The Effect of Neurophysiological Facilitation Techniques on Respiratory in Stroke

October 28, 2022 updated by: Ali Enes Yaşar, Istinye University

Hemiplegia is a disease with many complications in its clinical course. One of these complications is respiratory dysfunction. It is aimed to determine the respiratory function problems of patients with hemiplegia and to eliminate the problems by using neurophysiological facilitation techniques.

Restrictive and obstructive pulmonary dysfunction occurs in hemiplegic patients. Decreased movement in the thorax, decreased respiratory muscle strength, changes in muscle tone, and changes in the central nervous system cause restrictive respiratory disorders. A significant decrease is observed in FEV1(Forced Expiratory Volume in One Second), FEV1%, FVC(Forced Vital Capacity), FVC% values.

Alveolar ventilation is maintained through the central nervous system. For alveolar ventilation, the brain must transmit the impulse of breathing to the muscles through the spinal cord and peripheral nervous system. Lesions occurring in any part of the central nervous system affect respiratory functions.

Hemiplegia is a condition that affects the movement of the diaphragm. During quiet breathing, there is a significant decrease in the movement of the diaphragm. Chest expansion is reduced.

In a study, it was reported that neuromuscular facilitation techniques increase short-term ventilation and are reliable techniques for people with neurological damage.

When we look at the literature, there is no study showing the effects of neurophysiological facilitation techniques on respiration in hemiplegic patients. The aim of our study; To determine the effects and safety of neurophysiological facilitation techniques in terms of pulmonary function, respiratory muscle strength, functional capacity and quality of life in hemiplegic patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of our study is to investigate the effect of neurophysiological facilitation techniques on respiratory and functional capacity in stroke individuals. The study included 68 stroke individuals hospitalized in hospital. Participants were divided into two groups as the study group (n=34) in which conventional physiotherapy and neurophysiological facilitation techniques were applied, and the control group (n=34) in which conventional physiotherapy program were applied. Demographic information of the patients was obtained, in terms of respiratory frequency, muscle strength, respiratory muscle strength, functional capacity, functional independence level, fatigue, dyspnea, comorbidity, fear of movement, mental status, pain posture, stroke impact and motor levels before and after treatment. evaluated. The neurophysiological facilitation techniques were applied 5 sessions (5-7 days) in stroke individuals. The evaluations were statistically analyzed using the SPSS(Statistical Package for the Social Sciences)-24 program. When the inspiratory muscle strengths were examined, improvement was observed in both the study and control groups, but it was noted that the muscle strength values of the study group increased significantly compared to the control group and the pre-study period (p<0.05). When expiratory muscle strength was compared before and after treatment, improvement was observed in both groups, but there was no statistically significant difference (p>0.05). When the functional capacity was examined, it was found that statistically significant difference was found in favor of study group (p<0.05). In addition, when the respiratory frequency and dyspnea values of the study group were examined before and after the treatment, a statistically significant difference was found in these two values when compared to the control group (p<0.05). No significant difference was observed in the other evaluations of the participants in both groups (p>0.05). In conclusion, it was showed acute effect of neurophysiological facilitation techniques and it is reliable method to increase respiratory muscle strength, improve functional capacity, and decrease respiratory frequency and dyspnea levels in stroke individuals. It can be used as an alternative approach in the treatment programs to be applied to individuals with stroke and in pulmonary rehabilitation applications.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Üsküdar
      • Istanbul, Üsküdar, Turkey, 34674
        • Home

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Above 40 years
  • Stroke Patients

Exclusion Criteria:

  • Active Smokers
  • Thoracal Scoliosis Patients
  • Chest Deformity Patients
  • Traumatic Injuries in the Chest
  • Pneumonia,COPD(Chronic obstructive pulmonary disease)
  • Mini-Mental State Under 15 Points

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Neurophysiological Facilitation Techniques
Other: Neurophysiological Facilitation Techniques
Increased enlargement of the ribs during inspiration and increased movement in the epigastric region and tone of the abdominal muscles also decreased respiratory rate are some of the changes that occur after these stimuli. In addition to these, involuntary increase in cough, sputum production also decrease in pathological sounds felt on auscultation, decrease in aspiration requirement, rapid return in chest wall stabilization and improvement in respiratory pattern can be observed after application with this application, positive and long-term effective results can be seen in a short time.
Other Names:
  • Respiratory exercises
EXPERIMENTAL: Respiratory exercises
Other: Neurophysiological Facilitation Techniques
Increased enlargement of the ribs during inspiration and increased movement in the epigastric region and tone of the abdominal muscles also decreased respiratory rate are some of the changes that occur after these stimuli. In addition to these, involuntary increase in cough, sputum production also decrease in pathological sounds felt on auscultation, decrease in aspiration requirement, rapid return in chest wall stabilization and improvement in respiratory pattern can be observed after application with this application, positive and long-term effective results can be seen in a short time.
Other Names:
  • Respiratory exercises

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Inspiratory and/or expiratory muscle strength
Time Frame: 6 months
Neurophysiological facilitation techniques increases inspiratory muscle strength and causes decrease in dyspnea especially in the acute period.
6 months
Positive Effect of Neurophysiological Facilitation Techniques on Pulmonary Stroke Patients
Time Frame: 6 months
Neurophysiological facilitation techniques that have positive effects in patients practice by physiotherapists should be encouraged.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 6 months
There was no complications in this study so this method can be used in practice
6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istinye University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yasemin Çırak
Gül Deniz YILMAZ YELVAR
Serap İNAL
Nurgül DÜRÜSTKAN ELBAŞI

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ali Enes YAŞAR

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings