Specific Learning DisorderNCT05902143
Fine Motor Function in Children With Specific Learning Disorders
An observational study of Specific Learning Disorder, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Specific Learning Disorder (SLD) is a neurodevelopmental disorder in which a person shows difficulties in reading, written narration, and/or mathematics. 30 to 50 percent of children with SLD experience difficulties in fine motor skills, such as handwriting skills, and also during self-care activities and activities… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Specific Learning Disorder
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2023to 12 Feb 2024
- Phase
- Observational
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children with specific learning disorder and typically developing peers
Who may be able to join
- 6-12 years old
- Patients diagnosed with SLD by a physician, regardless of subtype.
- Cognitive ability to follow instructions for assessment measures
- Families and children who agreed to participate in the study
Who cannot join
- Any psychiatric diagnosis such as autism spectrum disorder, psychotic symptoms, depression
- Children with a neurological or orthopedic disorder such as head trauma, Cerebral Palsy, epileptic seizures and speech disorder
- Families and children who do not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
Ozgun Kaya Kara, Assoc. Prof. contact
About this study
Official title: Evaluation of Fine Motor Function in Children With Specific Learning Disorders
Specific Learning Disorder (SLD) is a neurodevelopmental disorder in which a person shows difficulties in reading, written narration, and/or mathematics. 30 to 50 percent of children with SLD experience difficulties in fine motor skills, such as handwriting skills, and also during self-care activities and activities that require sorting. This study will evaluate children with SLD and healthy ages within fine motor skills, handgrip strength, and hand-forearm anthropometric measurements. Our study will show the impact of the fine motor skills of children with SLD on their quality of life and participation in daily life activities. In light of our current knowledge, no study has been found that comprehensively examines the fine motor functions of children with SLD. Therefore, normative data on the upper extremity functions of children with SLD will be presented to the literature. In this context, our work will shed light on the development of new treatments and assessment methods for clinicians and researchers working with children with SLD.
Read the detailed description
Specific Learning Disorder (SLD) is a neurodevelopmental disorder in which the individual has difficulties in reading, written expression, and/or mathematics, according to the Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM-V). SLD; According to DSM-5, the academic difficulties experienced are explained in detail by dividing them into three subgroups. These are dyslexia, dyscalculia, and dysgraphia. The incidence of SLD is approximately 33% in girls and 67% in boys between the ages of 6-12. The ethology of SLD is multifactorial. It is associated with multiple genes and environmental risk factors. Structural imaging studies in children with SLD have revealed that grey matter is reduced. As a result of low grey matter, early literacy education seems to be negatively affected, and fine motor skills such as writing play an important role in this influence.
Writing is a complex activity that includes perceptual, motor, and cognitive processes. Writing activities require a high level of fine motor coordination, postural control, adjustable grip strength, visual perception, and language skills. Considering the studies, it is stated that children who go to primary school spend 31%-60% of their academic days with tasks involving fine motor skills, and most of them do activities such as writing and painting. In addition to their academic and writing performances, children with SLD perform differently in daily life compared to their healthy peers. In general, they have difficulties during self-care activities such as tying shoes, clipping their nails, buttoning/zipping, shaving, and performing activities that require sequencing. At the same time, children with SLD have difficulties in sensory processing, balance, and postural control. Difficulties in sensory processing, balance, and postural control seen in children with SLD affect proximal stability. When proximal stability is poor, distal movements cannot be performed in good quality. Therefore, adequate postural control and proximal stability are essential prerequisites for many activities of daily living. In the literature, it has been shown that grip strength and anthropometric characteristics of the upper extremity affect distal fine motor skills. In a study by Anakwe et al., it was shown that grip strength increased as the forearm circumference measurement value increased. In a study examining the relationship between hand grip and finger strength and anthropometric measurements, it was concluded that grip strength increased as arm and forearm measurements increased. It has been proven that grip strength increases as arm and forearm measurements increase.
In the light of our current knowledge, no study has been found that comprehensively examines the fine motor functions, hand and finger strengths, and anthropometric measurements of children with SLD. The primary aim of this study is to examine the fine motor skills, hand grip strength, and hand and forearm anthropometric characteristics of children with SLD compared to those of healthy children and to investigate their relationships with each other. The second aim of our study is to examine the effect of fine motor skills on quality of life and participation in activities at home, school, and community environment of children with SLD compared to their healthy peers.
- Conditions
- Specific Learning Disorder
- Keywords
- Specific Learning Disorder, Fine motor skills, Grip strength, Upper extremity, Children
- Medical subject headings
- Specific Learning Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | children with Specific Learning Disorder | |
| Control Group | children with typically developing children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2)
Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2) is norm referenced and designed to measure gross and fine motor skills in youth 4 to 21 years of age. Standard scores 40 are considered below average, whereas those >40 range from average to above average.
Measured: Baseline
Purdue Pegboard Test
The Purdue Pegboard Test consists of a board with four subtests: Dominant hand, Non-Dominant hand, Bimanual and Assembly. Each subtest was administered three times in a row. The dominant hand and non-dominant hand subtests required to place as many pegs as possible in the column corresponding to the hand being tested within 30-sec. The dominant hand is tested first followed by the non-dominant hand. In the bimanual subtest, both hands simultaneously placed a pair of pegs in both columns. The scores on these three tests were the pairs of pegs for the bimanual subtest, placed within 30-sec. The assembly subtest required picking up and placing pegs, washers, collars and second washers using alternating hands. This score represents the number of pieces assembled within 60-sec.
Measured: Baseline
Hand Dynamometer
Hand Dynamometer will be used to evaluate hand grip strength. Measurements will be performed in the position defined by the American Association of Hand Therapists. During the test, the child will be seated with a 90° flexion angle of the hip and knee. Three measurements will be made to measure the hand grip strength.
Measured: Baseline
Pinch Gauge
"Pinch Gauge" will be used to evaluate finger strength. Measurements will be performed in the position defined by the American Association of Hand Therapists. Finger strengths will be recorded by asking the children to grasp at maximal strength in the three basic types of fine grip. These are fingertip grip, lateral grip, and three-point grip positions, respectively.
Measured: Baseline
Secondary outcomes (2)
Participation and Environment Measurement Child & Youth (PEM-CY)
Participation and Environment Measurement Child \& Youth (PEM-CY) is a parent-report questionnaire to assess participation and environment factors in the home, at school and within community Settings. The participation sections included 10 activities in the home setting, five activities in the school setting and 10 in the community setting. For each activity, parents are asked to determine the participation frequency (how frequently has the child participated with eight options: daily to never), participation involvement (how involved the child is while participating the activity rated on a five-point scale: very involved to minimally involved) and whether change is desired (do the parents want to see change in the child's participation in this type of activity: no or yes, with 5 different types of change).
Measured: Baseline
The Pediatric Quality of Life Inventory (PEDS-QL)
The Pediatric Quality of Life Inventory (PEDS-QL) is a generic health related quality of life measure consisting of 4 core scales, physical function (8 items), emotional function (5 items), social function (5 items) and school function (5 items) that is intended for use in healthy and patient populations. Respondents are asked to recall the last month and indicate how frequently - from never to almost always - they have experienced specific phenomena. Item responses (0-100) are averaged to form total and core scores; higher scores indicate higher functioning.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start30 Jun 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion12 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Specific Learning DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgun Kaya Kara, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902143
- Sponsor's protocol ID
- 2022-297
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silver CH, Ruff RM, Iverson GL, Barth JT, Broshek DK, Bush SS, Koffler SP, Reynolds CR; NAN Policy and Planning Committee. Learning disabilities: the need for neuropsychological evaluation. Arch Clin Neuropsychol. 2008 Mar;23(2):217-9. doi: 10.1016/j.acn.2007.09.006. Epub 2007 Oct 30.
PubMed 17977692Rutter M, Caspi A, Fergusson D, Horwood LJ, Goodman R, Maughan B, Moffitt TE, Meltzer H, Carroll J. Sex differences in developmental reading disability: new findings from 4 epidemiological studies. JAMA. 2004 Apr 28;291(16):2007-12. doi: 10.1001/jama.291.16.2007.
PubMed 15113820Darki F, Peyrard-Janvid M, Matsson H, Kere J, Klingberg T. Three dyslexia susceptibility genes, DYX1C1, DCDC2, and KIAA0319, affect temporo-parietal white matter structure. Biol Psychiatry. 2012 Oct 15;72(8):671-6. doi: 10.1016/j.biopsych.2012.05.008. Epub 2012 Jun 9.
PubMed 22683091Raschle NM, Chang M, Gaab N. Structural brain alterations associated with dyslexia predate reading onset. Neuroimage. 2011 Aug 1;57(3):742-9. doi: 10.1016/j.neuroimage.2010.09.055. Epub 2010 Sep 25.
PubMed 20884362Goldstand S, Gevir D, Yefet R, Maeir A. Here's How I Write-Hebrew: Psychometric Properties and Handwriting Self-Awareness Among Schoolchildren With and Without Dysgraphia. Am J Occup Ther. 2018 Sep/Oct;72(5):7205205060p1-7205205060p9. doi: 10.5014/ajot.2018.024869.
PubMed 30157018Di Brina C, Averna R, Rampoldi P, Rossetti S, Penge R. Reading and Writing Skills in Children With Specific Learning Disabilities With and Without Developmental Coordination Disorder. Motor Control. 2018 Oct 1;22(4):391-405. doi: 10.1123/mc.2016-0006. Epub 2018 Feb 28.
PubMed 29488824McHale K, Cermak SA. Fine motor activities in elementary school: preliminary findings and provisional implications for children with fine motor problems. Am J Occup Ther. 1992 Oct;46(10):898-903. doi: 10.5014/ajot.46.10.898.
PubMed 1463061Moe-Nilssen R, Helbostad JL, Talcott JB, Toennessen FE. Balance and gait in children with dyslexia. Exp Brain Res. 2003 May;150(2):237-44. doi: 10.1007/s00221-003-1450-4. Epub 2003 Apr 8.
PubMed 12682807Cowley JC, Gates DH. Inter-joint coordination changes during and after muscle fatigue. Hum Mov Sci. 2017 Dec;56(Pt B):109-118. doi: 10.1016/j.humov.2017.10.015. Epub 2017 Nov 6.
PubMed 29121490Anakwe RE, Huntley JS, McEachan JE. Grip strength and forearm circumference in a healthy population. J Hand Surg Eur Vol. 2007 Apr;32(2):203-9. doi: 10.1016/J.JHSB.2006.11.003. Epub 2007 Jan 2.
PubMed 17197064
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fine Motor Function in Children With Specific Learning Disorders
- ClinicalTrials.gov ID
- NCT05902143
- Acronym / sponsor ID
- 2022-297
- Conditions
- Specific Learning Disorder
- Keywords
- Specific Learning Disorder, Fine motor skills, Grip strength, Upper extremity, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 12 Feb 2024 (estimated)
- First posted
- 13 Jun 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.
Specific Learning Disorder (SLD) is a neurodevelopmental disorder in which a person shows difficulties in reading, written narration, and/or mathematics. 30 to 50 percent of children with SLD experience difficulties in fine motor skills, such as handwriting skills, and also during self-care activities and activities that require sorting. This study will evaluate children with SLD and healthy ages within fine motor skills, handgrip strength, and hand-forearm anthropometric measurements. Our study will show the impact of the fine motor skills of children with SLD on their quality of life and participation in daily life activities. In light of our current knowledge, no study has been found that comprehensively examines the fine motor functions of children with SLD. Therefore, normative data on the upper extremity functions of children with SLD will be presented to the literature. In this context, our work will shed light on the development of new treatments and assessment methods for clinicians and researchers working with children with SLD.
Detailed description
Specific Learning Disorder (SLD) is a neurodevelopmental disorder in which the individual has difficulties in reading, written expression, and/or mathematics, according to the Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM-V). SLD; According to DSM-5, the academic difficulties experienced are explained in detail by dividing them into three subgroups. These are dyslexia, dyscalculia, and dysgraphia. The incidence of SLD is approximately 33% in girls and 67% in boys between the ages of 6-12. The ethology of SLD is multifactorial. It is associated with multiple genes and environmental risk factors. Structural imaging studies in children with SLD have revealed that grey matter is reduced. As a result of low grey matter, early literacy education seems to be negatively affected, and fine motor skills such as writing play an important role in this influence.
Writing is a complex activity that includes perceptual, motor, and cognitive processes. Writing activities require a high level of fine motor coordination, postural control, adjustable grip strength, visual perception, and language skills. Considering the studies, it is stated that children who go to primary school spend 31%-60% of their academic days with tasks involving fine motor skills, and most of them do activities such as writing and painting. In addition to their academic and writing performances, children with SLD perform differently in daily life compared to their healthy peers. In general, they have difficulties during self-care activities such as tying shoes, clipping their nails, buttoning/zipping, shaving, and performing activities that require sequencing. At the same time, children with SLD have difficulties in sensory processing, balance, and postural control. Difficulties in sensory processing, balance, and postural control seen in children with SLD affect proximal stability. When proximal stability is poor, distal movements cannot be performed in good quality. Therefore, adequate postural control and proximal stability are essential prerequisites for many activities of daily living. In the literature, it has been shown that grip strength and anthropometric characteristics of the upper extremity affect distal fine motor skills. In a study by Anakwe et al., it was shown that grip strength increased as the forearm circumference measurement value increased. In a study examining the relationship between hand grip and finger strength and anthropometric measurements, it was concluded that grip strength increased as arm and forearm measurements increased. It has been proven that grip strength increases as arm and forearm measurements increase.
In the light of our current knowledge, no study has been found that comprehensively examines the fine motor functions, hand and finger strengths, and anthropometric measurements of children with SLD. The primary aim of this study is to examine the fine motor skills, hand grip strength, and hand and forearm anthropometric characteristics of children with SLD compared to those of healthy children and to investigate their relationships with each other. The second aim of our study is to examine the effect of fine motor skills on quality of life and participation in activities at home, school, and community environment of children with SLD compared to their healthy peers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –children with Specific Learning Disorder |
| Control Group | – | –children with typically developing children |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children with specific learning disorder and typically developing peers
Key inclusion criteria (4 listed)
- 6-12 years old
- Patients diagnosed with SLD by a physician, regardless of subtype.
- Cognitive ability to follow instructions for assessment measures
- Families and children who agreed to participate in the study
Key exclusion criteria (3 listed)
- Any psychiatric diagnosis such as autism spectrum disorder, psychotic symptoms, depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2)
Time frame: Baseline
Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2) is norm referenced and designed to measure gross and fine motor skills in youth 4 to 21 years of age. Standard scores 40 are considered below average, whereas those >40 range from average to above average.
Purdue Pegboard Test
Time frame: Baseline
The Purdue Pegboard Test consists of a board with four subtests: Dominant hand, Non-Dominant hand, Bimanual and Assembly. Each subtest was administered three times in a row. The dominant hand and non-dominant hand subtests required to place as many pegs as possible in the column corresponding to the hand being tested within 30-sec. The dominant hand is tested first followed by the non-dominant hand. In the bimanual subtest, both hands simultaneously placed a pair of pegs in both columns. The scores on these three tests were the pairs of pegs for the bimanual subtest, placed within 30-sec. The assembly subtest required picking up and placing pegs, washers, collars and second washers using alternating hands. This score represents the number of pieces assembled within 60-sec.
Hand Dynamometer
Time frame: Baseline
Hand Dynamometer will be used to evaluate hand grip strength. Measurements will be performed in the position defined by the American Association of Hand Therapists. During the test, the child will be seated with a 90° flexion angle of the hip and knee. Three measurements will be made to measure the hand grip strength.
Pinch Gauge
Time frame: Baseline
"Pinch Gauge" will be used to evaluate finger strength. Measurements will be performed in the position defined by the American Association of Hand Therapists. Finger strengths will be recorded by asking the children to grasp at maximal strength in the three basic types of fine grip. These are fingertip grip, lateral grip, and three-point grip positions, respectively.
2 secondary outcomes
Participation and Environment Measurement Child & Youth (PEM-CY)
Time frame: Baseline
The Pediatric Quality of Life Inventory (PEDS-QL)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Background: PubMed 17977692Silver CH, Ruff RM, Iverson GL, Barth JT, Broshek DK, Bush SS, Koffler SP, Reynolds CR; NAN Policy and Planning Committee. Learning disabilities: the need for neuropsychological evaluation. Arch Clin Neuropsychol. 2008 Mar;23(2):217-9. doi: 10.1016/j.acn.2007.09.006. Epub 2007 Oct 30.
- Background: PubMed 15113820Rutter M, Caspi A, Fergusson D, Horwood LJ, Goodman R, Maughan B, Moffitt TE, Meltzer H, Carroll J. Sex differences in developmental reading disability: new findings from 4 epidemiological studies. JAMA. 2004 Apr 28;291(16):2007-12. doi: 10.1001/jama.291.16.2007.
- Background: PubMed 22683091Darki F, Peyrard-Janvid M, Matsson H, Kere J, Klingberg T. Three dyslexia susceptibility genes, DYX1C1, DCDC2, and KIAA0319, affect temporo-parietal white matter structure. Biol Psychiatry. 2012 Oct 15;72(8):671-6. doi: 10.1016/j.biopsych.2012.05.008. Epub 2012 Jun 9.
- Background: PubMed 20884362Raschle NM, Chang M, Gaab N. Structural brain alterations associated with dyslexia predate reading onset. Neuroimage. 2011 Aug 1;57(3):742-9. doi: 10.1016/j.neuroimage.2010.09.055. Epub 2010 Sep 25.
- Background: PubMed 30157018Goldstand S, Gevir D, Yefet R, Maeir A. Here's How I Write-Hebrew: Psychometric Properties and Handwriting Self-Awareness Among Schoolchildren With and Without Dysgraphia. Am J Occup Ther. 2018 Sep/Oct;72(5):7205205060p1-7205205060p9. doi: 10.5014/ajot.2018.024869.
- Background: PubMed 29488824Di Brina C, Averna R, Rampoldi P, Rossetti S, Penge R. Reading and Writing Skills in Children With Specific Learning Disabilities With and Without Developmental Coordination Disorder. Motor Control. 2018 Oct 1;22(4):391-405. doi: 10.1123/mc.2016-0006. Epub 2018 Feb 28.
- Background: PubMed 1463061McHale K, Cermak SA. Fine motor activities in elementary school: preliminary findings and provisional implications for children with fine motor problems. Am J Occup Ther. 1992 Oct;46(10):898-903. doi: 10.5014/ajot.46.10.898.
- Background: PubMed 12682807Moe-Nilssen R, Helbostad JL, Talcott JB, Toennessen FE. Balance and gait in children with dyslexia. Exp Brain Res. 2003 May;150(2):237-44. doi: 10.1007/s00221-003-1450-4. Epub 2003 Apr 8.
- Background: PubMed 29121490Cowley JC, Gates DH. Inter-joint coordination changes during and after muscle fatigue. Hum Mov Sci. 2017 Dec;56(Pt B):109-118. doi: 10.1016/j.humov.2017.10.015. Epub 2017 Nov 6.
- Background: PubMed 17197064Anakwe RE, Huntley JS, McEachan JE. Grip strength and forearm circumference in a healthy population. J Hand Surg Eur Vol. 2007 Apr;32(2):203-9. doi: 10.1016/J.JHSB.2006.11.003. Epub 2007 Jan 2.
- 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.
Ozgun Kaya Kara, Assoc. Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Specific Learning Disorder, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 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 13 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ishak Isık, Prof. Dr. (02422494400, etik.kurul.07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2) (time frame: Baseline). 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 NCT05902143, which also lists 10 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 13 Jun 2023.