Traumatic Brain Injury Clinical Trial
Official title:
Impact of Myofascial Release on Dysphagia in Patients With Traumatic Brain Injury: A Randomized Controlled Study
Verified date | March 2024 |
Source | Chao Phya Abhaibhubejhr Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Copka Sonpashan |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 21 | |
Secondary | 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. | day 1 and day 21 | |
Secondary | 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. | day 1 and day 21 | |
Secondary | 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. | day 1 and day 21 |
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