- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06256874
Effect of Myofascial Release on Dysphagia Prevention for Elderly People in the Community
Effect of Myofascial Release on Dysphagia Prevention for Elderly People in the Community: A Preliminary Self-control Study
Study Overview
Status
Conditions
Intervention / Treatment
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 the impact of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address the effects of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) Myofascial Release Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hongji Zeng, Master
- Phone Number: 17695841016
- Email: 535226944@qq.com
Study Contact Backup
- Name: Weiji Zhao, Master
- Phone Number: 17839973473
- Email: zwjww2009@163.com
Study Locations
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-
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Xinzhu, Taiwan
- Recruiting
- Gaoxiong Rehabilitation Hospital
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Contact:
- Sumei Wang, Doctor
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Xinzhu, Taiwan
- Recruiting
- Hsinchu Rehabilitation Hospital
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Contact:
- Haim Liu, Master
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age over 60 years old.
- No hospitalization within the past six months.
- With clear consciousness and able to cooperate with questionnaires and training.
- The elderly people who voluntarily participate and agree to adhere until the end of the study.
- Dysphagia
Exclusion Criteria:
- Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- Physical disability.
- Difficulty in mobility.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: the observation group
The observation group is the only group of the participants.The elderly individuals will be arranged to undergo a continuous three-week (21 days) duration of Myofascial Release Training, with weekends off and training conducted only on weekdays, two sessions per day, each lasting 15-30 minutes.
Each training session will be conducted approximately one hour prior to meals.
Apart from this,we require participants to only engage in daily activities and avoid strenuous and dangerous behaviors
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Swallowing-Related Quality of Life Questionnaire
Time Frame: day 1 and day 21
|
The Swallowing-Related Quality of Life Questionnaire (SWAL-QOL) is a validated tool used to assess the impact of swallowing difficulties on quality of life.
It is a 44-item questionnaire designed to measure the physical, emotional, and social domains of swallowing-related quality of life.The higher final scores indicate the better life quality.
The total score will be converted into a standard percentage
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day 1 and day 21
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time consumed in eating
Time Frame: day 1 and day 21
|
We require participants to eat a lunch according to their daily intake and habits, and count the time consumed
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day 1 and day 21
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Water Swallow Test
Time Frame: day 1 and day 21
|
The Water Swallow Test was recruited to assess swallowing function in patients at admission. Specifically, patients were instructed to sit and drink 30 ml of warm water. A 5-point scoring system is used as follows:
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day 1 and day 21
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Functional Oral Intake Scale
Time Frame: day 1 and day 21
|
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.
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day 1 and day 21
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nieto Luis, Master, Site Coordinator of United Medical Group located in Miami
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Jinmo-old
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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