Cerebral PalsyNCT03940989
The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy (BCP)
A study testing HABIT-ILE in people with Cerebral Palsy, run by Shriners Hospitals for Children at 2 sites in United States.
Trial summary
A recent systematic review found that therapeutic interventions that apply principles of motor learning with intense practice improve functional upper extremity movement in children with unilateral CP. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- HABIT-ILE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2019to 31 Dec 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Bilateral Cerebral Palsy
- Gross Motor Function Classification System (GMFCS) levels II-IV
- Able to get up from a chair with standby assist
- Able to sit on a mat table with upper extremity support
- Ability to understand directions
- Ability to walk 10 steps with/without assistive device and standby assist
Show all 9Show fewer
- Ability to understand and speak english
- Willing to restrict Botox/Dysport use for 3 months prior to each of the 4 full assessments
- Willing to be randomized to either camp format
Who cannot join
- Traumatic Brain Injury
- Predominate Dystonia
- Predominate Athetosis
- Orthopedic surgery in the last year or plans during the study period
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Teachers College, Columbia University
New York, New York, 10027
Shriners Hospitals for Children
Portland, Oregon, 97239
About this study
A recent systematic review found that therapeutic interventions that apply principles of motor learning with intense practice improve functional upper extremity movement in children with unilateral CP. Evidence of efficacy for any treatment approach aimed at improving motor function in bilateral CP (the most prevalent form) is lacking. Preliminary investigation suggests that intensive (90 hours) goal-directed, task-specific training provided in a 3-week day camp format can improve functional movement of both the upper (UE) and lower extremity (LE) and postural control in children with BCP. To date, HABIT-ILE has only been provided in a day camp setting over several weeks. Implementing the dosing schedule of this promising intensive approach in a hospital setting requires innovative resource allocation (space and staff); thus, examining alternative delivery models is imperative. The purpose of this study is to conduct a multi-center randomized control trial (RCT) to determine whether 90 hours of HABIT-ILE improves functional motor skills, activity and motivation in children with BCP when dosed in a camp format at 6-hours/day, 5 days/week for three weeks and 6-hours/day, one day/week for 15 weeks.
Read the detailed description
Cerebral Palsy (CP) is the leading cause of childhood motor impairment with 1 in 323 American children affected. The resulting impaired motor function in individuals with CP limits their ability to independently perform many functional activities, and participate in academic, social, and leisure activities. Children with CP are referred to physical, occupational, and speech therapy at varying intensities (1-3x week) for years, depending on individual needs. While these therapeutic services are offered regularly, the clinical efficacy and optimal dosing parameters are being challenged. In a meta-analysis of all available therapeutic interventions for CP, just 5 had strong enough evidence to recommend implementation into clinical practice for children with unilateral CP (Novak et al. 2013) and no therapies had sufficient evidence of efficacy for treatment of upper (UE) or lower extremities (LE) in children with bilateral CP (BCP). The key features of interventions with proven evidence of clinical efficacy include: a motor learning approach involving active movement, an environment to shape desired movements, and a much higher treatment intensity than provided in weekly therapies. Despite BCP being the most prevalent subtype, the majority of the research evaluating the clinical efficacy and dosing parameters of therapeutic interventions has been determined in children with UCP with upper extremity approaches such as Constraint Induced Movement Therapy (CIMT) and Hand-Arm Bimanual Intensive Therapy (HABIT) demonstrating efficacy.
One promising therapy gaining interest and support for children with BCP is Hand-Arm Bimanual Intensive Therapy Including the Lower Extremities (HABIT-ILE). HABIT-ILE aims to improve upper and lower movement control by engaging the UE and LE during combined activities for many hours every day for 3 weeks. Preliminary investigation has demonstrated that children with BCP participating in a 90-hour HABIT-ILE day camp achieve improvement within the body function and structure, activity and participation levels of the International Classification of Functioning, Disability and Health (ICF). While intensive therapies, such as HABIT-ILE, are typically provided in a day camp setting over several weeks, implementing the dosing schedule of this promising intensive approach in a hospital setting requires innovative resource allocation (space and staff). In order to establish the efficacy of this approach for children with BCP, it is essential to further examine the efficacy of the 3-week HABIT-ILE camp format of delivery in a larger, multisite trial, in addition to examining whether an alternative model of intensity and resource allocation can demonstrate similar efficacy. The overall aim of the proposed work is to determine the effectiveness of two different dosing schedules of an intensive therapeutic intervention that applies motor learning to upper and lower extremity movement and postural control to improve functional motor skills, activity, and self-mastery in children with BCP. The specific aims are:
Specific Aim 1: To determine if there are significant gains and retention in functional motor skills, activity, and self-mastery in children with BCP receiving 90 hours of HABIT-ILE dosed in a camp format for 6-hours per day, 5 days per week for three weeks and for 6-hours a day, one day per week for 15 weeks.
Specific Aim 2: To determine whether the degree of involvement, age and self-mastery predict the magnitude and maintenance of change seen in children with BCP receiving 90 hours of HABIT-ILE dosed in a camp format for 6-hours per day, 5 days per week for three weeks and for 6-hours a day, one day per week for 15 weeks.
- Conditions
- Cerebral Palsy
- Being tested
- HABIT-ILE
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HABIT-ILEOther
Goal-directed, task-specific training for both the upper (UE) and lower extremity (LE) and postural control.
| Study group | Role | What they receive |
|---|---|---|
| 3-Week Camp | Experimental | Subject will participate in a HABIT-ILE camp format for 6-hours/day, 5 days/week for three weeks. Receives: Other: HABIT-ILE |
| 15-Week Camp | Experimental | Subject will participate in a HABIT-ILE camp format for 6-hours/day, one day/week for 15 weeks. Receives: Other: HABIT-ILE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gross Motor Function Measure (GMFM)
Objective assessment of crawling, kneeling, standing, walking, running, jumping.The GMFM is scored on a 4-point scale ranging from does not initiate (0) to completes (3). Each dimension is scored independently providing a measure of functional motor ability within the dimension.
Measured: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in Jebsen-Taylor Test of Hand Function
Objective test of hand function for activities of daily living. Scoring is based on time to perform the individual tasks and times are compared to normative tables with assessment by age and gender.
Measured: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in Pediatric Balance Scale
Assessment of Standing Balance. THE PBS is a 14 item performance based balance test which is scored on a 5-point scale ranging from a low of 0 to a maximum of 4, with a maximum score of 56.
Measured: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in Trunk Control Measurement Scale
The TCMS assesses trunk control during both static and dynamic sitting balance. Dynamic sitting is further divided into selective movement control and dynamic reaching. Higher scores indicate greater balance.
Measured: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Secondary outcomes (8)
Change in Box and Blocks
Grasping, transporting and releasing blocks. The test is performed three times for each hand and the mean number of blocks transferred in a minute from the trials will be used to assess gains in manual dexterity.
Measured: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in 2-minute walk
The total distance walked in 2 minutes will be used to assess changes in mobility.
Measured: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in ABILOCO
The ABILOCO-kids is a 10-item parent-report measure of locomotor ability for children with lower limb impairments. The items represent continuous progression in difficulty of the locomotor activity.
Measured: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in ABILHAND
The ABILHAND-kids is a 21-item parent-report measure of bimanual activity for children with CP. The bimanual activities demonstrate continuous progression in difficulty. Higher scores indicate greater ability.
Measured: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in Pediatric Evaluation of Disability Inventory (PEDI-CAT)
Parent questionnaire to assess both capability and performance of functional activities in self-care, mobility, and social function. Each of the three scales will be assessed separately to determine whether specific functional activity areas change with intervention. Higher scores indicate a higher functional level.
Measured: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in Dimensions of Mastery Questionnaire
The 45-item parent-report questionnaire assesses two elements of mastery motivation: instrumental (persistence at object-related tasks, social activities with adults, social interactions with peers, and gross motor tasks) and expressive (behavioral indicators of positive affect during or following tasks and negative reaction to failure). Subscale scores will be used to determine whether motivation impacts gains in functional motor skills and whether gains in functional motor skills impact the magnitude of motivation.
Measured: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in Canadian Occupational Performance Measure (COPM)
Semi-structured interview that enables and open dialogue between the patient/parent on issues of importance to the patient/parent. The COPM is an individualized measure designed to detect change in a child's self-reported occupational performance over time. Occupations are classified into three categories: self-care, productivity and leisure.
Measured: One assessment at Baseline will be used to define goals. Two end of study evaluations (EOS) one the week after completion of camp and a 6-month followup
Change in Functional and quantitative muscle strength
Measurement of muscle strength.Quantitative strength of the abductors, knee extensors, and ankle plantarflexors will be measured with a hand-held dynamometer. Functional assessments of standing heel rise, sit to stand and lateral steps ups will assess functional strength. Higher numbers indicate greater strength.
Measured: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Apr 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Collaborators
- Teachers College, Columbia University
- Responsible party
- Principal investigator, Susan Sienko, Shriners Hospitals for Children
- Investigators
- Susan Sienko, PhD, Principal investigator, Shriners Hospitals for Children-Portland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940989
- Sponsor's protocol ID
- 79142
- Status last verified
- Mar 2024
- First submitted
- 2 May 2019
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sienko SE, Buckon C, Metelski N, Carton de Tournai A, Bleyenheuft Y, Brandao M, Herard GA, Gordon AM. The Impact of Dosing Schedule on the Efficacy of Hand-Arm Bimanual Intensive Therapy Including the Lower Extremities (HABIT-ILE) in Children With Bilateral Cerebral Palsy. Neurorehabil Neural Repair. 2026 Apr 30:15459683261432091. doi: 10.1177/15459683261432091. Online ahead of print.
PubMed 42057736
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy (BCP)
- ClinicalTrials.gov ID
- NCT03940989
- Acronym / sponsor ID
- 79142
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Collaborators
- Teachers College, Columbia University
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 May 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.
A recent systematic review found that therapeutic interventions that apply principles of motor learning with intense practice improve functional upper extremity movement in children with unilateral CP. Evidence of efficacy for any treatment approach aimed at improving motor function in bilateral CP (the most prevalent form) is lacking. Preliminary investigation suggests that intensive (90 hours) goal-directed, task-specific training provided in a 3-week day camp format can improve functional movement of both the upper (UE) and lower extremity (LE) and postural control in children with BCP. To date, HABIT-ILE has only been provided in a day camp setting over several weeks. Implementing the dosing schedule of this promising intensive approach in a hospital setting requires innovative resource allocation (space and staff); thus, examining alternative delivery models is imperative. The purpose of this study is to conduct a multi-center randomized control trial (RCT) to determine whether 90 hours of HABIT-ILE improves functional motor skills, activity and motivation in children with BCP when dosed in a camp format at 6-hours/day, 5 days/week for three weeks and 6-hours/day, one day/week for 15 weeks.
Detailed description
Cerebral Palsy (CP) is the leading cause of childhood motor impairment with 1 in 323 American children affected. The resulting impaired motor function in individuals with CP limits their ability to independently perform many functional activities, and participate in academic, social, and leisure activities. Children with CP are referred to physical, occupational, and speech therapy at varying intensities (1-3x week) for years, depending on individual needs. While these therapeutic services are offered regularly, the clinical efficacy and optimal dosing parameters are being challenged. In a meta-analysis of all available therapeutic interventions for CP, just 5 had strong enough evidence to recommend implementation into clinical practice for children with unilateral CP (Novak et al. 2013) and no therapies had sufficient evidence of efficacy for treatment of upper (UE) or lower extremities (LE) in children with bilateral CP (BCP). The key features of interventions with proven evidence of clinical efficacy include: a motor learning approach involving active movement, an environment to shape desired movements, and a much higher treatment intensity than provided in weekly therapies. Despite BCP being the most prevalent subtype, the majority of the research evaluating the clinical efficacy and dosing parameters of therapeutic interventions has been determined in children with UCP with upper extremity approaches such as Constraint Induced Movement Therapy (CIMT) and Hand-Arm Bimanual Intensive Therapy (HABIT) demonstrating efficacy.
One promising therapy gaining interest and support for children with BCP is Hand-Arm Bimanual Intensive Therapy Including the Lower Extremities (HABIT-ILE). HABIT-ILE aims to improve upper and lower movement control by engaging the UE and LE during combined activities for many hours every day for 3 weeks. Preliminary investigation has demonstrated that children with BCP participating in a 90-hour HABIT-ILE day camp achieve improvement within the body function and structure, activity and participation levels of the International Classification of Functioning, Disability and Health (ICF). While intensive therapies, such as HABIT-ILE, are typically provided in a day camp setting over several weeks, implementing the dosing schedule of this promising intensive approach in a hospital setting requires innovative resource allocation (space and staff). In order to establish the efficacy of this approach for children with BCP, it is essential to further examine the efficacy of the 3-week HABIT-ILE camp format of delivery in a larger, multisite trial, in addition to examining whether an alternative model of intensity and resource allocation can demonstrate similar efficacy. The overall aim of the proposed work is to determine the effectiveness of two different dosing schedules of an intensive therapeutic intervention that applies motor learning to upper and lower extremity movement and postural control to improve functional motor skills, activity, and self-mastery in children with BCP. The specific aims are:
Specific Aim 1: To determine if there are significant gains and retention in functional motor skills, activity, and self-mastery in children with BCP receiving 90 hours of HABIT-ILE dosed in a camp format for 6-hours per day, 5 days per week for three weeks and for 6-hours a day, one day per week for 15 weeks.
Specific Aim 2: To determine whether the degree of involvement, age and self-mastery predict the magnitude and maintenance of change seen in children with BCP receiving 90 hours of HABIT-ILE dosed in a camp format for 6-hours per day, 5 days per week for three weeks and for 6-hours a day, one day per week for 15 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-Week Camp | Experimental | Other: HABIT-ILESubject will participate in a HABIT-ILE camp format for 6-hours/day, 5 days/week for three weeks. |
| 15-Week Camp | Experimental | Other: HABIT-ILESubject will participate in a HABIT-ILE camp format for 6-hours/day, one day/week for 15 weeks. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Diagnosis of Bilateral Cerebral Palsy
- Gross Motor Function Classification System (GMFCS) levels II-IV
- Able to get up from a chair with standby assist
- Able to sit on a mat table with upper extremity support
- Ability to understand directions
Key exclusion criteria (4 listed)
- Traumatic Brain Injury
- Predominate Dystonia
- Predominate Athetosis
- Orthopedic surgery in the last year or plans during the study period
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 |
|---|---|---|
| HABIT-ILEGoal-directed, task-specific training for both the upper (UE) and lower extremity (LE) and postural control. | Other | 15-Week Camp, 3-Week Camp |
Primary outcome
Change in Gross Motor Function Measure (GMFM)
Time frame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Objective assessment of crawling, kneeling, standing, walking, running, jumping.The GMFM is scored on a 4-point scale ranging from does not initiate (0) to completes (3). Each dimension is scored independently providing a measure of functional motor ability within the dimension.
Change in Jebsen-Taylor Test of Hand Function
Time frame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Objective test of hand function for activities of daily living. Scoring is based on time to perform the individual tasks and times are compared to normative tables with assessment by age and gender.
Change in Pediatric Balance Scale
Time frame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Assessment of Standing Balance. THE PBS is a 14 item performance based balance test which is scored on a 5-point scale ranging from a low of 0 to a maximum of 4, with a maximum score of 56.
Change in Trunk Control Measurement Scale
Time frame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
The TCMS assesses trunk control during both static and dynamic sitting balance. Dynamic sitting is further divided into selective movement control and dynamic reaching. Higher scores indicate greater balance.
8 secondary outcomes
Change in Box and Blocks
Time frame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in 2-minute walk
Time frame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in ABILOCO
Time frame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in ABILHAND
Time frame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in Pediatric Evaluation of Disability Inventory (PEDI-CAT)
Time frame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in Dimensions of Mastery Questionnaire
Time frame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Change in Canadian Occupational Performance Measure (COPM)
Time frame: One assessment at Baseline will be used to define goals. Two end of study evaluations (EOS) one the week after completion of camp and a 6-month followup
Change in Functional and quantitative muscle strength
Time frame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
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 28 Mar 2024.
- Derived from this study: PubMed 42057736Sienko SE, Buckon C, Metelski N, Carton de Tournai A, Bleyenheuft Y, Brandao M, Herard GA, Gordon AM. The Impact of Dosing Schedule on the Efficacy of Hand-Arm Bimanual Intensive Therapy Including the Lower Extremities (HABIT-ILE) in Children With Bilateral Cerebral Palsy. Neurorehabil Neural Repair. 2026 Apr 30:15459683261432091. doi: 10.1177/15459683261432091. Online ahead of print.
- 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.
Susan Sienko, PhD principal investigator
Shriners Hospitals for Children-Portland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HABIT-ILE in people with Cerebral Palsy, run by Shriners Hospitals for Children at 2 sites in United States.
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 9 inclusion and 4 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 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 in Gross Motor Function Measure (GMFM) (time frame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup). 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 NCT03940989, 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 28 Mar 2024.