Clinical trial NCT06256861: Effect of Myofascial Release on Dysphagia in Patients With Traumatic Brain Injury
Official title: A Randomized Controlled Study to Explore Effect of Myofascial Release on Dysphagia in Patients With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Traumatic Brain injured Survivors. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured Survivors? 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.

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 Traumatic Brain injured Survivors. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured Survivors? 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.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury.
* presence of no contraindication for enteral nutrition;
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to Myofascial Release;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.

Primary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 21
Secondary outcomes:
measure: Swallowing Quality of Life questionnaire
timeFrame: day 1 and day 21
measure: Patient health questionnaire-9
timeFrame: day 1 and day 21
measure: Functional Oral Intake Scale
timeFrame: day 1 and day 21
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Saint Martin Hospital
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: STUDY_CHAIR
References: