Effects of Respiratory Exercises in Patients With Hemiplegia

NCT ID: NCT03763019

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemiplegia Respiratory Abnormality

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.)

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type PROCEDURE

Static and dynamic control of position, balance skills, weight shift, and activities of daily living.

Respiratory rehabilitation

Intervention Type PROCEDURE

Forced expiration, forced inspiration (thoracal expansion exercise), coughing exercise, incentive spirometric trainer, diaphragmatic respiration exercise, autogenic drainage, percussion.

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.

Group Type PLACEBO_COMPARATOR

Conventional rehabilitation

Intervention Type PROCEDURE

Static and dynamic control of position, balance skills, weight shift, and activities of daily living.

Interventions

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Conventional rehabilitation

Static and dynamic control of position, balance skills, weight shift, and activities of daily living.

Intervention Type PROCEDURE

Respiratory rehabilitation

Forced expiration, forced inspiration (thoracal expansion exercise), coughing exercise, incentive spirometric trainer, diaphragmatic respiration exercise, autogenic drainage, percussion.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ozan Volkan Yurdakul, MD

Role: STUDY_DIRECTOR

Bezmialem University

Locations

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Bezmialem Vakıf Univesity

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Jung KJ, Park JY, Hwang DW, Kim JH, Kim JH. Ultrasonographic diaphragmatic motion analysis and its correlation with pulmonary function in hemiplegic stroke patients. Ann Rehabil Med. 2014 Feb;38(1):29-37. doi: 10.5535/arm.2014.38.1.29. Epub 2014 Feb 25.

Reference Type BACKGROUND
PMID: 24639923 (View on PubMed)

Kim M, Lee K, Cho J, Lee W. Diaphragm Thickness and Inspiratory Muscle Functions in Chronic Stroke Patients. Med Sci Monit. 2017 Mar 11;23:1247-1253. doi: 10.12659/msm.900529.

Reference Type BACKGROUND
PMID: 28284044 (View on PubMed)

Cardenas LZ, Santana PV, Caruso P, Ribeiro de Carvalho CR, Pereira de Albuquerque AL. Diaphragmatic Ultrasound Correlates with Inspiratory Muscle Strength and Pulmonary Function in Healthy Subjects. Ultrasound Med Biol. 2018 Apr;44(4):786-793. doi: 10.1016/j.ultrasmedbio.2017.11.020. Epub 2018 Jan 17.

Reference Type BACKGROUND
PMID: 29373153 (View on PubMed)

Other Identifiers

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54022451-050.05.04

Identifier Type: -

Identifier Source: org_study_id

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