- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04503499
Effect of Thoracic Manual Therapy in Hemiplegic Patients
Acute Effect of Thoracic Manual Therapy on Respiratory Capacity in Hemiplegic Patients
Neurological problems both lead to many respiratory problems primarily and events secondary to neurological diseases or symptoms can be the cause of respiratory failure. The addition of respiratory failure will adversely affect the course of the neurological picture, making treatment more difficult.
The cardiopulmonary functions of hemiplegia patients decrease due to the decrease in the expansion of the thoracic part on the hemiplegic side and insufficient respiratory muscles. In addition, common symptoms in stroke patients, including limited use of ankylosis and muscle movements, cause oxygen deficiency and increased metabolic demands. After stroke, thoracic expansion is reduced upon paralysis of the diaphragm and respiratory muscles. Continuation of this condition can lead to muscle fibrosis. As a result, the level of thoracic expansion decreases during breathing.
A decrease in thoracic spine mobility correlates with a decrease in forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1). The increase in the rigidity of the chest wall affects the ventilator pumping mechanism, reducing the level of rigidity (increasing the mobility of the chest wall) is recommended as a way to improve lung function.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey
- Istanbul Okan University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 45-65 years old
- Stage 4-6 according to Brunnstrom
- According to Modified Ashworth, the upper extremity is at most two values
- Sufficient to answer the level of consciousness survey
- No smoking
- No hearing or vision loss
Exclusion Criteria:
- Not being able to read and write
- Having cognitive impairment
- Hearing difficulties and vision loss
- Having any acute pain
- Acute Bronchitis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
The group to which the manuel therapy will be applied.
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The manual therapy protocol will consist of 45-60 minutes and the following techniques;
Myofascial release techniques will be applied for 3-5 minutes each. Mobilization techniques were applied in each joint for 30 seconds and 5 times. |
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No Intervention: Control Group
The control group where only the evaluations will be made.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chest circumference measurement
Time Frame: 4 weeks
|
Chest circumference measurement will be measured from the axillary (3rd costa), epigastric (xiphoid) and subcostal (mid xiphoid-umbilicus) areas, and measuring will be done by tape measure in inspiration and expiration.
|
4 weeks
|
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Forced expiratory volume
Time Frame: 4 weeks
|
Forced expiratory volume will be performed in a sitting position using a portable spirometer (Spirobank; Medical International Research, Rome, Italy) according to the American Thoracic Society rules.
Participants will rest before the test to prevent fatigue.
While the patient is sitting in a comfortable position on the chair, his nose will be closed with a clip and the mouthpiece will be placed and the measurement will be made.
The patient will be asked to perform deep and long-term expiration after deep and severe inspiration after performing calm breathing three times.
The measurement will be repeated three times.
|
4 weeks
|
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Forced vital capacity
Time Frame: 4 weeks
|
Forced vital capacity will be performed in a sitting position using a portable spirometer (Spirobank; Medical International Research, Rome, Italy) according to the American Thoracic Society rules.
Participants will rest before the test to prevent fatigue.
While the patient is sitting in a comfortable position on the chair, his nose will be closed with a clip and the mouthpiece will be placed and the measurement will be made.
The patient will be asked to perform deep and long-term expiration after deep and severe inspiration after performing calm breathing three times.
The measurement will be repeated three times.
|
4 weeks
|
|
Forced expiratory volume / Forced vital capacity
Time Frame: 4 weeks
|
Forced expiratory volume / Forced vital capacity test will be performed in a sitting position using a portable spirometer (Spirobank; Medical International Research, Rome, Italy) according to the American Thoracic Society rules.
Participants will rest before the test to prevent fatigue.
While the patient is sitting in a comfortable position on the chair, his nose will be closed with a clip and the mouthpiece will be placed and the measurement will be made.
The patient will be asked to perform deep and long-term expiration after deep and severe inspiration after performing calm breathing three times.
The measurement will be repeated three times.
|
4 weeks
|
|
Peak Expiratory Flow
Time Frame: 4 weeks
|
Peak Expiratory Flow test will be performed in a sitting position using a portable spirometer (Spirobank; Medical International Research, Rome, Italy) according to the American Thoracic Society rules.
Participants will rest before the test to prevent fatigue.
While the patient is sitting in a comfortable position on the chair, his nose will be closed with a clip and the mouthpiece will be placed and the measurement will be made.
The patient will be asked to perform deep and long-term expiration after deep and severe inspiration after performing calm breathing three times.
The measurement will be repeated three times.
|
4 weeks
|
|
Maximal Expiratory Pressure
Time Frame: 4 weeks
|
Maximal expiratory pressure will be assessed using an electronic pressure transducer (MicroRPM; Micro Medical Ltd., Kent, UK).
It will be measured according to maximal expiratory pressure Black and Hyatt.
In Maximal Expiratory Pressure measurement from the patient; After doing maximal inspiration in a comfortable sitting position, his nose will be closed with a clip and he will be asked to make maximum expiration from the mouthpiece.
The measurements will be repeated three times and the highest values will be recorded.
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4 weeks
|
|
Maximal Inspiratory Pressure
Time Frame: 4 weeks
|
Maximal inspiratory pressure will be assessed using an electronic pressure transducer (MicroRPM; Micro Medical Ltd., Kent, UK).
It will be measured according to Maximal Inspiratory Pressure Black and Hyatt.
From the patient in Maximal Inspiratory Pressure measurement; the patient is in a comfortable sitting position, after making maximum expiration, his nose will be closed with the help of a clip and he will be asked to make maximum inspiration from the mouthpiece.
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4 weeks
|
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Respiratory Muscle Endurance
Time Frame: 4 weeks
|
Respiratory muscle endurance measurement will be performed with the Power Breath (HaB International Ltd.
Southam, UK) portable device.
Power Breath resistance will be adjusted by taking 60% of the maximal inspiratory pressure.
The test time will be calculated and recorded in seconds.
Power Breath resistance is adjusted in a comfortable sitting position, the clip will be recorded while the clip is attached to the nose and the mouthpiece of the device is inhaled.
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4 weeks
|
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Oxygen Saturation
Time Frame: 4 weeks
|
Pulse oximetry device will measure oxygen saturation.
Values before and after treatment will be measured and recorded.
|
4 weeks
|
|
Heart Rate
Time Frame: 4 weeks
|
Pulse oximetry device will measure heart rate.
Values before and after treatment will be measured and recorded.
|
4 weeks
|
|
Respiratory Frequency
Time Frame: 4 weeks
|
Pulse oximetry device will measure respiratory frequency.
Values before and after treatment will be measured and recorded.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0002
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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