Stroke, CardiovascularNCT04777955
The Effects of Core Stabilization Exercises With Swisball in Stroke Patients
A study testing core stabilization exercises in people with Stroke, Cardiovascular, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Stroke is often associated with secondary complications such as nutritional and metabolic disorders, endocrine dysfunction, mental problems, and cardiopulmonary disorders caused by neurological and musculoskeletal deficits. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Cardiovascular
- What is being tested?
- core stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2021to 1 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral and first time stroke
- Ability to understand and follow verbal instructions
- Brunnstrom healing phase being above 3 for lower limbs;
- Ability to walk 10 m distance independently, with or without a mobility assistant.
- Patients who can sit on a stable surface for 30 seconds
- Patients without respiratory diseases or injuries
Who cannot join
- Neurological disorders other than stroke that could potentially affect balance and ambulation;
- Body failure scale score below 10 points
- Apraxia and hemineglect
- 80 years and older
- Orthopedic disorders or rib fracture
- Patients with neglect syndrome
- A history of seizures or a family history of epilepsy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa
Istanbul, 34147
About this study
Official title: The Effects of Core Stabilization Exercises With Swissball, Neuromuscular Electrical Stimulation and Kinesiology Taping in Stroke Patients
Stroke is often associated with secondary complications such as nutritional and metabolic disorders, endocrine dysfunction, mental problems, and cardiopulmonary disorders caused by neurological and musculoskeletal deficits. The absence of the paretic side muscles and the difficulty of movement together with restrictive pulmonary disorders trigger a secondary decrease in cardiopulmonary function and expose insufficient energy associated with gait resulting in a decrease in asymmetric trunk exercise endurance.
Read the detailed description
Studies have shown that these patients have muscle weakness and delayed activity of trunk muscles, significant loss of trunk position sense, insufficient pressure control center while sitting, decreased trunk performance, and trunk asymmetry during walking. It has been reported that trunk function with balance and walking ability in stroke patients is a useful determinant of daily life activities, balance and walking ability. Balance disorders may be the result of changes in the sensory and integrative aspects of motor control. In the subacute phase, more than 80% of the subjects who have had stroke for the first time have an imbalance in their balance. After a stroke, upper motor neuron damage can cause unconditioned. This results in physical inactivity and decreased cardiorespiratory fitness. Respiratory muscle weakness and changes in thoraco-abdominal motion may be associated with a decrease in tidal volume and lower exercise tolerance.
- Conditions
- Stroke, Cardiovascular
- Being tested
- core stabilization exercises
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stabilization exercisesOther
Also called electrical stimulation, kinesiological banding
Core is at the center of almost all kinetic chains in the body. Core force, balance, and motion control maximize all kinetic chains of upper and lower limb function. A stable and strong core can contribute to more efficient use of the lower extremities. Core stability is defined as the ability of the lumbo-pelvic hip complex to prevent bending of the vertebral column and return to balance after perturbation.
Neuromuscular electrical stimulation (NMES) is a technique in which muscle contraction is electrically stimulated in the area where the surface electrodes are connected. It improves secondary muscle atrophy and weakness in immobilization by preventing a decrease in muscle protein synthesis.
Kinesiological banding (CT) is a treatment method used in the treatment of various musculoskeletal and neuromuscular deficits. The mechanism of action of CT is to facilitate muscle activation, increase blood and lymph circulation and reduce pain due to neurological suppression.
| Study group | Role | What they receive |
|---|---|---|
| Group 1, core stabilization exercises group | Experimental | core stabilization exercises will be performed using swissball. Program: Sitting on the ball will include (weight shifts, forward, backward and lateral sides), (pelvic bridge), (curl-up), (curlsup with diagonal reaching), (bird-dog exercise), (push-up) exercises. The application will be carried out for 6 weeks, 3 days a week for 30-45 minutes daily. Receives: Other: core stabilization exercises |
| Group 2, electrical stimulation | Experimental | An adaptation of a pre-designed protocol will be used for the application of the Normocular Electrical Stimulation in the diaphragm. Current to be applied; Synchronous impulse at 30 Hz frequency, 1 sec beat increase time, 1 sec "on" (muscle contraction), 1 sec beat reduction time and 20 sec "off" (no warning) time. Two channels, each with two electrodes, will be placed in the seventh and eighth anterior intercostal space above and below the right and left sides of the xiphoid protrusion. The other two channels, each with two electrodes, will be placed on the right and left midaxillary line of the seventh and eighth anterior intercostal space. The application will be carried out for 6 weeks, 3 days a week, for 30 minutes daily. Receives: Other: core stabilization exercises |
| group 3, kinesiotape | Experimental | For anterior diaphragm banding, the patient will stand with arms raised. Next, the central part of the tape will be applied to the xiphoid protrusion with a tension of 50% to 70% after the maximum inhalation. While the patient is breathing, the ends of the tape will be pulled with 10 to 15% tension towards the lower ribs. To tape the rear diaphragm, the patient's body will bend forward, and the arms will be joined crosswise over the chest. After the maximum inhalation, the central part of the tape will be applied over the T10 with a tension of 50% to 70%. As the patient exhales and stretches the trunk, the ends of the tape will be attached to the lower ribs with a tension of 10 to 15%.
The supine position will be used in the Kinesiological taping of the right and left external oblique and internal oblique muscles. The application will be carried out for 6 weeks, 3 days a week, for 30 minutes daily. Receives: Other: core stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Function Tests
Respiratory functions will be measured using portable spirometry.
Measured: 5 min
Muscle Thickness Measurement With Ultrasound
Using external oblique (EO), Internal oblique (IO), Transversus abdominis (TrA), rectus abdominis muscles (RA) and diaphragm thickness, ultrasonic imaging system (M-TurboTM, Sono Site Canada, Inc., Markham, ON, Canada) It will be measured. A 5-2 MHz linear probe will be used to measure EO, IO, TrA and RA, and a 5-2 MHz convex probe for diaphragm measurement.
Measured: 10 min
Maximum inspiratory and expiratory oral pressures
Respiratory muscle strength will be assessed by measuring maximal inspiratory and expiratory pressures.
Measured: 1 min
Secondary outcomes (10)
Brunnstrom Evaluation Scale
Brunnstrom consists of 3 parts: The hand is scored on a 6-level Likert-type scale, in the form of upper and lower extremity sections. Higher levels represent better motor function. Disease stages are graded based on the patient's spasticity and movement.
Measured: 1 min
10 Meter Walk Test
Subjects are told to walk 14 meters. The middle 10 meters of 14 meters should be marked on the ground. Measurement begins when the patient crosses the line indicating the start of the 10 m path on the floor. After 10 meters, the stopwatch is stopped, but continues until the patient reaches the end of 14 meters. Subjects are told to walk at their preferred walking speed.
Measured: 1 min
Trunk Impairment Scale
Trunk Impairment Scale (TIS) is a valid and reliable sequential scale for measuring dynamic sitting balance, trunk coordination and trunk control. It evaluates the selective movements of lateral flexion and trunk rotation initiated from the upper and lower parts of the trunk. SMS consists of three subgroups: static settlement balance, dynamic settlement balance and coordination. Each sub-dimension contains three to ten items. TIS score is between 0 and 23.
Measured: 5 min
Stroke Impact Scale
Stroke Impact Scale (ISS) has been developed to be a more comprehensive measure of health outcomes for stroke populations. IES includes meaningful dimensions of function and health-related quality of life in the form of a self-assessment questionnaire. The 3rd version of the ISS includes 59 items and 8 sub-sections (power, hand function, activities and independent activities of daily life, mobility, communication, emotion, memory and thinking and participation / role function) and evaluates.
Measured: 10 min
Functional Ambulation Scale
Functional ambulation scale consisting of a sensitive and reliable scale for gait evaluation in stroke patients will be evaluated. On this scale, the score can range from 0 (being unable to walk or needing the help of two therapists) to 5 (being independent during the movement).
Measured: 1 min
Fatigue Severity Scale
The fatigue severity scale is a 9-item survey that investigated the severity of fatigue in different situations over the past week.
Measured: 1 min
Postural Evaluation Scale for Patients with Stroke
Postural Evaluation Scale for Patients with Stroke (PASS) It is specially designed for paralyzed patients. PASS contains a total of 12 items to assess balance. It contains 5 items to evaluate posture (static PASS) and 7 items to evaluate changes in posture (dynamic PASS). PASS can be used to evaluate functional balance that requires both static and dynamic balance. Each PASS item is rated from 0 to 3 for a 36-point survey. At this scale, the higher the score, the more positive the balance in stroke patients.
Measured: 3 min
Peak Cough Flow Rate
In the study, the highest cough flow rate will be measured with a portable PEF meter. All measurements will be made by a trained physiotherapist using the technique described by Fiore et al. Subjects will be asked to "take a deep breath and cough as hard as possible" in a semi-sitting position (60 degrees).
Measured: 2 min
Tinetti Balance Scale
The Tinetti Rating scale is a scale of 0 to 2 rows. 0 points represent the most disorder and 2 points represent independence. Individual points are then combined to form three subsections; overall gait assessment score, overall balance assessment score, and combined gait and balance score. The maximum score for the walking component is 12. The maximum score for the balance component is 16. The maximum total score is 28. In general, participants who score below 19 have a high risk of falling. It indicates that the participants who scored between 19-24 are at risk of falling medium.
Measured: 5 min
Timed Up and Go Test
It measures the time it takes for a person to stand up from a seat, walk a distance of 3 m, turn, sit back on the chair. It is a scale originally developed as a clinical measure of balance in the elderly and scored between 1 and 5 on the basis of an observer's perception of the participant's risk of falling during the test. Podsiadlo and Richardson timed the test and changed the original test and suggested using it as a short test of basic mobility skills for the elderly living in the weak community.
Measured: 2 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start4 May 2021
- Primary completion8 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stroke, CardiovascularStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Parallel groups
- Model description
- Group 1, core stabilization exercises group; Group 2, core stabilization exercises + electrical stimulation group; Group 3, core stabilization exercises + kinesiological banding group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdurrahim Yi̇ldi̇z, Istanbul University - Cerrahpasa
- Investigators
- Rüstem Mustafaoğlu, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777955
- Sponsor's protocol ID
- 123
- Status last verified
- Aug 2022
- First submitted
- 1 Mar 2021
- Last updated
- 29 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim 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 28284044Jung JH, Kim NS. The correlation between diaphragm thickness, diaphragmatic excursion, and pulmonary function in patients with chronic stroke. J Phys Ther Sci. 2017 Dec;29(12):2176-2179. doi: 10.1589/jpts.29.2176. Epub 2017 Dec 13.
PubMed 29643599Porcari JP, Miller J, Cornwell K, Foster C, Gibson M, McLean K, Kernozek T. The effects of neuromuscular electrical stimulation training on abdominal strength, endurance, and selected anthropometric measures. J Sports Sci Med. 2005 Mar 1;4(1):66-75. eCollection 2005 Mar 1.
PubMed 24431963Lee J, Jeon J, Lee D, Hong J, Yu J, Kim J. Effect of trunk stabilization exercise on abdominal muscle thickness, balance and gait abilities of patients with hemiplegic stroke: A randomized controlled trial. NeuroRehabilitation. 2020;47(4):435-442. doi: 10.3233/NRE-203133.
PubMed 33136074Haruyama K, Kawakami M, Otsuka T. Effect of Core Stability Training on Trunk Function, Standing Balance, and Mobility in Stroke Patients. Neurorehabil Neural Repair. 2017 Mar;31(3):240-249. doi: 10.1177/1545968316675431. Epub 2016 Nov 9.
PubMed 27821673Sharma V, Kaur J. Effect of core strengthening with pelvic proprioceptive neuromuscular facilitation on trunk, balance, gait, and function in chronic stroke. J Exerc Rehabil. 2017 Apr 30;13(2):200-205. doi: 10.12965/jer.1734892.446. eCollection 2017 Apr.
PubMed 28503533
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Core Stabilization Exercises With Swissball, Neuromuscular Electrical Stimulation and Kinesiology Taping in Stroke Patients
- ClinicalTrials.gov ID
- NCT04777955
- Acronym / sponsor ID
- 123
- Conditions
- Stroke, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 8 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 2 Mar 2021 (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.
Stroke is often associated with secondary complications such as nutritional and metabolic disorders, endocrine dysfunction, mental problems, and cardiopulmonary disorders caused by neurological and musculoskeletal deficits. The absence of the paretic side muscles and the difficulty of movement together with restrictive pulmonary disorders trigger a secondary decrease in cardiopulmonary function and expose insufficient energy associated with gait resulting in a decrease in asymmetric trunk exercise endurance.
Detailed description
Studies have shown that these patients have muscle weakness and delayed activity of trunk muscles, significant loss of trunk position sense, insufficient pressure control center while sitting, decreased trunk performance, and trunk asymmetry during walking. It has been reported that trunk function with balance and walking ability in stroke patients is a useful determinant of daily life activities, balance and walking ability. Balance disorders may be the result of changes in the sensory and integrative aspects of motor control. In the subacute phase, more than 80% of the subjects who have had stroke for the first time have an imbalance in their balance. After a stroke, upper motor neuron damage can cause unconditioned. This results in physical inactivity and decreased cardiorespiratory fitness. Respiratory muscle weakness and changes in thoraco-abdominal motion may be associated with a decrease in tidal volume and lower exercise tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Group 1, core stabilization exercises group; Group 2, core stabilization exercises + electrical stimulation group; Group 3, core stabilization exercises + kinesiological banding group.
| Arm | Type | Receives |
|---|---|---|
| Group 1, core stabilization exercises group | Experimental | Other: core stabilization exercisescore stabilization exercises will be performed using swissball. Program: Sitting on the ball will include (weight shifts, forward, backward and lateral sides), (pelvic bridge), (curl-up), (curlsup with diagonal reaching), (bird-dog exercise), (push-up) exercises. The application will be carried out for 6 weeks, 3 days a week for 30-45 minutes daily. |
| Group 2, electrical stimulation | Experimental | Other: core stabilization exercisesAn adaptation of a pre-designed protocol will be used for the application of the Normocular Electrical Stimulation in the diaphragm. Current to be applied; Synchronous impulse at 30 Hz frequency, 1 sec beat increase time, 1 sec "on" (muscle contraction), 1 sec beat reduction time and 20 sec "off" (no warning) time. Two channels, each with two electrodes, will be placed in the seventh and eighth anterior intercostal space above and below the right and left sides of the xiphoid protrusion. The other two channels, each with two electrodes, will be placed on the right and left midaxillary line of the seventh and eighth anterior intercostal space. The application will be carried out for 6 weeks, 3 days a week, for 30 minutes daily. |
| group 3, kinesiotape | Experimental | Other: core stabilization exercisesFor anterior diaphragm banding, the patient will stand with arms raised. Next, the central part of the tape will be applied to the xiphoid protrusion with a tension of 50% to 70% after the maximum inhalation. While the patient is breathing, the ends of the tape will be pulled with 10 to 15% tension towards the lower ribs. To tape the rear diaphragm, the patient's body will bend forward, and the arms will be joined crosswise over the chest. After the maximum inhalation, the central part of the tape will be applied over the T10 with a tension of 50% to 70%. As the patient exhales and stretches the trunk, the ends of the tape will be attached to the lower ribs with a tension of 10 to 15%. The supine position will be used in the Kinesiological taping of the right and left external oblique and internal oblique muscles. The application will be carried out for 6 weeks, 3 days a week, for 30 minutes daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral and first time stroke
- Ability to understand and follow verbal instructions
- Brunnstrom healing phase being above 3 for lower limbs;
- Ability to walk 10 m distance independently, with or without a mobility assistant.
- Patients who can sit on a stable surface for 30 seconds
Key exclusion criteria (7 listed)
- Neurological disorders other than stroke that could potentially affect balance and ambulation;
- Body failure scale score below 10 points
- Apraxia and hemineglect
- 80 years and older
- Orthopedic disorders or rib fracture
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 |
|---|---|---|
| core stabilization exercisesAlso: electrical stimulation, kinesiological bandingCore is at the center of almost all kinetic chains in the body. Core force, balance, and motion control maximize all kinetic chains of upper and lower limb function. A stable and strong core can contribute to more efficient use of the lower extremities. Core stability is defined as the ability of the lumbo-pelvic hip complex to prevent bending of the vertebral column and return to balance after perturbation. Neuromuscular electrical stimulation (NMES) is a technique in which muscle contraction is electrically stimulated in the area where the surface electrodes are connected. It improves secondary muscle atrophy and weakness in immobilization by preventing a decrease in muscle protein synthesis. Kinesiological banding (CT) is a treatment method used in the treatment of various musculoskeletal and neuromuscular deficits. The mechanism of action of CT is to facilitate muscle activation, increase blood and lymph circulation and reduce pain due to neurological suppression. | Other | Group 1, core stabilization exercises group, Group 2, electrical stimulation, group 3, kinesiotape |
Primary outcome
Respiratory Function Tests
Time frame: 5 min
Respiratory functions will be measured using portable spirometry.
Muscle Thickness Measurement With Ultrasound
Time frame: 10 min
Using external oblique (EO), Internal oblique (IO), Transversus abdominis (TrA), rectus abdominis muscles (RA) and diaphragm thickness, ultrasonic imaging system (M-TurboTM, Sono Site Canada, Inc., Markham, ON, Canada) It will be measured. A 5-2 MHz linear probe will be used to measure EO, IO, TrA and RA, and a 5-2 MHz convex probe for diaphragm measurement.
Maximum inspiratory and expiratory oral pressures
Time frame: 1 min
Respiratory muscle strength will be assessed by measuring maximal inspiratory and expiratory pressures.
10 secondary outcomes
Brunnstrom Evaluation Scale
Time frame: 1 min
10 Meter Walk Test
Time frame: 1 min
Trunk Impairment Scale
Time frame: 5 min
Stroke Impact Scale
Time frame: 10 min
Functional Ambulation Scale
Time frame: 1 min
Fatigue Severity Scale
Time frame: 1 min
Postural Evaluation Scale for Patients with Stroke
Time frame: 3 min
Peak Cough Flow Rate
Time frame: 2 min
Tinetti Balance Scale
Time frame: 5 min
Timed Up and Go Test
Time frame: 2 min
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 29 Aug 2022.
- Results publication: 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.
- Results publication: PubMed 29643599Jung JH, Kim NS. The correlation between diaphragm thickness, diaphragmatic excursion, and pulmonary function in patients with chronic stroke. J Phys Ther Sci. 2017 Dec;29(12):2176-2179. doi: 10.1589/jpts.29.2176. Epub 2017 Dec 13.
- Results publication: PubMed 24431963Porcari JP, Miller J, Cornwell K, Foster C, Gibson M, McLean K, Kernozek T. The effects of neuromuscular electrical stimulation training on abdominal strength, endurance, and selected anthropometric measures. J Sports Sci Med. 2005 Mar 1;4(1):66-75. eCollection 2005 Mar 1.
- Results publication: PubMed 33136074Lee J, Jeon J, Lee D, Hong J, Yu J, Kim J. Effect of trunk stabilization exercise on abdominal muscle thickness, balance and gait abilities of patients with hemiplegic stroke: A randomized controlled trial. NeuroRehabilitation. 2020;47(4):435-442. doi: 10.3233/NRE-203133.
- Results publication: PubMed 27821673Haruyama K, Kawakami M, Otsuka T. Effect of Core Stability Training on Trunk Function, Standing Balance, and Mobility in Stroke Patients. Neurorehabil Neural Repair. 2017 Mar;31(3):240-249. doi: 10.1177/1545968316675431. Epub 2016 Nov 9.
- Results publication: PubMed 28503533Sharma V, Kaur J. Effect of core strengthening with pelvic proprioceptive neuromuscular facilitation on trunk, balance, gait, and function in chronic stroke. J Exerc Rehabil. 2017 Apr 30;13(2):200-205. doi: 10.12965/jer.1734892.446. eCollection 2017 Apr.
- 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.
Rüstem Mustafaoğlu principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core stabilization exercises in people with Stroke, Cardiovascular, run by Istanbul University - Cerrahpasa 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 6 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 29 Aug 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?
Respiratory Function Tests (time frame: 5 min). The study lists 3 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 NCT04777955, which also lists 6 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 29 Aug 2022.