StrokeNCT05958732
Effect of Body Awarness Therapy on Balance and Coordination in Stroke
A study testing Somato-sensorial exercises therapy and Conventional Therapy in people with Stroke, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.
Trial summary
Stroke is sudden disruption in central nervous system function due to disturbance of the blood flow circulation in the brain. Cerebrovascular accident (CVA), is the second most leading cause of mortality (5.5 million cases yearly). Its occurrence remains high, with 13.7 million annual incident cases globally. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Somato-sensorial exercises therapy and Conventional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 9 May 2023to 31 Jul 2023
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female gender.
- Sub-acute hemiplegic stroke patients.
- Age 30 or older.
Who cannot join
- Other comorbid conditions.
- Neurological diseases other than stroke are excluded
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shifa Tameer-e-Millat University Islamabad
Islamabad, Fedral, 44000
Manan Haider, +923334839819, m_manan.drs@stmu.edu.pk
About this study
Stroke is sudden disruption in central nervous system function due to disturbance of the blood flow circulation in the brain. Cerebrovascular accident (CVA), is the second most leading cause of mortality (5.5 million cases yearly). Its occurrence remains high, with 13.7 million annual incident cases globally. Ischemic strokes are more common with a prevalence ratio of 76-119 per 100,000 per year worldwide ). Stroke is a neurological disease that decrease sensorimotor functions by causing irreversible impairments to the nervous system due to cerebral vascular problems . Patients with balance and activity disturbance are indicated by reduce in body functions. It is very essential for CVA patients to improve balance stability and muscle power for recovery and for normal activities ). Balance is an essential factor for independent living. It is maintained by adjusting COG (Center of Gravity) over the BOS (Base of Support). These adjustments are done through sensational inputs from the vestibular, visual and somatosensory system and are maintained by brain.
Read the detailed description
Impairment of balance stability is common in stroke patients. Patients with cerebrovascular accident (CVA) present mainly with asymmetric standing balance that affects their stability limits, and leads to major difficulty in functional independence. A reduction in maintaining balance is one of the major element that adversely affect after stroke. Coordination is another important factor, which allows a person to perform purposeful movement. After cerebrovascular accidents mainly impairment in coordination may be an element in mobility and movement limitations. Restoring the coordinated movement after cerebrovascular accident in important in regaining normal living activities. Those patients who survive from stroke may experience instant changes in thinking, language, balance, coordination, proprioception, body functions and quality of life. Stroke rehabilitation is the restoring functions of the impaired body regions and it is a long and time taking process, both for patients and for rehabilitation teams. Body awareness therapy (BAT) is a physiotherapeutic restorative approach that examine the patient's condition and focus towards relearning self-awareness movements. Body awareness therapy helps in strengthening the patient and also performing in activities of daily living (ADLs). A basic movement is stimulation of center line by weight shifting from right towards left and rotatory movements around the center of body and vice versa. Movements can be achieved in supine, sitting and standing position. Unfortunately, no randomized controlled trial (RCT) study has so far evaluated the effect of body awareness therapy (BAT) on balance and coordination in stroke survivals. Therefore, the purpose of this study is to assess BAT on balance and coordination in patients with cerebrovascular accident (CVA).
- Conditions
- Stroke
- Being tested
- Somato-sensorial exercises therapy, Conventional Therapy
- Keywords
- Stroke, Balance,, Coordination, mini-mental scale, BBS, Cognition
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somato-sensorial exercises therapyOther
It includes exercises, which is already mentioned in the arm description.
Conventional TherapyOther
It Includes routine exercises for the stroke patient the detail is already given in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will receive body awareness therapy for 20 minutes.The following steps will be conducted, (1) Put your left hand on your right toe. (2) Put your right hand on your left toe. (3) Touch your heels. (4) Put your feet together. (5) Put your knees together. (6) Touch your right knee with your left hand. (7) Touch your left knee with your right hand. (8) Touch one knee and one foot. (9) Put your right hand on your left knee. (10) Put your left hand on your right knee. (11) Put your feet apart. (12) Touch your toes with your arms crossed. (13) Touch your thumbs to your toes. (14) Bend your knees. (15) Stamp your feet. Duration is 5 days a week for two weeks. Along with conventional therapy. Receives: Other: Somato-sensorial exercises therapy; Other: Conventional Therapy |
| Control group | Other | conventional training plan: (1) 5 minute warm up then, (2) static balance exercises, such as, Two leg stance, One Leg stance, and (3) dynamic balance exercises such as, sideway walking with crossover, Forward walking or running in a zigzag line, Backward walking or running in a zigzag line, Jogging end to end, (4) Coordination exercises such as, Tandem stepping, Finger to nose, Finger to finger, Sitting with Shifting weight in all directions, Rebound Phenomenon and cool down for 5 minutes. Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
The assessment tests need individual corporation and the assessment is about 15 to 20 minutes. Berg Balance Scale involves 14 different tasks that can be categorized into different domains. Each task is divided into five grades for assessing the level of stability and un-stability and grades are from zero to four. Zero is graded when the person is unable and not performing the task fully and four is given when the person is fully able and able to perform the task independently. However, the score of the Berg balance scale ranges from 0 to 56. The score can be calculated or measured after assessment. From zero to twenty (0-20) severe impairment. From score Twenty-one to forty (21-40) moderate impairment. From score forty-one to fifty-six (41-56) minimal impairment.
Measured: 2 weeks
Co-ordination
The tests that can be performed to measure the coordination of the upper region and the lower region can be equilibrium and non-equilibrium tests.
The non-Equilibrium test is a simple and very effective clinical assessment screening test and would be assessed as the Finger nose test, Finger Finger Test, and Rebound Phenomena. For the lower limb heel-to-shin test, draw a circle test.
Equilibrium tests can be performed in a sitting position, in a standing position, and in a walking position. Coordination tests whether equilibrium or non-equilibrium can be assessed into five grades from 0 grade to 4 grade. Grade 0 (Activity Impossible) Grade 1 (severe Impairment) Grade 2 (moderate Impairment) Grade 3 (Minimal Impairment) Grade 4 ( normal Performance).
Measured: 2 weeks
Cognition
The Mini-Mental State examination is used to check cognition, and orientation, registration, attention and calculation, and memory recall of the objects. The score of the mini-mental state examination ranges between 0 to 30. If the score ranges between thirty to twenty-four (30 to 24) then there is no cognitive impairment. If the score ranges between twenty-three to eighteen (23 to 18) then there is mild cognitive impairment. If the score ranges between seventeen to zero (17-0) then an individual is suffering from severe cognitive impairment.
Measured: 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start9 May 2023
- Primary completion25 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Experimental group will be receiving conventional therapy and body awareness therapy for 30 minutes, 5 days a week for two weeks. Balance and coordination is measured before the treatment and after two weeks of treatment session it is again measured. control group will receive conventional physical therapy treatment for 30 minutes, 5 days a week for two weeks. Balance and coordination is measured before the treatment and after two weeks of treatment session it is again measured.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa Tameer-e-Millat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouman Khan, Shifa Tameer-e-Millat University
- Investigators
- Roshneck Haneed, MS-PT*, Principal investigator, Shifa Tameer-e-Millat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958732
- Sponsor's protocol ID
- IRB 0352-22
- Status last verified
- Jul 2023
- First submitted
- 9 May 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bang DH, Cho HS. Effect of body awareness training on balance and walking ability in chronic stroke patients: a randomized controlled trial. J Phys Ther Sci. 2016 Jan;28(1):198-201. doi: 10.1589/jpts.2016.198. Epub 2016 Jan 30.
PubMed 26957757Barclay RE, Stevenson TJ, Poluha W, Semenko B, Schubert J. Mental practice for treating upper extremity deficits in individuals with hemiparesis after stroke. Cochrane Database Syst Rev. 2020 May 25;5(5):CD005950. doi: 10.1002/14651858.CD005950.pub5.
PubMed 32449959Choi JU, Kang SH. The effects of patient-centered task-oriented training on balance activities of daily living and self-efficacy following stroke. J Phys Ther Sci. 2015 Sep;27(9):2985-8. doi: 10.1589/jpts.27.2985. Epub 2015 Sep 30.
PubMed 26504340Doost MY, Orban de Xivry JJ, Herman B, Vanthournhout L, Riga A, Bihin B, Jamart J, Laloux P, Raymackers JM, Vandermeeren Y. Learning a Bimanual Cooperative Skill in Chronic Stroke Under Noninvasive Brain Stimulation: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Jun;33(6):486-498. doi: 10.1177/1545968319847963. Epub 2019 May 15.
PubMed 31088342Kass B, Dornquast C, Meisel A, Holmberg C, Rieckmann N, Reinhold T. Cost-effectiveness of patient navigation programs for stroke patients-A systematic review. PLoS One. 2021 Oct 15;16(10):e0258582. doi: 10.1371/journal.pone.0258582. eCollection 2021.
PubMed 34653188Kim JC, Lim JH. The effects of coordinative locomotor training on coordination and gait in chronic stroke patients: a randomized controlled pilot trial. J Exerc Rehabil. 2018 Dec 27;14(6):1010-1016. doi: 10.12965/jer.1836386.193. eCollection 2018 Dec.
PubMed 30656163Kutlay S, Genc A, Gok H, Oztuna D, Kucukdeveci AA. Kinaesthetic ability training improves unilateral neglect and functional outcome in patients with stroke: A randomized control trial. J Rehabil Med. 2018 Feb 13;50(2):159-164. doi: 10.2340/16501977-2301.
PubMed 29209731Lindvall MA, Anderzen Carlsson A, Forsberg A. Basic Body Awareness Therapy for patients with stroke: Experiences among participating patients and physiotherapists. J Bodyw Mov Ther. 2016 Jan;20(1):83-89. doi: 10.1016/j.jbmt.2015.06.004. Epub 2015 Jun 15.
PubMed 26891641Yoo J, Jeong J, Lee W. The effect of trunk stabilization exercise using an unstable surface on the abdominal muscle structure and balance of stroke patients. J Phys Ther Sci. 2014 Jun;26(6):857-9. doi: 10.1589/jpts.26.857. Epub 2014 Jun 30.
PubMed 25013283
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Awarness Therapy on Balance and Coordination in Stroke
- ClinicalTrials.gov ID
- NCT05958732
- Acronym / sponsor ID
- IRB 0352-22
- Conditions
- Stroke
- Keywords
- Stroke, Balance,, Coordination, mini-mental scale, BBS, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Shifa Tameer-e-Millat UniversityUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 25 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 25 Jul 2023 (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 sudden disruption in central nervous system function due to disturbance of the blood flow circulation in the brain. Cerebrovascular accident (CVA), is the second most leading cause of mortality (5.5 million cases yearly). Its occurrence remains high, with 13.7 million annual incident cases globally. Ischemic strokes are more common with a prevalence ratio of 76-119 per 100,000 per year worldwide ). Stroke is a neurological disease that decrease sensorimotor functions by causing irreversible impairments to the nervous system due to cerebral vascular problems . Patients with balance and activity disturbance are indicated by reduce in body functions. It is very essential for CVA patients to improve balance stability and muscle power for recovery and for normal activities ). Balance is an essential factor for independent living. It is maintained by adjusting COG (Center of Gravity) over the BOS (Base of Support). These adjustments are done through sensational inputs from the vestibular, visual and somatosensory system and are maintained by brain.
Detailed description
Impairment of balance stability is common in stroke patients. Patients with cerebrovascular accident (CVA) present mainly with asymmetric standing balance that affects their stability limits, and leads to major difficulty in functional independence. A reduction in maintaining balance is one of the major element that adversely affect after stroke. Coordination is another important factor, which allows a person to perform purposeful movement. After cerebrovascular accidents mainly impairment in coordination may be an element in mobility and movement limitations. Restoring the coordinated movement after cerebrovascular accident in important in regaining normal living activities. Those patients who survive from stroke may experience instant changes in thinking, language, balance, coordination, proprioception, body functions and quality of life. Stroke rehabilitation is the restoring functions of the impaired body regions and it is a long and time taking process, both for patients and for rehabilitation teams. Body awareness therapy (BAT) is a physiotherapeutic restorative approach that examine the patient's condition and focus towards relearning self-awareness movements. Body awareness therapy helps in strengthening the patient and also performing in activities of daily living (ADLs). A basic movement is stimulation of center line by weight shifting from right towards left and rotatory movements around the center of body and vice versa. Movements can be achieved in supine, sitting and standing position. Unfortunately, no randomized controlled trial (RCT) study has so far evaluated the effect of body awareness therapy (BAT) on balance and coordination in stroke survivals. Therefore, the purpose of this study is to assess BAT on balance and coordination in patients with cerebrovascular accident (CVA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental group will be receiving conventional therapy and body awareness therapy for 30 minutes, 5 days a week for two weeks. Balance and coordination is measured before the treatment and after two weeks of treatment session it is again measured. control group will receive conventional physical therapy treatment for 30 minutes, 5 days a week for two weeks. Balance and coordination is measured before the treatment and after two weeks of treatment session it is again measured.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Somato-sensorial exercises therapy, Other: Conventional TherapyThe experimental group will receive body awareness therapy for 20 minutes.The following steps will be conducted, (1) Put your left hand on your right toe. (2) Put your right hand on your left toe. (3) Touch your heels. (4) Put your feet together. (5) Put your knees together. (6) Touch your right knee with your left hand. (7) Touch your left knee with your right hand. (8) Touch one knee and one foot. (9) Put your right hand on your left knee. (10) Put your left hand on your right knee. (11) Put your feet apart. (12) Touch your toes with your arms crossed. (13) Touch your thumbs to your toes. (14) Bend your knees. (15) Stamp your feet. Duration is 5 days a week for two weeks. Along with conventional therapy. |
| Control group | Other | Other: Conventional Therapyconventional training plan: (1) 5 minute warm up then, (2) static balance exercises, such as, Two leg stance, One Leg stance, and (3) dynamic balance exercises such as, sideway walking with crossover, Forward walking or running in a zigzag line, Backward walking or running in a zigzag line, Jogging end to end, (4) Coordination exercises such as, Tandem stepping, Finger to nose, Finger to finger, Sitting with Shifting weight in all directions, Rebound Phenomenon and cool down for 5 minutes. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both male and female gender.
- Sub-acute hemiplegic stroke patients.
- Age 30 or older.
Key exclusion criteria (3 listed)
- Other comorbid conditions.
- Neurological diseases other than stroke are excluded
- Severe cognitive 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 |
|---|---|---|
| Somato-sensorial exercises therapyIt includes exercises, which is already mentioned in the arm description. | Other | Experimental Group |
| Conventional TherapyIt Includes routine exercises for the stroke patient the detail is already given in the arm description. | Other | Control group, Experimental Group |
Primary outcome
Balance
Time frame: 2 weeks
The assessment tests need individual corporation and the assessment is about 15 to 20 minutes. Berg Balance Scale involves 14 different tasks that can be categorized into different domains. Each task is divided into five grades for assessing the level of stability and un-stability and grades are from zero to four. Zero is graded when the person is unable and not performing the task fully and four is given when the person is fully able and able to perform the task independently. However, the score of the Berg balance scale ranges from 0 to 56. The score can be calculated or measured after assessment. From zero to twenty (0-20) severe impairment. From score Twenty-one to forty (21-40) moderate impairment. From score forty-one to fifty-six (41-56) minimal impairment.
Co-ordination
Time frame: 2 weeks
The tests that can be performed to measure the coordination of the upper region and the lower region can be equilibrium and non-equilibrium tests. The non-Equilibrium test is a simple and very effective clinical assessment screening test and would be assessed as the Finger nose test, Finger Finger Test, and Rebound Phenomena. For the lower limb heel-to-shin test, draw a circle test. Equilibrium tests can be performed in a sitting position, in a standing position, and in a walking position. Coordination tests whether equilibrium or non-equilibrium can be assessed into five grades from 0 grade to 4 grade. Grade 0 (Activity Impossible) Grade 1 (severe Impairment) Grade 2 (moderate Impairment) Grade 3 (Minimal Impairment) Grade 4 ( normal Performance).
Cognition
Time frame: 2 weeks.
The Mini-Mental State examination is used to check cognition, and orientation, registration, attention and calculation, and memory recall of the objects. The score of the mini-mental state examination ranges between 0 to 30. If the score ranges between thirty to twenty-four (30 to 24) then there is no cognitive impairment. If the score ranges between twenty-three to eighteen (23 to 18) then there is mild cognitive impairment. If the score ranges between seventeen to zero (17-0) then an individual is suffering from severe cognitive impairment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Background: PubMed 26957757Bang DH, Cho HS. Effect of body awareness training on balance and walking ability in chronic stroke patients: a randomized controlled trial. J Phys Ther Sci. 2016 Jan;28(1):198-201. doi: 10.1589/jpts.2016.198. Epub 2016 Jan 30.
- Background: PubMed 32449959Barclay RE, Stevenson TJ, Poluha W, Semenko B, Schubert J. Mental practice for treating upper extremity deficits in individuals with hemiparesis after stroke. Cochrane Database Syst Rev. 2020 May 25;5(5):CD005950. doi: 10.1002/14651858.CD005950.pub5.
- Background: PubMed 26504340Choi JU, Kang SH. The effects of patient-centered task-oriented training on balance activities of daily living and self-efficacy following stroke. J Phys Ther Sci. 2015 Sep;27(9):2985-8. doi: 10.1589/jpts.27.2985. Epub 2015 Sep 30.
- Background: PubMed 31088342Doost MY, Orban de Xivry JJ, Herman B, Vanthournhout L, Riga A, Bihin B, Jamart J, Laloux P, Raymackers JM, Vandermeeren Y. Learning a Bimanual Cooperative Skill in Chronic Stroke Under Noninvasive Brain Stimulation: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Jun;33(6):486-498. doi: 10.1177/1545968319847963. Epub 2019 May 15.
- Background: PubMed 34653188Kass B, Dornquast C, Meisel A, Holmberg C, Rieckmann N, Reinhold T. Cost-effectiveness of patient navigation programs for stroke patients-A systematic review. PLoS One. 2021 Oct 15;16(10):e0258582. doi: 10.1371/journal.pone.0258582. eCollection 2021.
- Background: PubMed 30656163Kim JC, Lim JH. The effects of coordinative locomotor training on coordination and gait in chronic stroke patients: a randomized controlled pilot trial. J Exerc Rehabil. 2018 Dec 27;14(6):1010-1016. doi: 10.12965/jer.1836386.193. eCollection 2018 Dec.
- Background: PubMed 29209731Kutlay S, Genc A, Gok H, Oztuna D, Kucukdeveci AA. Kinaesthetic ability training improves unilateral neglect and functional outcome in patients with stroke: A randomized control trial. J Rehabil Med. 2018 Feb 13;50(2):159-164. doi: 10.2340/16501977-2301.
- Background: PubMed 26891641Lindvall MA, Anderzen Carlsson A, Forsberg A. Basic Body Awareness Therapy for patients with stroke: Experiences among participating patients and physiotherapists. J Bodyw Mov Ther. 2016 Jan;20(1):83-89. doi: 10.1016/j.jbmt.2015.06.004. Epub 2015 Jun 15.
- Background: PubMed 25013283Yoo J, Jeong J, Lee W. The effect of trunk stabilization exercise using an unstable surface on the abdominal muscle structure and balance of stroke patients. J Phys Ther Sci. 2014 Jun;26(6):857-9. doi: 10.1589/jpts.26.857. Epub 2014 Jun 30.
- 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.
Roshneck Haneed, MS-PT* principal investigator
Shifa Tameer-e-Millat 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 Somato-sensorial exercises therapy and Conventional Therapy in people with Stroke, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Jul 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manan Haider, PhD (+923334839810, m_manan.drs@stmu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 2 weeks). 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 NCT05958732, which also lists 9 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 25 Jul 2023.