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NCT Number: NCT04503499

Effect of Thoracic Manual Therapy 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Okan University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manuel therapy

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Oxygen Saturation

    Time frame: 4 weeks

    Pulse oximetry device will measure oxygen saturation. Values before and after treatment will be measured and recorded.

  10. Heart Rate

    Time frame: 4 weeks

    Pulse oximetry device will measure heart rate. Values before and after treatment will be measured and recorded.

  11. Respiratory Frequency

    Time frame: 4 weeks

    Pulse oximetry device will measure respiratory frequency. Values before and after treatment will be measured and recorded.

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

Acute Effect of Thoracic Manual Therapy on Respiratory Capacity in Hemiplegic Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2020
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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