Effect of Thoracic Manual Therapy in Hemiplegic Patients

November 2, 2023 updated by: Yasemin Çırak, Istinye University

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Istanbul Okan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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.

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
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
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.
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.
4 weeks
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.
4 weeks
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2018

Primary Completion (Actual)

July 15, 2019

Study Completion (Actual)

August 15, 2019

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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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