HemiplegiaNCT03763019
Effects of Respiratory Exercises in Patients With Hemiplegia
A study testing Conventional rehabilitation and Respiratory rehabilitation in people with Hemiplegia and Respiratory Abnormality, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemiplegia, Respiratory Abnormality
- What is being tested?
- Conventional rehabilitation and Respiratory rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Feb 2020
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke confirmed radiologically
- Unilateral hemiplegia
- First stroke episode
- Mini Mental score ≥ 24
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemiplegia, Respiratory Abnormality
- Being tested
- Conventional rehabilitation, Respiratory rehabilitation
- Keywords
- hemiplegia, respiratory function tests, respiratory exercises, diaphragm ultrasonography
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional rehabilitationProcedure or surgery
Static and dynamic control of position, balance skills, weight shift, and activities of daily living.
Respiratory rehabilitationProcedure or surgery
Forced expiration, forced inspiration (thoracal expansion exercise), coughing exercise, incentive spirometric trainer, diaphragmatic respiration exercise, autogenic drainage, percussion.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory rehabilitation | Active comparator | 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.) Receives: Procedure: Conventional rehabilitation; Procedure: Respiratory rehabilitation |
| Conventional rehabilitation | Placebo comparator | 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. Receives: Procedure: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity (FVC)
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
Measured: 6 weeks
Forced expiratory volume in one second (FEV1)
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.
Measured: 6 weeks
Tiffeneau-Pinelli index
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.
Measured: 6 weeks
Forced expiratory flow at 25% and 75% (FEF 25-75%)
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
Measured: 6 weeks
Diaphragmatic thickening fraction (TF)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 May 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ozan Volkan Yurdakul, MD, Study director, Bezmialem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763019
- Sponsor's protocol ID
- 54022451-050.05.04
- Status last verified
- Feb 2020
- First submitted
- 30 Nov 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24639923Kim 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.
PubMed 28284044Cardenas 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.
PubMed 29373153
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Pulmonary Function Test and Ultrasonographic Diaphragm Measurements in Patients With Hemiplegia and Investigation of the Effects of Respiratory Exercises on These Parameters
- ClinicalTrials.gov ID
- NCT03763019
- Acronym / sponsor ID
- 54022451-050.05.04
- Conditions
- Hemiplegia, Respiratory Abnormality
- Keywords
- hemiplegia, respiratory function tests, respiratory exercises, diaphragm ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 4 Dec 2018 (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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory rehabilitation | Active comparator | Procedure: Conventional rehabilitation, Procedure: Respiratory rehabilitationConventional 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.) |
| Conventional rehabilitation | Placebo comparator | Procedure: Conventional rehabilitationConventional 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stroke confirmed radiologically
- Unilateral hemiplegia
- First stroke episode
- Mini Mental score ≥ 24
Key exclusion criteria (7 listed)
- Unable to consent and understand
- Chronic cardiac disease
- Pulmonary disease (asthma, restrictive or obstructive pulmonary disease)
- Facial paralysis
- History of thoracic or abdominal surgery
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 |
|---|---|---|
| Conventional rehabilitationStatic and dynamic control of position, balance skills, weight shift, and activities of daily living. | Procedure or surgery | Conventional rehabilitation, Respiratory rehabilitation |
| Respiratory rehabilitationForced expiration, forced inspiration (thoracal expansion exercise), coughing exercise, incentive spirometric trainer, diaphragmatic respiration exercise, autogenic drainage, percussion. | Procedure or surgery | Respiratory rehabilitation |
Primary outcome
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
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.
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.
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
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.
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 5 Feb 2020.
- Background: PubMed 24639923Jung 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.
- Background: PubMed 28284044Kim 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.
- Background: PubMed 29373153Cardenas 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.
- Individual participant dataSharing planned: No
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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.
Ozan Volkan Yurdakul, MD study director
Bezmialem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional rehabilitation and Respiratory rehabilitation in people with Hemiplegia and Respiratory Abnormality, run by Bezmialem Vakif 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 4 inclusion and 7 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 5 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
Forced vital capacity (FVC) (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03763019, which also lists 3 linked publications.
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 5 Feb 2020.