DysphagiaNCT06256848
Effect of Myofascial Release on Dysphagia in Stroke Survivors
A study testing Rehabilitation treatment and Myofascial Release Therapy in people with Dysphagia, run by Zeng Changhao at 1 site in Philippines.
Trial summary
The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Stroke Survivors. The main question it aims to answer is: Can Myofascial Release Therapy improve swallowing function in Stroke Survivors? Patients will be randomly allocated into the control group or the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Rehabilitation treatment and Myofascial Release Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePhilippines
- Study dates
- 29 Feb 2024to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years;
- meeting the diagnostic criteria of stroke;
- any degree of dysphagia at admission;
- steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
- transferred out within three weeks of hospitalization in the neurology department.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study to Explore Effect of Myofascial Release on Dysphagia in Stroke Survivors
The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Stroke Survivors. The main question it aims to answer is:
- Can Myofascial Release Therapy improve swallowing function in Stroke 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.
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 Stroke Survivors. The main question it aims to answer is:
- Can Myofascial Release Therapy improve swallowing function in Stroke 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.
- Conditions
- Dysphagia
- Being tested
- Rehabilitation treatment, Myofascial Release Therapy
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation treatmentBehavioural
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 TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| rehabilitation treatment+ Myofascial Release group | Experimental | 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. Receives: Behavioral: Rehabilitation treatment; Behavioral: Myofascial Release Therapy |
| rehabilitation treatment group | Active comparator | 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. Receives: Behavioral: Rehabilitation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1 and day 21
Secondary outcomes (3)
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.
Measured: day 1 and day 21
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.
Measured: day 1 and day 21
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.
Measured: day 1 and day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start29 Feb 2024
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Master, Study chair, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256848
- Sponsor's protocol ID
- Jinmo-Stroke
- Status last verified
- Mar 2024
- First submitted
- 3 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Explore Effect of Myofascial Release on Dysphagia in Stroke Survivors
- ClinicalTrials.gov ID
- NCT06256848
- Acronym / sponsor ID
- Jinmo-Stroke
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Stroke Survivors. The main question it aims to answer is:
- Can Myofascial Release Therapy improve swallowing function in Stroke 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 Stroke Survivors. The main question it aims to answer is:
- Can Myofascial Release Therapy improve swallowing function in Stroke 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rehabilitation treatment+ Myofascial Release group | Experimental | Behavioral: Rehabilitation treatment, Behavioral: Myofascial Release TherapyStudy 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. |
| rehabilitation treatment group | Active comparator | Behavioral: Rehabilitation treatmentStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years;
- meeting the diagnostic criteria of stroke;
- any degree of dysphagia at admission;
- steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
- transferred out within three weeks of hospitalization in the neurology department.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation treatmentBoth 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. | Behavioural | rehabilitation treatment group, rehabilitation treatment+ Myofascial Release group |
| Myofascial Release TherapyMyofascial 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. | Behavioural | rehabilitation treatment+ Myofascial Release group |
Primary outcome
Penetration-Aspiration Scale
Time frame: day 1 and day 21
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.
3 secondary outcomes
Swallowing Quality of Life questionnaire
Time frame: day 1 and day 21
Patient health questionnaire-9
Time frame: day 1 and day 21
Functional Oral Intake Scale
Time frame: day 1 and day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieto Luis, Master study chair
Site Coordinator of United Medical Group located in Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation treatment and Myofascial Release Therapy in people with Dysphagia, run by Zeng Changhao at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhefeng Wang, Master (19501376864, zhengzhouzhj@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration-Aspiration Scale (time frame: day 1 and day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.