Effects of Respiratory Exercises in Patients With Hemiplegia

Not Applicable

Completed

• Conditions: Hemiplegia; Respiratory Abnormality
• Interventions: Procedure: Conventional rehabilitation; Procedure: Respiratory rehabilitation

• Registration Number: NCT03763019
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Study Start: 2019-05-01
• Status Verified: 2020-02
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional rehabilitation	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.
Respiratory rehabilitation	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. Respiratory exercises 30 minutes, once daily, (incentive spirometric trainer, forced expiration, percussion, postural drainage etc.)
Respiratory rehabilitation	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.)

Primary Outcome Measures

Name	Time	Method
Tiffeneau-Pinelli index	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.
Diaphragmatic thickening fraction (TF)	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.
Forced expiratory volume in one second (FEV1)	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.
Forced expiratory flow at 25% and 75% (FEF 25-75%)	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
Forced vital capacity (FVC)	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

Trial Locations

Locations (1)

Bezmialem Vakıf Univesity; 🇹🇷 Istanbul, Turkey