Effects of Respiratory Exercises in Patients With Hemiplegia

February 3, 2020 updated by: Bezmialem Vakif University

Correlation of Pulmonary Function Test and Ultrasonographic Diaphragm Measurements in Patients With Hemiplegia and Investigation of the Effects of Respiratory Exercises on These Parameters

This study evaluates the effects of respiratory exercises on respiratory function test parameters and ultrasonographic diaphragmatic measurements. Half of the hemiplegic patients will receive respiratory and neurophysiological exercises, while other half will receive only neurophysiological exercises.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After stroke, diaphragm, the most important muscle of respiration, is wasted as well as the other muscles of the affected side.

Ultrasonography is a non-invasive, practical, low cost utility that may measure the thickness of diaphragm in maximum expiration and inspiration thus examining the functionality of the muscle. Correlation between respiratory functional tests and diaphragm ultrasonography has been proven in recent literature. In this manner, the aim of this study is twofold. First is to determine whether ultrasonography can be used practically to evaluate the respiratory functions of the patients after stroke. Respiratory function tests will be used for the correlation analysis. Second is to evaluate the effectiveness of respiratory exercises via diaphragm ultrasonography and respiratory function tests.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Turkey
      • Istanbul, Turkey, 34093
        • Bezmialem Vakıf Univesity

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

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stroke confirmed radiologically
  • Unilateral hemiplegia
  • First stroke episode
  • Mini Mental score ≥ 24

Exclusion Criteria:

  • Unable to consent and understand
  • Chronic cardiac disease
  • Pulmonary disease (asthma, restrictive or obstructive pulmonary disease)
  • Facial paralysis
  • History of thoracic or abdominal surgery
  • Being alcoholic
  • Using psychotropic drugs

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: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Respiratory rehabilitation

Conventional rehabilitation program aiming to normalize movement patterns and minimize spasticity. Including static and dynamic control of position, balance skills, weight shift, and activities of daily living. 45 minutes, once daily.

Respiratory exercises 30 minutes, once daily, (incentive spirometric trainer, forced expiration, percussion, postural drainage etc.)
Procedure: Conventional rehabilitation
Static and dynamic control of position, balance skills, weight shift, and activities of daily living.
Procedure: Respiratory rehabilitation
Forced expiration, forced inspiration (thoracal expansion exercise), coughing exercise, incentive spirometric trainer, diaphragmatic respiration exercise, autogenic drainage, percussion.
PLACEBO_COMPARATOR: Conventional rehabilitation
Conventional rehabilitation program aiming to normalize movement patterns and minimize spasticity. Including static and dynamic control of position, balance skills, weight shift, and activities of daily living. 45 minutes, once daily.
Procedure: Conventional rehabilitation
Static and dynamic control of position, balance skills, weight shift, and activities of daily living.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced vital capacity (FVC)
Time Frame: 6 weeks
The amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Measured by spirometry. >80% is normal. If the value is lower than the normal limit it indicates either an obstructive or restrictive disease. The lower values show a poorer outcome
6 weeks
Forced expiratory volume in one second (FEV1)
Time Frame: 6 weeks
The maximal amount of air you can forcefully exhale in one second. Measured by spirometry. >80% is normal. If there is an obstruction, this measurement shows the severity of the obstruciton. The lower values show a poorer outcome.
6 weeks
Tiffeneau-Pinelli index
Time Frame: 6 weeks
A calculated ratio used in the diagnosis of obstructive and restrictive lung disease. Calculated as FEV1/FVC. >80% is normal. ≤80% indicates an obstructive pulmonary disease.
6 weeks
Forced expiratory flow at 25% and 75% (FEF 25-75%)
Time Frame: 6 weeks
The average forced expiratory flow during the mid (25% - 75%) portion of the FVC. Shows small and medium airway obstruction. >70% is normal. It shows the small airways impariment
6 weeks
Diaphragmatic thickening fraction (TF)
Time Frame: 6 weeks
Thickness of the diaphragm is measured from the zone of apposition (subcostal area between anterior axillary line and mid-axillary line) via ultrasonography. After diaphragm thickness in end expiration (thickness in functional residual capacity- TFRC) and in end inspiration (thickness in total lung capacity- TTLC) are obtained. Thickening fraction is calculated as [TTLC-TFRC/TFRC]x100. A higher value shows a better outcome.
6 weeks

Collaborators and Investigators

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

Sponsor

Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2019

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (ACTUAL)

December 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54022451-050.05.04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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