myofascial 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.

Rehabilitation treatment+Myofascial Release Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

MeSH Terms

Conditions

Parkinson Disease

Interventions

RehabilitationMyofascial Release Therapy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesPhysical Therapy Modalities

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