<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04503499</url>
  </required_header>
  <id_info>
    <org_study_id>0002</org_study_id>
    <nct_id>NCT04503499</nct_id>
  </id_info>
  <brief_title>Effect of Thoracic Manual Therapy in Hemiplegic Patients</brief_title>
  <official_title>Acute Effect of Thoracic Manual Therapy on Respiratory Capacity in Hemiplegic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istinye University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istinye University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neurological problems both lead to many respiratory problems primarily and events secondary&#xD;
      to neurological diseases or symptoms can be the cause of respiratory failure. The addition of&#xD;
      respiratory failure will adversely affect the course of the neurological picture, making&#xD;
      treatment more difficult.&#xD;
&#xD;
      The cardiopulmonary functions of hemiplegia patients decrease due to the decrease in the&#xD;
      expansion of the thoracic part on the hemiplegic side and insufficient respiratory muscles.&#xD;
      In addition, common symptoms in stroke patients, including limited use of ankylosis and&#xD;
      muscle movements, cause oxygen deficiency and increased metabolic demands. After stroke,&#xD;
      thoracic expansion is reduced upon paralysis of the diaphragm and respiratory muscles.&#xD;
      Continuation of this condition can lead to muscle fibrosis. As a result, the level of&#xD;
      thoracic expansion decreases during breathing.&#xD;
&#xD;
      A decrease in thoracic spine mobility correlates with a decrease in forced vital capacity&#xD;
      (FVC) and forced expiratory volume in the first second (FEV1). The increase in the rigidity&#xD;
      of the chest wall affects the ventilator pumping mechanism, reducing the level of rigidity&#xD;
      (increasing the mobility of the chest wall) is recommended as a way to improve lung function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2018</start_date>
  <completion_date type="Actual">August 15, 2019</completion_date>
  <primary_completion_date type="Actual">July 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chest circumference measurement</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced expiratory volume</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced vital capacity</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced expiratory volume / Forced vital capacity</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak Expiratory Flow</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal Expiratory Pressure</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal Inspiratory Pressure</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Muscle Endurance</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygen Saturation</measure>
    <time_frame>4 weeks</time_frame>
    <description>Pulse oximetry device will measure oxygen saturation. Values before and after treatment will be measured and recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>Pulse oximetry device will measure heart rate. Values before and after treatment will be measured and recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Frequency</measure>
    <time_frame>4 weeks</time_frame>
    <description>Pulse oximetry device will measure respiratory frequency. Values before and after treatment will be measured and recorded.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group to which the manuel therapy will be applied.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group where only the evaluations will be made.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manuel Therapy</intervention_name>
    <description>The manual therapy protocol will consist of 45-60 minutes and the following techniques;&#xD;
suboccipital decompression&#xD;
cervical mobilization (in the posterior-anterior direction)&#xD;
sternocleidomastoid release&#xD;
scalene release&#xD;
trapezoidal release&#xD;
scalene release&#xD;
pectoralis tractus&#xD;
sternoclavicular joint mobilization&#xD;
sternum mobilization&#xD;
parasternal circumference intercostal and paravertebral release&#xD;
diaphragm release&#xD;
rib reasing&#xD;
scapulothoracic joint mobilization&#xD;
thoracic vertebra mobilization&#xD;
Myofascial release techniques will be applied for 3-5 minutes each.&#xD;
Mobilization techniques were applied in each joint for 30 seconds and 5 times.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being between 45-65 years old&#xD;
&#xD;
          -  Stage 4-6 according to Brunnstrom&#xD;
&#xD;
          -  According to Modified Ashworth, the upper extremity is at most two values&#xD;
&#xD;
          -  Sufficient to answer the level of consciousness survey&#xD;
&#xD;
          -  No smoking&#xD;
&#xD;
          -  No hearing or vision loss&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not being able to read and write&#xD;
&#xD;
          -  Having cognitive impairment&#xD;
&#xD;
          -  Hearing difficulties and vision loss&#xD;
&#xD;
          -  Having any acute pain&#xD;
&#xD;
          -  Acute Bronchitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Okan University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istinye University</investigator_affiliation>
    <investigator_full_name>Yasemin Çırak</investigator_full_name>
    <investigator_title>Physiotherapist, PhD, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>pulmonary function</keyword>
  <keyword>manual therapy</keyword>
  <keyword>respiratory function test</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04503499
org study id: 0002
nct id: NCT04503499
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Chest circumference measurement
time frame: 4 weeks
description: 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.
measure: Forced expiratory volume
time frame: 4 weeks
description: 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.
measure: Forced vital capacity
time frame: 4 weeks
description: 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.
measure: Forced expiratory volume / Forced vital capacity
time frame: 4 weeks
description: 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.
measure: Peak Expiratory Flow
time frame: 4 weeks
description: 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.
measure: Maximal Expiratory Pressure
time frame: 4 weeks
description: 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.
measure: Maximal Inspiratory Pressure
time frame: 4 weeks
description: 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.
measure: Respiratory Muscle Endurance
time frame: 4 weeks
description: 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.
measure: Oxygen Saturation
time frame: 4 weeks
description: Pulse oximetry device will measure oxygen saturation. Values before and after treatment will be measured and recorded.
measure: Heart Rate
time frame: 4 weeks
description: Pulse oximetry device will measure heart rate. Values before and after treatment will be measured and recorded.
measure: Respiratory Frequency
time frame: 4 weeks
description: Pulse oximetry device will measure respiratory frequency. Values before and after treatment will be measured and recorded.
arm group label: Study Group
arm group type: Experimental
description: The group to which the manuel therapy will be applied.
arm group label: Control Group
arm group type: No Intervention
description: The control group where only the evaluations will be made.
intervention type: Other
intervention name: Manuel Therapy
description: The manual therapy protocol will consist of 45-60 minutes and the following techniques;
suboccipital decompression
cervical mobilization (in the posterior-anterior direction)
sternocleidomastoid release
scalene release
trapezoidal release
scalene release
pectoralis tractus
sternoclavicular joint mobilization
sternum mobilization
parasternal circumference intercostal and paravertebral release
diaphragm release
rib reasing
scapulothoracic joint mobilization
thoracic vertebra mobilization
Myofascial release techniques will be applied for 3-5 minutes each.
Mobilization techniques were applied in each joint for 30 seconds and 5 times.
arm group label: Study Group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istinye University
investigator full name: Yasemin Çırak
investigator title: Physiotherapist, PhD, Associate Professor