Cerebral PalsyNCT04035954
Effects of Modified Pilates Exercises on Body Control, Gait and Function in Children With Cerebral Palsy
A study testing exercise in people with Cerebral Palsy, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
Children with cerebral palsy (CP) have limitations in postural reactions and antigravity movements. Trunk control is the determinant of posture, balance, walking and functional activities. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 30 Jul 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- To be diagnosed with CP at the level of GMFCS I-II-III between the ages of 5-18
- Not having any Btx / surgery in the last 6 months
- Lower extremity spasticity 1 and 1+ according to modified Ashworth score
- Signing the written informed consent form
- Who can follow verbal commands
Who cannot join
- Individuals with multiple disabilities (hearing, speaking, seeing)
- Individuals with any behavior disorder (Autism, etc.) / Mental problems
- Patients with congenital cardiorespiratory status
- Have received any specific core stabilization training over the last 6 months
- Mixed musculoskeletal / axial deformities
Trial locations and contacts
1 site in 1 country.
About this study
Children with cerebral palsy (CP) have limitations in postural reactions and antigravity movements. Trunk control is the determinant of posture, balance, walking and functional activities. Core stability connects deep abdominal muscles, spine, pelvis, and shoulder girdle to protect the posture and provides support for extremity movements. Pilates and core stabilization were associated with postural control in elderly, MS and stroke individuals and it was concluded that pilates caused an increase in trunk stabilization. There are not enough studies investigating the effectiveness of pilates exercises in CP. The aim of this study was to investigate the effects of modified pilates exercises on body control, gait and functionality in children with CP.
Read the detailed description
Postural control is the ability of the body to control its position in space for stability and orientation. Postural stability and balance are achieved by keeping the center of gravity of the body within the support surface. Stability can also occur with a static response when the body is stationary, and a dynamic response to internal or external perturbations when it is mobile. Antisipation of perturbation forces requires an effective core stabilization muscle activation as well as an effective integration of stimuli from different sensory systems. Trunk control is also provided by this relationship between neural systems and skeletal muscles. Children with CP show deficits in proximal muscle co-contraction and vertical posture stabilization, with limitations in postural reactions and antigravity movements. Trunk control is the determinant of balance, gait and functional activities from the early period. Core stability; it connects with deep abdominal muscles, spine, pelvis and shoulder girdle muscles to protect the posture and provide support for limb movement. During reaching out, stepping and sudden perturbations, the Transversus Abdominus muscle is activated primarily from other trunk and limb muscles, creating a core stability. Core activity includes not only spinal stability and power generation, but also many upper and lower extremity movements. Control is established by focusing on the transversus abdominis muscle by core stabilization training with Pilates, stabilization of trunk muscles. The proximal extremity muscles of the hip are also important to maintain the upright posture and maintain mobility. For example; hip abductor muscle strength compared to the knee and ankle muscles, walking variables and motor functions in children with CP were more correlated. Although the importance of walking was determined, activation patterns of trunk and hip muscles during walking were examined in a limited number of studies in individuals with CP. The effects of pilates on healthy adults, elderly, multiple sclerosis, stroke and musculoskeletal disorders were investigated and resulted in increased trunk stabilization.Therefore, it is thought that pilates can be applied in terms of muscle strength and postural control in children who can walk, stand independently, but need to develop some components for controlled movement. There are not enough studies investigating the effectiveness of pilates exercises in CP. The aim of this study was to investigate the effects of modified pilates exercises on body control, gait and function in children with CP.
- Conditions
- Cerebral Palsy
- Being tested
- exercise
- Keywords
- Cerebral Palsy, modified pilates, trunk, gait, function, core stability
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
The control group will continue the routine NDT: Neurodevelopmental Therapy-based physiotherapy program twice a week. The treatment group will participate in clinical pilates exercises for 2 hours / day for 1 hour / 8 weeks. They will also continue their weekly routine physiotherapy programs.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Active comparator | The control group will continue the routine physiotherapy program based on NDT: Neurodevelopmental Therapy twice a week, 2 days / 1 hour / day during 8 weeks. Receives: Other: exercise |
| Experimental | Experimental | The treatment group will participate in clinical pilates exercises 2 days / 1 hour / day during 8 weeks.They will also continue their weekly routine physiotherapy programs. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Prone Plank Test
Its a core stability performance test. Patients are asked to raise their trunk by giving weight to the forearms and toes while the prone and elbows are in the flexion position.It meausures core stability in this position.Subjects will be encouraged to maintain the isometric postures for prone plank position as long as possible. The length of time subjects could maintain the correct position was recorded.The longest time of 2 trials, to the nearest 0.1 second, will be used for data analysis.
Measured: first day of intervention and after the 8 weeks
Change of Side Plank Test
Its a core stability performance test. Patients are asked to raise their trunk by giving weight to the forearms and toes while the prone and elbows are in the flexion position.It meausures core stability in this position.Subjects will be encouraged to maintain the isometric postures side plank test position as long as possible. The length of time subjects could maintain the correct position was recorded.The longest time of 2 trials, to the nearest 0.1 second, will be used for data analysis.
Measured: first day of intervention and after the 8 weeks
Change of Modifiye Beiring Sorensen Test
Tests the endurance capacity of posterior spinal musculature. The subject is positioning in prone lying position with pelvis at edge of the treatment table with the pelvis and legs well stabilized either manually. Initially the subjects supports their upper extremity on stool/bench in front of table until they are instructed to cross their arm and assume a horizontal position which is to be maintained as long as possible. Total time (in seconds) for which he/she was able to maintain horizontal position (i.e. the time between the assumption of the horizontal position up to the moment when they lost the horizontal position), was manually recorded using digital stopwatch up to two decimal places.
Measured: first day of intervention and after the 8 weeks
Change of Abdominal Fatigue test
It measures the endurance of the anterior abdominal wall by asking the person to hold a sit- up position as long as they can. The subjects are required to sit on the test bench t and place the upper trunk against a support with an angle of 60 degree from the test bench. Both knee and hip are flexed to 90 degree .Both arms are folded across the chest with the hands placed on the opposite shoulder and toes are stabilized to the bed (either by manual support or by straps). The subjects are asked to maintain the body position while the supporting back support is withdrawn. The stopwatch is started at the moment, when the support is withdrawn. The stopwatch is stopping when the upper body fell below the 60 degree position.Time duration between these two points are recorded as the endurance holding score of the anterior abdominal muscle group.
Measured: first day of intervention and after the 8 weeks
Secondary outcomes (9)
Change of Sharman's core stabilite testi (PBU=Pressure Biofeedback Unit Test)
It is objective and clinically feasible method to evaluate core stability in the laboratory settings which uses a stabilizer Pressure Biofeedback Unit with its inflatable pad placed in the inflatable cell was placed centrally beneath the abdomen with the lower edge at the level of the anterior superior iliac spines while the subject is lying supine, and is inflated to certain pressure of 70 mm Hg.The person is asked to pull his belly in as much as he can in a tight pants. While this is observed, the development of any other movement strategy (breast swelling, breath holding, pelvis movement) is noted and inhibited. The pressure may drop 6-10mmHg from the limit line. After the start, the test is terminated when 10 repetitions and 10 seconds of contraction are formed. Times are measured with a stopwatch. At each contraction, the onset of PBU is 70 mmHg, pressure changes and averages after 10 contraction are calculated. No feedback is given to the patient during the measurement.
Measured: first day of intervention and after the 8 weeks
Change of Sit Ups Test
Its a core test of power. The patient is asked to perform trunk flexion while the knees are in the flexed position and the feet are stabilized.The number of sit ups it can perform in 30 seconds is recorded.
Measured: first day of intervention and after the 8 weeks
Change of Modified Push-ups Test
Its a core test of power. When the cases are in the prone position, the arms and elbows are asked to lift the head, shoulders, and trunk from the flexion with the elbows fully extended. During the test, the knees are positioned in flexion.The number of push ups it can perform in 30 seconds is recorded.
Measured: first day of intervention and after the 8 weeks
Change of 6 Minute Walk Test
The 6-minute walk test (6MWT) is a standardized, self-paced walking test commonly used to assess functional ability in children with cerebral palsy (CP).1 The test has been reported to reflect functional capacity in terms of activities of daily living.2 In a recent Delphi study3 surveying the views of 15 physical therapy and exercise physiology experts, the 6MWT has been recommended as a submaximal exercise test for children with CP of Gross Motor Function Classification System4 (GMFCS) levels I to III.
Measured: first day of intervention and after the 8 weeks
Change of Pediatric Reach Test (PRT)
PRT was developed and modified from Functional Reach Test which was originally developed for measuring standing functional reach in adult populations. Due to the consideration that many children with CP are only able to maintain the upright position in sitting, PRT is developed to measure the maximal reach distance of children with CP both in sitting and standing positions. The total score of PRT is the sum of scores of PRT during sitting and PRT during standing.
Measured: first day of intervention and after the 8 weeks
Change of Physician Rating Scale (PRS)
One of these instruments is the Physician Rating Scale (PRS), an observational clinical evaluation of gait. This simple scale records gait in the sagittal plane only. Gait variables are recorded in the subtitle of Crouch, Knee, Foot contact scoring and general Change. Several items are geared to quantify visually the relationship between the ankle and knee position during stance. Maximum total score is 10.Also maximum scores shows the better results.
Measured: first day of intervention and after the 8 weeks
Change of Berg Balance Scale (BBS)
The BBS is a simple measure with 14 items that can be completed within 20 minutes. These items are used to test functional skills relevant to everyday tasks, progressing from stable positions to position changes and finally to the upright position with various maneuvers to challenge balance. The items are scored on a 5-point ordinal scale from 0 to 4 (0-1-2-3-4). The highest score is 56 points; a higher score indicates a better functional balance performance.
Measured: first day of intervention and after the 8 weeks
Change of Seated Postural Control Measure (SPCM)
SPCM has two sections. One section examines postural alignment and consists of 22 items; the other section examines functional movement and consists of 12 items. The SPCM can be administered and scored in 20 minutes or less. An ordinal scale of 0 to 3 is used to score each segmental posture. A given deviation, whether to the right or the left, would receive the same score. Visual observation and palpation are the only methods used to estimate postural alignment. At the beginning of the assessment, the child is placed in the seat in what the assessing therapist considers an optimal position. Verbal encouragement (without manual support) to maintain a correct posture is given. Each of the items in the function section consists of four levels, with higher grades representing better task achievement (from zero to completion). A maximum of 1 minute is allowed for motivating the child and completing each item. If more than one attempt is made, the best performance is scored.
Measured: first day of intervention and after the 8 weeks
Change of Gross Motor Function Classification System (GMFCS)
The GMFCS is a common classification system and is an evidence-based classification tool of five levels ranging from level I, which includes children with minimal or no disability with respect to community mobility, to level V, which includes children who are totally dependent on external assistance for mobility.
Measured: first day of intervention and after the 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Aug 2019
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- The study will include16 children with cerebral palsy (SP) diagnosed at the GMFCS I-II-III level with 8 controls and 8 treatment groups by random minimization between 7-14 years of age with 1 and 1+ spasticity on the lower extremity according to the Modified Ashworth Score.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adıgüzel, Sanko University
- Investigators
- Hatice Adıgüzel, PhD cd., Principal investigator, Sanko UniversityBülent Elbasan, Ass. Prof., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035954
- Sponsor's protocol ID
- Sanko University
- Status last verified
- Apr 2021
- First submitted
- 24 Jul 2019
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adiguzel H, Elbasan B. Effects of modified pilates on trunk, postural control, gait and balance in children with cerebral palsy: a single-blinded randomized controlled study. Acta Neurol Belg. 2022 Aug;122(4):903-914. doi: 10.1007/s13760-021-01845-5. Epub 2022 Jan 18.
PubMed 35040072
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modified Pilates Exercises on Body Control, Gait and Function in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04035954
- Acronym / sponsor ID
- Sanko University
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, modified pilates, trunk, gait, function, core stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 29 Jul 2019 (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.
Children with cerebral palsy (CP) have limitations in postural reactions and antigravity movements. Trunk control is the determinant of posture, balance, walking and functional activities. Core stability connects deep abdominal muscles, spine, pelvis, and shoulder girdle to protect the posture and provides support for extremity movements. Pilates and core stabilization were associated with postural control in elderly, MS and stroke individuals and it was concluded that pilates caused an increase in trunk stabilization. There are not enough studies investigating the effectiveness of pilates exercises in CP. The aim of this study was to investigate the effects of modified pilates exercises on body control, gait and functionality in children with CP.
Detailed description
Postural control is the ability of the body to control its position in space for stability and orientation. Postural stability and balance are achieved by keeping the center of gravity of the body within the support surface. Stability can also occur with a static response when the body is stationary, and a dynamic response to internal or external perturbations when it is mobile. Antisipation of perturbation forces requires an effective core stabilization muscle activation as well as an effective integration of stimuli from different sensory systems. Trunk control is also provided by this relationship between neural systems and skeletal muscles. Children with CP show deficits in proximal muscle co-contraction and vertical posture stabilization, with limitations in postural reactions and antigravity movements. Trunk control is the determinant of balance, gait and functional activities from the early period. Core stability; it connects with deep abdominal muscles, spine, pelvis and shoulder girdle muscles to protect the posture and provide support for limb movement. During reaching out, stepping and sudden perturbations, the Transversus Abdominus muscle is activated primarily from other trunk and limb muscles, creating a core stability. Core activity includes not only spinal stability and power generation, but also many upper and lower extremity movements. Control is established by focusing on the transversus abdominis muscle by core stabilization training with Pilates, stabilization of trunk muscles. The proximal extremity muscles of the hip are also important to maintain the upright posture and maintain mobility. For example; hip abductor muscle strength compared to the knee and ankle muscles, walking variables and motor functions in children with CP were more correlated. Although the importance of walking was determined, activation patterns of trunk and hip muscles during walking were examined in a limited number of studies in individuals with CP. The effects of pilates on healthy adults, elderly, multiple sclerosis, stroke and musculoskeletal disorders were investigated and resulted in increased trunk stabilization.Therefore, it is thought that pilates can be applied in terms of muscle strength and postural control in children who can walk, stand independently, but need to develop some components for controlled movement. There are not enough studies investigating the effectiveness of pilates exercises in CP. The aim of this study was to investigate the effects of modified pilates exercises on body control, gait and function in children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will include16 children with cerebral palsy (SP) diagnosed at the GMFCS I-II-III level with 8 controls and 8 treatment groups by random minimization between 7-14 years of age with 1 and 1+ spasticity on the lower extremity according to the Modified Ashworth Score.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Active comparator | Other: exerciseThe control group will continue the routine physiotherapy program based on NDT: Neurodevelopmental Therapy twice a week, 2 days / 1 hour / day during 8 weeks. |
| Experimental | Experimental | Other: exerciseThe treatment group will participate in clinical pilates exercises 2 days / 1 hour / day during 8 weeks.They will also continue their weekly routine physiotherapy programs. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- To be diagnosed with CP at the level of GMFCS I-II-III between the ages of 5-18
- Not having any Btx / surgery in the last 6 months
- Lower extremity spasticity 1 and 1+ according to modified Ashworth score
- Signing the written informed consent form
- Who can follow verbal commands
Key exclusion criteria (5 listed)
- Individuals with multiple disabilities (hearing, speaking, seeing)
- Individuals with any behavior disorder (Autism, etc.) / Mental problems
- Patients with congenital cardiorespiratory status
- Have received any specific core stabilization training over the last 6 months
- Mixed musculoskeletal / axial deformities
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 |
|---|---|---|
| exerciseThe control group will continue the routine NDT: Neurodevelopmental Therapy-based physiotherapy program twice a week. The treatment group will participate in clinical pilates exercises for 2 hours / day for 1 hour / 8 weeks. They will also continue their weekly routine physiotherapy programs. | Other | Experimental, Interventional |
Primary outcome
Change of Prone Plank Test
Time frame: first day of intervention and after the 8 weeks
Its a core stability performance test. Patients are asked to raise their trunk by giving weight to the forearms and toes while the prone and elbows are in the flexion position.It meausures core stability in this position.Subjects will be encouraged to maintain the isometric postures for prone plank position as long as possible. The length of time subjects could maintain the correct position was recorded.The longest time of 2 trials, to the nearest 0.1 second, will be used for data analysis.
Change of Side Plank Test
Time frame: first day of intervention and after the 8 weeks
Its a core stability performance test. Patients are asked to raise their trunk by giving weight to the forearms and toes while the prone and elbows are in the flexion position.It meausures core stability in this position.Subjects will be encouraged to maintain the isometric postures side plank test position as long as possible. The length of time subjects could maintain the correct position was recorded.The longest time of 2 trials, to the nearest 0.1 second, will be used for data analysis.
Change of Modifiye Beiring Sorensen Test
Time frame: first day of intervention and after the 8 weeks
Tests the endurance capacity of posterior spinal musculature. The subject is positioning in prone lying position with pelvis at edge of the treatment table with the pelvis and legs well stabilized either manually. Initially the subjects supports their upper extremity on stool/bench in front of table until they are instructed to cross their arm and assume a horizontal position which is to be maintained as long as possible. Total time (in seconds) for which he/she was able to maintain horizontal position (i.e. the time between the assumption of the horizontal position up to the moment when they lost the horizontal position), was manually recorded using digital stopwatch up to two decimal places.
Change of Abdominal Fatigue test
Time frame: first day of intervention and after the 8 weeks
It measures the endurance of the anterior abdominal wall by asking the person to hold a sit- up position as long as they can. The subjects are required to sit on the test bench t and place the upper trunk against a support with an angle of 60 degree from the test bench. Both knee and hip are flexed to 90 degree .Both arms are folded across the chest with the hands placed on the opposite shoulder and toes are stabilized to the bed (either by manual support or by straps). The subjects are asked to maintain the body position while the supporting back support is withdrawn. The stopwatch is started at the moment, when the support is withdrawn. The stopwatch is stopping when the upper body fell below the 60 degree position.Time duration between these two points are recorded as the endurance holding score of the anterior abdominal muscle group.
9 secondary outcomes
Change of Sharman's core stabilite testi (PBU=Pressure Biofeedback Unit Test)
Time frame: first day of intervention and after the 8 weeks
Change of Sit Ups Test
Time frame: first day of intervention and after the 8 weeks
Change of Modified Push-ups Test
Time frame: first day of intervention and after the 8 weeks
Change of 6 Minute Walk Test
Time frame: first day of intervention and after the 8 weeks
Change of Pediatric Reach Test (PRT)
Time frame: first day of intervention and after the 8 weeks
Change of Physician Rating Scale (PRS)
Time frame: first day of intervention and after the 8 weeks
Change of Berg Balance Scale (BBS)
Time frame: first day of intervention and after the 8 weeks
Change of Seated Postural Control Measure (SPCM)
Time frame: first day of intervention and after the 8 weeks
Change of Gross Motor Function Classification System (GMFCS)
Time frame: first day of intervention and after the 8 weeks
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 13 Apr 2021.
- Derived from this study: PubMed 35040072Adiguzel H, Elbasan B. Effects of modified pilates on trunk, postural control, gait and balance in children with cerebral palsy: a single-blinded randomized controlled study. Acta Neurol Belg. 2022 Aug;122(4):903-914. doi: 10.1007/s13760-021-01845-5. Epub 2022 Jan 18.
- 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.
Hatice Adıgüzel, PhD cd. principal investigator
Sanko University
Bülent Elbasan, Ass. Prof. principal investigator
Gazi 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 exercise in people with Cerebral Palsy, run by Sanko 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 5 inclusion and 5 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 13 Apr 2021. 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?
Change of Prone Plank Test (time frame: first day of intervention and after the 8 weeks). The study lists 4 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 NCT04035954, which also lists 1 linked publication.
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 13 Apr 2021.