Hemiplegia,Stroke, Respiratory, Neurophysiological Facilitation TechniquesNCT05601934
The Effect of Neurophysiological Facilitation Techniques on Respiratory in Stroke
A study testing Neurophysiological Facilitation Techniques in people with Hemiplegia,Stroke, Respiratory, Neurophysiological Facilitation Techniques, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hemiplegia,Stroke, Respiratory, Neurophysiological Facilitation Techniques
- What is being tested?
- Neurophysiological Facilitation Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2020to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 40 years
- Stroke Patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Neurophysiological Facilitation Techniques
- Keywords
- Stroke, Respiratory, Physiotherapy and Rehabilitation, Neurophysiological Facilitation Techniques, Exercise
- Medical subject headings
- Hemiplegia, Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurophysiological Facilitation TechniquesOther
Also called Respiratory exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurophysiological Facilitation Techniques | Experimental | Not described Receives: Other: Neurophysiological Facilitation Techniques |
| Respiratory exercises | Experimental | Not described Receives: Other: Neurophysiological Facilitation Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory and/or expiratory muscle strength
Neurophysiological facilitation techniques increases inspiratory muscle strength and causes decrease in dyspnea especially in the acute period.
Measured: 6 months
Positive Effect of Neurophysiological Facilitation Techniques on Pulmonary Stroke Patients
Neurophysiological facilitation techniques that have positive effects in patients practice by physiotherapists should be encouraged.
Measured: 6 months
Secondary outcomes (1)
Complications
There was no complications in this study so this method can be used in practice
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start21 Jun 2020
- Primary completion21 Jun 2021
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia,Stroke, Respiratory, Neurophysiological Facilitation TechniquesStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Collaborators
- Gül Deniz YILMAZ YELVAR, Yasemin Çırak, Serap İNAL, Nurgül DÜRÜSTKAN ELBAŞI
- Responsible party
- Principal investigator, Ali Enes Yaşar, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601934
- Sponsor's protocol ID
- Ali Enes YAŞAR
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neurophysiological Facilitation Techniques on Respiratory in Stroke
- ClinicalTrials.gov ID
- NCT05601934
- Acronym / sponsor ID
- Ali Enes YAŞAR
- Keywords
- Stroke, Respiratory, Physiotherapy and Rehabilitation, Neurophysiological Facilitation Techniques, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Collaborators
- Gül Deniz YILMAZ YELVAR, Yasemin Çırak, Serap İNAL, Nurgül DÜRÜSTKAN ELBAŞI
- Study start
- 21 Jun 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurophysiological Facilitation Techniques | Experimental | Other: Neurophysiological Facilitation Techniques |
| Respiratory exercises | Experimental | Other: Neurophysiological Facilitation Techniques |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Above 40 years
- Stroke Patients
Key exclusion criteria (6 listed)
- Active Smokers
- Thoracal Scoliosis Patients
- Chest Deformity Patients
- Traumatic Injuries in the Chest
- Pneumonia,COPD(Chronic obstructive pulmonary disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurophysiological Facilitation TechniquesAlso: Respiratory exercisesIncreased 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 | Neurophysiological Facilitation Techniques, Respiratory exercises |
Primary outcome
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.
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.
1 secondary outcome
Complications
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurophysiological Facilitation Techniques in people with Hemiplegia,Stroke, Respiratory, Neurophysiological Facilitation Techniques, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory and/or expiratory muscle strength (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.