Cerebral PalsyNCT04403490
Effect of HABIT-ILE on the Body Function and Structures of Children With Cerebral Palsy
A study testing HABIT-ILE and Conventional intervention in people with Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
There is strong evidence that recent intensive interventions based on motor skill learning principles are efficient on functional and neuroplastic changes of children with cerebral palsy (CP). 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?
- HABIT-ILE and Conventional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 26 May 2020to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed bilateral and unilateral cerebral palsy,
- MACS levels from I to IV,
- GMFCS levels from I to IV,
- Ability to follow instructions and complete testing.
Who cannot join
- Orthopedic surgery, botulinum toxin injections or another unusual intervention less than 6 months before or within the study period.
- Unstable seizure
- Severe visual or cognitive impairments likely to interfere with intervention or testing session completion
Trial locations and contacts
1 site in 1 country.
Seyma Kilcioglu, PhD Student contact
Belgium1 site, 1 recruiting
- Recruiting
Institute of Neuroscience, UCLouvain
Brussels, 1200
Yannick Bleyenheuft, Pr, yannick.bleyenheuft@uclouvain.be
Seyma Kilcioglu, PhD Student, seyma.kilcioglu@student.uclouvain.be
About this study
Official title: Effect of Hand and Arm Bimanual Intensive Therapy Including Lower Extremities on the Body Function and Structures of Children With Bilateral and Unilateral Cerebral Palsy, Including Selective Voluntary Motor Control and Brain Structure
There is strong evidence that recent intensive interventions based on motor skill learning principles are efficient on functional and neuroplastic changes of children with cerebral palsy (CP).
Besides, impaired selective voluntary motor control (SVMC) is one of four interrelated neuromuscular deficits in children with CP and is listed in the ICF-CY (International Classification of Functioning, Disability and Health for Children and Youth) under body functions. Additionally, impaired SVMC has been shown to negatively affect the motor and functional abilities of children with CP. However, there have been little scientific investigations on the trainability of SVMC according to therapeutic interventions.
Therefore, the study aims to evaluate the effect of Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on the body function and structures of children with bilateral and unilateral cerebral palsy, including SVMC and brain structure.
- Conditions
- Cerebral Palsy
- Being tested
- HABIT-ILE, Conventional intervention
- Keywords
- motor skill learning, body function, body structure, selective voluntary motor control, brain structure, neuroplasticity, intensive therapy, cerebral palsy
- 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-ILEBehavioural
2 weeks HABIT-ILE
Conventional interventionBehavioural
2 weeks usual intervention (waitlist group)
| Study group | Role | What they receive |
|---|---|---|
| HABIT-ILE | Experimental | Hand and arm bimanual intensive therapy including lower extremities Receives: Behavioral: HABIT-ILE |
| Conventional intervention | Active comparator | Conventional physical and occupational therapy Receives: Behavioral: Conventional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Diffusion Tensor Imaging (DTI)
This sequence allows to measure changes in the fractional anisotropy (FA) on the white matter tracts. FA is a scalar value (no unit) between zero and one that describes the degree of anisotropy of white matter water molecules.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Test of Arm Selective Control (TASC)
The TASC is an upper limb selective motor control evaluation tool including eight motions in each arm and up to three attempts are allowed for each motion. This assessment tool was developed in 2010 and Sukal-Moulton et al. have proved its validity and reliability for children with CP in 2017. After completion of the best attempt, points ranging from 0 (absent), 1 (impaired) to 2 (normal) are recorded for each joint depending on the movement properties and descriptors of the test.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Selective Control Assessment of the Lower Extremity (SCALE):
The SCALE was designed to evaluate lower limb selective motor control of children with cerebral palsy. The SCALE includes testing of five reciprocal lower extremity movements. SVMC is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Strength
The strength will be measured for main muscle groups using a Microfet.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Stiffness
The stiffness will be measured using a device developed and already validated at UCLouvain.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Secondary outcomes (25)
Changes in Assisting Hand Assessment (AHA or BoHA)
The AHA is a videotaped tool measuring how effectively children with unilateral CP use the affected hand in bimanual activities. The BoHA is a videotaped tool measuring how effectively children with bilateral CP use both hands in bimanual activities.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in ABILHAND-Kids Questionnaire
The ABILHAND-Kids Questionnaire has been developed to assess a child's unimanual and bimanual upper limb activities. It ranges from - 6 to +6 logits (higher score means better performance).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in ACTIVLIM-CP Questionnaire
The ACTIVLIM-CP Questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or the lower limbs through 42 items specific to patients with cerebral palsy. It ranges from - 5 to +5 logits (higher score means better performance).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Gross Motor Function Measurement (GMFM 66)
The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in 6 Minutes Walking Test (6MWT)
The 6 Minutes Walking Test measures the distance that the patient walk as much as possible within a period of 6-minutes in a 30 meters long corridor.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Box and Blocks test
The BBT is a test of gross manual dexterity. Each hand is tested individually and the BBT is scored through the number of blocks carried over the partition from one part to another part of a box during the one-minute trial period.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Jebsen-Taylor Test
The Jebsen-Taylor Test assesses uni-manual hand function, through 7 subtests simulating daily life activities. The test assesses speed, not quality of performance and time to complete each activity is reported using a stopwatch.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Modified Cooper test
The Modified Cooper test is a modified version of The Manual Form Perception Test, which evaluates stereognosis through 16 objects. Both hands are tested separately and time to recognise the objects is reported using a stopwatch.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in ABILOCO-Kids Questionnaire
The ABILOCO-Kids Questionnaire measures a patient's ability to perform daily activities requiring the use of the lower limbs through 10 items specific to patients with cerebral palsy. It ranges from - 4 to +4 logits (higher score means better performance).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
The PEDI-CAT is the new version of the Pediatric Evaluation of Disability Inventory (PEDI). The PEDI-CAT is comprised of 276 functional activities acquired throughout infancy, childhood and young adulthood. Based on the nternational Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) model, the PEDI-CAT contents provide information about the activities and participation component. It ranges from 0 to 100% (higher score means better performance).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Canadian Occupational Performance Measure (COPM)
The COPM measures the patient's self-perception of occupational performance and satisfaction of it in daily activities over time. It ranges from 1 to 10, a higher score means a better performance.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Double Inversion Recovery (DIR)
This sequence allows to identify an inflamatory lesion.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Functional resting state (RS)
This sequence allows to evaluate the regional interactions that occur in a resting or task-negative state.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in T1-weighted and T2-weighted structural imaging
The difference between these sequences allows to evaluated changes in the cortical myelin.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Executive Functions
Cognitive functions of the children will be assessed by Stroop task and Flanker task.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in spatial parameters of the gait (Kinematics assessments)
Through a 3D motion system, we measure the stride length (meters), step length (meters) and step width (meters).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Cycle time)
Through a 3D motion system, we measure the cycle of gait time (seconds).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Stance time)
Through a 3D motion system, we measure the stance time (percentage of the total gait cycle).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Swing time)
Through a 3D motion system, we measure the swing time (percentage of the total gait cycle).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Stride)
Through a 3D motion system, we measure the gait cadence (stride per minute).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Velocity)
Through a 3D motion system, we measure the gait velocity (meter/second).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Acceleration)
Through a 3D motion system, we measure the gait acceleration (meters/second^2)
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in spatial parameters of the upper extremity (Straightness)
Through a 3D motion system, we measure the straightness (percentage of upper extremity trajectory during a reaching task).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in spatial parameters of the upper extremity (Smoothness)
Through a 3D motion system, we measure the smoothness (variability of the movement during a reaching task)
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the upper extremity (Kinematics assessments)
Through a 3D motion system, we measure the time from onset to end of the task (seconds). the task consists in a bimanual reaching task.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start26 May 2020
- Primary completion20 Nov 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannick Bleyenheuft, Université Catholique de Louvain
- Investigators
- Yannick Bleyenheuft, Principal investigator, Institute of Neuroscience, UCLouvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403490
- Sponsor's protocol ID
- B403201316810f
- Status last verified
- Jun 2022
- First submitted
- 20 May 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hand and Arm Bimanual Intensive Therapy Including Lower Extremities on the Body Function and Structures of Children With Bilateral and Unilateral Cerebral Palsy, Including Selective Voluntary Motor Control and Brain Structure
- ClinicalTrials.gov ID
- NCT04403490
- Acronym / sponsor ID
- B403201316810f
- Conditions
- Cerebral Palsy
- Keywords
- motor skill learning, body function, body structure, selective voluntary motor control, brain structure, neuroplasticity, intensive therapy, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 27 May 2020 (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.
There is strong evidence that recent intensive interventions based on motor skill learning principles are efficient on functional and neuroplastic changes of children with cerebral palsy (CP).
Besides, impaired selective voluntary motor control (SVMC) is one of four interrelated neuromuscular deficits in children with CP and is listed in the ICF-CY (International Classification of Functioning, Disability and Health for Children and Youth) under body functions. Additionally, impaired SVMC has been shown to negatively affect the motor and functional abilities of children with CP. However, there have been little scientific investigations on the trainability of SVMC according to therapeutic interventions.
Therefore, the study aims to evaluate the effect of Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on the body function and structures of children with bilateral and unilateral cerebral palsy, including SVMC and brain structure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HABIT-ILE | Experimental | Behavioral: HABIT-ILEHand and arm bimanual intensive therapy including lower extremities |
| Conventional intervention | Active comparator | Behavioral: Conventional interventionConventional physical and occupational therapy |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed bilateral and unilateral cerebral palsy,
- MACS levels from I to IV,
- GMFCS levels from I to IV,
- Ability to follow instructions and complete testing.
Key exclusion criteria (3 listed)
- Orthopedic surgery, botulinum toxin injections or another unusual intervention less than 6 months before or within the study period.
- Unstable seizure
- Severe visual or cognitive impairments likely to interfere with intervention or testing session completion
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-ILE2 weeks HABIT-ILE | Behavioural | HABIT-ILE |
| Conventional intervention2 weeks usual intervention (waitlist group) | Behavioural | Conventional intervention |
Primary outcome
Changes in Diffusion Tensor Imaging (DTI)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
This sequence allows to measure changes in the fractional anisotropy (FA) on the white matter tracts. FA is a scalar value (no unit) between zero and one that describes the degree of anisotropy of white matter water molecules.
Changes in Test of Arm Selective Control (TASC)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
The TASC is an upper limb selective motor control evaluation tool including eight motions in each arm and up to three attempts are allowed for each motion. This assessment tool was developed in 2010 and Sukal-Moulton et al. have proved its validity and reliability for children with CP in 2017. After completion of the best attempt, points ranging from 0 (absent), 1 (impaired) to 2 (normal) are recorded for each joint depending on the movement properties and descriptors of the test.
Changes in Selective Control Assessment of the Lower Extremity (SCALE):
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
The SCALE was designed to evaluate lower limb selective motor control of children with cerebral palsy. The SCALE includes testing of five reciprocal lower extremity movements. SVMC is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points).
Changes in Strength
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
The strength will be measured for main muscle groups using a Microfet.
Changes in Stiffness
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
The stiffness will be measured using a device developed and already validated at UCLouvain.
25 secondary outcomes
Changes in Assisting Hand Assessment (AHA or BoHA)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in ABILHAND-Kids Questionnaire
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in ACTIVLIM-CP Questionnaire
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Gross Motor Function Measurement (GMFM 66)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in 6 Minutes Walking Test (6MWT)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Box and Blocks test
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Jebsen-Taylor Test
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Modified Cooper test
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in ABILOCO-Kids Questionnaire
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Canadian Occupational Performance Measure (COPM)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Double Inversion Recovery (DIR)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Functional resting state (RS)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in T1-weighted and T2-weighted structural imaging
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in Executive Functions
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in spatial parameters of the gait (Kinematics assessments)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Cycle time)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Stance time)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Swing time)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Stride)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Velocity)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Acceleration)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in spatial parameters of the upper extremity (Straightness)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in spatial parameters of the upper extremity (Smoothness)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the upper extremity (Kinematics assessments)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
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.
Seyma Kilcioglu, PhD Student contact
Yannick Bleyenheuft principal investigator
Institute of Neuroscience, UCLouvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HABIT-ILE and Conventional intervention in people with Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.
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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 Yannick Bleyenheuft, Professor (+32 2 764 93 49, yannick.bleyenheuft@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Diffusion Tensor Imaging (DTI) (time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2022.