Stroke PatientsNCT04473872
Effects of Respiratory Physiotherapy on Postural Control, Balance, Respiratory Functions and Respiratory Muscle Strength
A study testing respiratory rehabilitation in people with Stroke Patients, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to determine the effect of respiratory physiotherapy applied on stroke diagnosis, balance, respiratory functions and respiratory muscle strength in addition to neurodevelopmental treatment in patients with stroke. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke Patients
- What is being tested?
- respiratory rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 3 Aug 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 40 years old,
- Stroke diagnosis,
- The Mini-mental test score is above 23
Who cannot join
- Other neurological or orthopedic problems that affect functionality and balance, other than stroke
- High blood pressure, heart disease which may prevent rehabilitation
- Patients with pulmonary disease (COPD)
- Have undergone thoracic or cardiovascular surgery
- Agnosia or a person with visual impairment,
- Patients with epilepsy,
Show all 11Show fewer
- The medical condition is not stable,
- Patients with reluctance towards treatment,
- Patients with communication problem,
- An area under 23 points from the Minimental Test,
- Patients with peripheral nerve injury before stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Respiratory Physiotherapy Applied to Neurodevelopmental Treatment on Postural Control, Balance, Respiratory Functions and Respiratory Muscle Strength in Stroke Patients
The aim of our study is to determine the effect of respiratory physiotherapy applied on stroke diagnosis, balance, respiratory functions and respiratory muscle strength in addition to neurodevelopmental treatment in patients with stroke.
Read the detailed description
Our study will include individuals aged 40-75 years, diagnosed with ischemic or hemorrhagic stroke, who applied to the Kırıkkale University Faculty of Medicine physical therapy and rehabilitation clinic. After the patients are separated according to the specified exclusion and inclusion criteria, they will be divided into 3 groups using the "Online Random Allocation Software" program. Evaluations will be made before and after treatment.
In addition to normal neurodevelopmental therapy (NGT) 5 days a week, respiratory physiotherapy will be applied. The total duration of treatment will take 6 weeks.
- Neurodevelopmental treatment program (BOBATH treatment approach) will be applied to the group.
- The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and diaphragmatic breathing exercises.
- The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and respiratory muscle training with the THRESHOLD IMT device.
Inspiratory Muscle Training Program with Threshold IMT device: Constant pressure is applied to the inspiration phase during application. The training group is started from 40% of MIP and inspiratory muscle training is given. In practice, patients are asked to sit in a loose position on the upper chest and shoulders. After the nose clip is attached, the patient is instructed to tighten his lips around the mouthpiece of the instrument, making inspiration and expiration. After eight breathing cycles, she is asked to do 1-2 respiratory controls.
Diaphragmatic breathing exercise: The patient is given a supine position, a pillow is placed under his knees and head. The patient is asked to place his right hand in the upper abdomen and his left hand in the upper part of his chest. The patient is told to take a slow and deep breath through the nose until four counts, and to hold the air in for the breathing time, and then to the patient, shrinking his lips like a whistle, and exhaling his breath for a long time. Exercises are performed two hours after meals, initially as short as 2-3 minutes, within 10 minutes of the patient's tolerance, with an average of 30 minutes per day.
- Conditions
- Stroke Patients
- Being tested
- respiratory rehabilitation
- Keywords
- respiratory rehabilitation, balance, Postural Control, Respiratory Functions, Respiratory Muscle Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory rehabilitationOther
intervention includes respiratory muscle strengthening with diaphragmatic respiration and IMT device, in addition to neurodevelopmental rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Neurodevelopmental treatment program group | Active comparator | When applying NGT, which is described as a problem solving approach, the treatment program appropriate for their functional levels will be determined for each patient, taking into account the individual needs and wishes of the patient. Principles to be considered while applying the treatment program:
* Inhibition of normal / ineffective movements
* Facility of normal / effective movements Sensory-motor stimulation
* Correct placement of body segments Neurodevelopmental treatment physiotherapy session for 5-days in a week, over 6-week. Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities. Receives: Other: respiratory rehabilitation |
| diaphragmatic breathing | Experimental | The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and diaphragmatic breathing exercises. Diaphragmatic breathing; To give the patient a supine position, a pillow is placed under his knees and head. The patient is asked to place his right hand on the upper abdomen and his left hand on the upper part of his chest. The patient is told to take a slow and deep breath through the nose until four counts, and to hold the air in for the time it has inhaled, and then the patient shrinks her lips like a whistle and exhales from using her breath for a long time. Exercises are performed two hours after meals, in short, 2-3 minutes in the beginning, in 10 of the patients, on average 30 minutes per day. Receives: Other: respiratory rehabilitation |
| respiratory muscle training with the THRESHOLD IMT device | Experimental | The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and respiratory muscle training with the THRESHOLD IMT device. T-IMT is an instrument that provides the same pressure in each breath for the strength and endurance of the inspiratory muscles, regardless of the patient's rapid or slow breathing. This device provides a constant pressure in inspiration with its flow-free one-way valve. It also has an adjustable device pressure. The tool consists of pressure section, mouthpiece and nose clip. During application, constant pressure is applied to the inspiration phase. The training group is started from 40% of MIP and inspiratory muscle training is given. In practice, patients are asked to sit in a loose position on the upper chest and shoulders. After eight breathing cycles, 1-2 respiratory controls are requested Receives: Other: respiratory rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Test
It was used to determine the cognitive state before the training. The Mini-Mental State Test was first published by Folstein et al. It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points. The ideal threshold value of the Mini-Mental State Test was found to be 24.
Measured: 15 minutes
Time Up and Go Test
This test is applied to assess the risk of falling and mobility.This test starts with the individual leaving the chair without receiving arm support by giving the go command while sitting in a chair.The distance of 3 meters is asked to return and sit again in the chair.The elapsed time is recorded in seconds.
Measured: 5 minutes
Berg Balance Scale
It is a 14-item scale that evaluates the tasks used in daily life activities.Standing up without support, standing without support, sitting without support, standing up, transfers, standing with feet, standing with legs while standing, reaching out while standing, picking up from the ground, looking back, 360 degree rotation, firm side standing on the stool, one foot standstill and standstill functions are evaluated.Each item is planned between 0-4; 0 is unable to fulfill the task, 4 is to fulfill the task successfully. The total score of the test is between 0-56.0-20 points: wheelchair dependent, 21-40: assisted walking, 41-56: means independent ambulation.
Measured: 15 minutes
Trunk Impairment Scale
Evaluate the motor loss in trunk after stroke.It is a scale consisting of 17 items.3 items assess the static sitting balance, dynamic balance with 10 items, coordination with 4 items.The score is 0-23.The highest score is considered the best performance.
Measured: 5 minutes
Functional Reach Test
Subjects will asked to stand comfortably, to make a fist, and to raise their arm until it was parallel to the yardstick (position 1). The placement of the end of the third metacarpal along the yardstick will recorded. Subjects will then asked to reach as far forward as they could without losing their balance (position 2), and the position of the end of the third metacarpal along the yardstick will again recorded. No attempt will make to control the subject's method of reach, but if he will touch the wall or took a step during the maneuver, that trial will consider invalid and repeated
Measured: 5 minutes
Respiratory function test
Respiratory function test measurements were made according to the criteria of the spirometer (BTL-08 Spiro Pro system, Germany) ATS. The best of the three consecutive measurements were recorded. After respiratory function tests, Forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF) values were recorded in liters.
Measured: 5 minutes
Inspiratory and expiratory muscle strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values were measured using the electronic mouth pressure measuring device (Pocket-Spiro MPM100 M, Bruxelles). As indicated by Black and Hyatt, MIP was measured in residual volume and MEP total lung capacity. Measurements were made 3 times and the best measurement was recorded
Measured: 5 minutes
Six minute walk test
The functional capacity of individuals was evaluated with 6MWT. The measurements were made in line with the recommendations of the American Thoracic Society. Individuals were asked to walk in the 30-meter corridor for six minutes at their walking speed, but as far as possible. During the test, individuals were allowed to stop and rest. The test was repeated twice daily. Highest 6 minutes walking distance recorded in meters
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Sep 2017
- Primary completion13 Jul 2020
- Study completion3 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stroke PatientsStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Our study will include individuals aged 40-75 years, diagnosed with ischemic or hemorrhagic stroke, who applied to the Kırıkkale University Faculty of Medicine physical therapy and rehabilitation clinic. After the patients are separated according to the specified exclusion and inclusion criteria, they will be divided into 3 groups using the "Online Random Allocation Software" program. In addition to normal neurodevelopmental therapy (NGT) 5 days a week, respiratory physiotherapy will be applied. The total duration of treatment will take 6 weeks. 1. Neurodevelopmental treatment program (BOBATH treatment approach) will be applied to the group. 2. The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and diaphragmatic breathing exercises. 3. The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and respiratory muscle training with the THRESHOLD IMT device.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saniye Aydoğan Arslan, Kırıkkale University
- Investigators
- Saniye Aydoğan Arslan, Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473872
- Sponsor's protocol ID
- RespiratoryPhysiotherapyStroke
- Status last verified
- Mar 2023
- First submitted
- 13 Jul 2020
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryerson S, Byl NN, Brown DA, Wong RA, Hidler JM. Altered trunk position sense and its relation to balance functions in people post-stroke. J Neurol Phys Ther. 2008 Mar;32(1):14-20. doi: 10.1097/NPT.0b013e3181660f0c.
PubMed 18463551Gomes-Neto M, Saquetto MB, Silva CM, Carvalho VO, Ribeiro N, Conceicao CS. Effects of Respiratory Muscle Training on Respiratory Function, Respiratory Muscle Strength, and Exercise Tolerance in Patients Poststroke: A Systematic Review With Meta-Analysis. Arch Phys Med Rehabil. 2016 Nov;97(11):1994-2001. doi: 10.1016/j.apmr.2016.04.018. Epub 2016 May 20.
PubMed 27216224Ramos SM, Silva DMD, Buchaim DV, Buchaim RL, Audi M. Evaluation of Respiratory Muscular Strength Compared to Predicted Values in Patients with Stroke. Int J Environ Res Public Health. 2020 Feb 9;17(3):1091. doi: 10.3390/ijerph17031091.
PubMed 32050421Zhang X, Zheng Y, Dang Y, Wang L, Cheng Y, Zhang X, Mao M, Lu X. Can inspiratory muscle training benefit patients after stroke? A systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2020 Jul;34(7):866-876. doi: 10.1177/0269215520926227. Epub 2020 Jun 3.
PubMed 32493056
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Physiotherapy Applied to Neurodevelopmental Treatment on Postural Control, Balance, Respiratory Functions and Respiratory Muscle Strength in Stroke Patients
- ClinicalTrials.gov ID
- NCT04473872
- Acronym / sponsor ID
- RespiratoryPhysiotherapyStroke
- Conditions
- Stroke Patients
- Keywords
- respiratory rehabilitation, balance, Postural Control, Respiratory Functions, Respiratory Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 16 Jul 2020 (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.
The aim of our study is to determine the effect of respiratory physiotherapy applied on stroke diagnosis, balance, respiratory functions and respiratory muscle strength in addition to neurodevelopmental treatment in patients with stroke.
Detailed description
Our study will include individuals aged 40-75 years, diagnosed with ischemic or hemorrhagic stroke, who applied to the Kırıkkale University Faculty of Medicine physical therapy and rehabilitation clinic. After the patients are separated according to the specified exclusion and inclusion criteria, they will be divided into 3 groups using the "Online Random Allocation Software" program. Evaluations will be made before and after treatment.
In addition to normal neurodevelopmental therapy (NGT) 5 days a week, respiratory physiotherapy will be applied. The total duration of treatment will take 6 weeks.
- Neurodevelopmental treatment program (BOBATH treatment approach) will be applied to the group.
- The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and diaphragmatic breathing exercises.
- The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and respiratory muscle training with the THRESHOLD IMT device.
Inspiratory Muscle Training Program with Threshold IMT device: Constant pressure is applied to the inspiration phase during application. The training group is started from 40% of MIP and inspiratory muscle training is given. In practice, patients are asked to sit in a loose position on the upper chest and shoulders. After the nose clip is attached, the patient is instructed to tighten his lips around the mouthpiece of the instrument, making inspiration and expiration. After eight breathing cycles, she is asked to do 1-2 respiratory controls.
Diaphragmatic breathing exercise: The patient is given a supine position, a pillow is placed under his knees and head. The patient is asked to place his right hand in the upper abdomen and his left hand in the upper part of his chest. The patient is told to take a slow and deep breath through the nose until four counts, and to hold the air in for the breathing time, and then to the patient, shrinking his lips like a whistle, and exhaling his breath for a long time. Exercises are performed two hours after meals, initially as short as 2-3 minutes, within 10 minutes of the patient's tolerance, with an average of 30 minutes per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Our study will include individuals aged 40-75 years, diagnosed with ischemic or hemorrhagic stroke, who applied to the Kırıkkale University Faculty of Medicine physical therapy and rehabilitation clinic. After the patients are separated according to the specified exclusion and inclusion criteria, they will be divided into 3 groups using the "Online Random Allocation Software" program. In addition to normal neurodevelopmental therapy (NGT) 5 days a week, respiratory physiotherapy will be applied. The total duration of treatment will take 6 weeks. 1. Neurodevelopmental treatment program (BOBATH treatment approach) will be applied to the group. 2. The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and diaphragmatic breathing exercises. 3. The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and respiratory muscle training with the THRESHOLD IMT device.
| Arm | Type | Receives |
|---|---|---|
| Neurodevelopmental treatment program group | Active comparator | Other: respiratory rehabilitationWhen applying NGT, which is described as a problem solving approach, the treatment program appropriate for their functional levels will be determined for each patient, taking into account the individual needs and wishes of the patient. Principles to be considered while applying the treatment program: * Inhibition of normal / ineffective movements * Facility of normal / effective movements Sensory-motor stimulation * Correct placement of body segments Neurodevelopmental treatment physiotherapy session for 5-days in a week, over 6-week. Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities. |
| diaphragmatic breathing | Experimental | Other: respiratory rehabilitationThe group will have a neurodevelopmental treatment program (BOBATH treatment approach) and diaphragmatic breathing exercises. Diaphragmatic breathing; To give the patient a supine position, a pillow is placed under his knees and head. The patient is asked to place his right hand on the upper abdomen and his left hand on the upper part of his chest. The patient is told to take a slow and deep breath through the nose until four counts, and to hold the air in for the time it has inhaled, and then the patient shrinks her lips like a whistle and exhales from using her breath for a long time. Exercises are performed two hours after meals, in short, 2-3 minutes in the beginning, in 10 of the patients, on average 30 minutes per day. |
| respiratory muscle training with the THRESHOLD IMT device | Experimental | Other: respiratory rehabilitationThe group will have a neurodevelopmental treatment program (BOBATH treatment approach) and respiratory muscle training with the THRESHOLD IMT device. T-IMT is an instrument that provides the same pressure in each breath for the strength and endurance of the inspiratory muscles, regardless of the patient's rapid or slow breathing. This device provides a constant pressure in inspiration with its flow-free one-way valve. It also has an adjustable device pressure. The tool consists of pressure section, mouthpiece and nose clip. During application, constant pressure is applied to the inspiration phase. The training group is started from 40% of MIP and inspiratory muscle training is given. In practice, patients are asked to sit in a loose position on the upper chest and shoulders. After eight breathing cycles, 1-2 respiratory controls are requested |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being over 40 years old,
- Stroke diagnosis,
- The Mini-mental test score is above 23
Key exclusion criteria (11 listed)
- Other neurological or orthopedic problems that affect functionality and balance, other than stroke
- High blood pressure, heart disease which may prevent rehabilitation
- Patients with pulmonary disease (COPD)
- Have undergone thoracic or cardiovascular surgery
- Agnosia or a person with visual impairment,
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 |
|---|---|---|
| respiratory rehabilitationintervention includes respiratory muscle strengthening with diaphragmatic respiration and IMT device, in addition to neurodevelopmental rehabilitation. | Other | Neurodevelopmental treatment program group, diaphragmatic breathing, respiratory muscle training with the THRESHOLD IMT device |
Primary outcome
Mini-Mental State Test
Time frame: 15 minutes
It was used to determine the cognitive state before the training. The Mini-Mental State Test was first published by Folstein et al. It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points. The ideal threshold value of the Mini-Mental State Test was found to be 24.
Time Up and Go Test
Time frame: 5 minutes
This test is applied to assess the risk of falling and mobility.This test starts with the individual leaving the chair without receiving arm support by giving the go command while sitting in a chair.The distance of 3 meters is asked to return and sit again in the chair.The elapsed time is recorded in seconds.
Berg Balance Scale
Time frame: 15 minutes
It is a 14-item scale that evaluates the tasks used in daily life activities.Standing up without support, standing without support, sitting without support, standing up, transfers, standing with feet, standing with legs while standing, reaching out while standing, picking up from the ground, looking back, 360 degree rotation, firm side standing on the stool, one foot standstill and standstill functions are evaluated.Each item is planned between 0-4; 0 is unable to fulfill the task, 4 is to fulfill the task successfully. The total score of the test is between 0-56.0-20 points: wheelchair dependent, 21-40: assisted walking, 41-56: means independent ambulation.
Trunk Impairment Scale
Time frame: 5 minutes
Evaluate the motor loss in trunk after stroke.It is a scale consisting of 17 items.3 items assess the static sitting balance, dynamic balance with 10 items, coordination with 4 items.The score is 0-23.The highest score is considered the best performance.
Functional Reach Test
Time frame: 5 minutes
Subjects will asked to stand comfortably, to make a fist, and to raise their arm until it was parallel to the yardstick (position 1). The placement of the end of the third metacarpal along the yardstick will recorded. Subjects will then asked to reach as far forward as they could without losing their balance (position 2), and the position of the end of the third metacarpal along the yardstick will again recorded. No attempt will make to control the subject's method of reach, but if he will touch the wall or took a step during the maneuver, that trial will consider invalid and repeated
Respiratory function test
Time frame: 5 minutes
Respiratory function test measurements were made according to the criteria of the spirometer (BTL-08 Spiro Pro system, Germany) ATS. The best of the three consecutive measurements were recorded. After respiratory function tests, Forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF) values were recorded in liters.
Inspiratory and expiratory muscle strength
Time frame: 5 minutes
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values were measured using the electronic mouth pressure measuring device (Pocket-Spiro MPM100 M, Bruxelles). As indicated by Black and Hyatt, MIP was measured in residual volume and MEP total lung capacity. Measurements were made 3 times and the best measurement was recorded
Six minute walk test
Time frame: 10 minutes
The functional capacity of individuals was evaluated with 6MWT. The measurements were made in line with the recommendations of the American Thoracic Society. Individuals were asked to walk in the 30-meter corridor for six minutes at their walking speed, but as far as possible. During the test, individuals were allowed to stop and rest. The test was repeated twice daily. Highest 6 minutes walking distance recorded in meters
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 9 Mar 2023.
- Background: PubMed 18463551Ryerson S, Byl NN, Brown DA, Wong RA, Hidler JM. Altered trunk position sense and its relation to balance functions in people post-stroke. J Neurol Phys Ther. 2008 Mar;32(1):14-20. doi: 10.1097/NPT.0b013e3181660f0c.
- Results publication: PubMed 27216224Gomes-Neto M, Saquetto MB, Silva CM, Carvalho VO, Ribeiro N, Conceicao CS. Effects of Respiratory Muscle Training on Respiratory Function, Respiratory Muscle Strength, and Exercise Tolerance in Patients Poststroke: A Systematic Review With Meta-Analysis. Arch Phys Med Rehabil. 2016 Nov;97(11):1994-2001. doi: 10.1016/j.apmr.2016.04.018. Epub 2016 May 20.
- Results publication: PubMed 32050421Ramos SM, Silva DMD, Buchaim DV, Buchaim RL, Audi M. Evaluation of Respiratory Muscular Strength Compared to Predicted Values in Patients with Stroke. Int J Environ Res Public Health. 2020 Feb 9;17(3):1091. doi: 10.3390/ijerph17031091.
- Results publication: PubMed 32493056Zhang X, Zheng Y, Dang Y, Wang L, Cheng Y, Zhang X, Mao M, Lu X. Can inspiratory muscle training benefit patients after stroke? A systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2020 Jul;34(7):866-876. doi: 10.1177/0269215520926227. Epub 2020 Jun 3.
- 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.
Saniye Aydoğan Arslan principal investigator
Kırıkkale 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 respiratory rehabilitation in people with Stroke Patients, run by Kırıkkale 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 3 inclusion and 11 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 9 Mar 2023. 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?
Mini-Mental State Test (time frame: 15 minutes). The study lists 8 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 NCT04473872, which also lists 4 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 9 Mar 2023.