- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04664673
HABIT-ILE in Adults With Chronic Stroke (HABIT-ILE Stroke)
June 16, 2022 updated by: Université Catholique de Louvain
Effect of the Intensive Intervention "Hand-Arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) in Chronic (> 6 Months) Adults With Acquired Brain Damage (Stroke)
Using a randomized controlled trial design, the possible changes induced by the intensive treatment program "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" will be studied in functional, everyday life activities and neuroplastic assessment of adults with chronic stroke.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Using a randomized controlled trial design, the possible changes in neuroimaging, motor function, motor learning and everyday life activities of adults with chronic stroke (> 6 months) after participating of the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) will be studied.
Changes, scored by participants in case of questionnaires and by experts in the case of tests, will be observed comparing participants after their regular care/treatment and after receiving HABIT-ILE.
Motor function, learning and daily life activities will be correlated with neuroplastic changes.
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daniela Ebner, PhD
- Phone Number: +3227645446
- Email: daniela.ebner@uclouvain.be
Study Contact Backup
- Name: Yves Vandermeeren, PhD
- Phone Number: +3281423321
- Email: yves.vandermeeren@uclouvain.be
Study Locations
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-
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Brussels, Belgium, 1200
- Recruiting
- Institute of Neuroscience, UCLouvain
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Contact:
- Daniela Ebner, PhD
- Phone Number: +3227645446
- Email: daniela.ebner@uclouvain.be
-
Contact:
- Yannick Bleyenheuft, Pr
- Phone Number: +3227645446
- Email: yannick.bleyenheuft@uclouvain.be
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- hemiparetic patient with a chronic stroke (over 6 months of evolution)
- age 40 to 90 years old inclusive
- ability to follow instructions and complete testing according to the age.
Exclusion Criteria:
- alcohol/drug abuse
- pregnancy
- major cognitive impairment interfering with the study (severe aphasia, psychiatric conditions)
- uncontrolled health issues (cardiac/renal failure)
- contraindications to perform MRI assessments (Metal implants, etc.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HABIT-ILE
HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks adapted for adults stroke survivors
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motor learning-based, intensive therapy originally developed for hemiplegic children.
Other Names:
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Active Comparator: Regular care
Usual customary treatment for adults stroke survivors during two weeks
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customary or usual treatment given to any adult stroke survivor
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
This assessment is an observation-based instrument assessing the effectiveness of the spontaneous use of the affected hand when performing bimanual activities in adults post stroke scored in a logit based 0-100 AHA-unit scale (higher score indicate higher ability)
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baseline, 3 weeks and 13 weeks after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes on speed/accuracy trade-off during a bimanual reaching task (bi-SAT)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
By using the Rehabilitation Robot System (REAplan®), we calculate the bi-SAT through mathematical computation
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baseline, 3 weeks and 13 weeks after baseline
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Changes on force during a bimanual reaching task (bi-Force)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
By using the REAplan® robot, we calculate the bimanual forces and forces exerted in the wrong direction by each arm (Newtons)
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baseline, 3 weeks and 13 weeks after baseline
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Changes on bimanual coordination during a bimanual reaching task (bi-CO)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
By using the REAplan® robot, we calculate the phase coherence between speeds of both arms
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baseline, 3 weeks and 13 weeks after baseline
|
Changes on bimanual smoothness during a bimanual reaching task (bi-smoothness)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
By using the REAplan® robot, we calculate the Spectral Arc Length (SPARC) of the movement (unitless)
|
baseline, 3 weeks and 13 weeks after baseline
|
Changes on errors during a bimanual reaching task (bi-error)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
By using the REAplan® robot, we calculate the amount of errors while performing the bimanual task (measured in centimeters or degrees)
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baseline, 3 weeks and 13 weeks after baseline
|
Changes in finger force tracking dexterity
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
By using a finger force manipulandum (DEXTRAIN), which records the forces (in Newtons) applied by the fingers on pistons, we calculate the ability to control and release the force applied by the fingers during a tracking task.
|
baseline, 3 weeks and 13 weeks after baseline
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Changes in multifinger tapping dexterity
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
By using the DEXTRAIN, we assess the independent finger movements while simultaneous tapping with different finger configurations (two fingers or one finger) in response to visual instructions during a finger tapping task.
The percentage of errors are considered.
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baseline, 3 weeks and 13 weeks after baseline
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Changes in cortical thickness of the brain's gray matter
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
Regional brain cortical thickness is acquired from high resolution 3D T1-weighted structural imaging data.
For each investigated region, mean cortical metrics (in millimeters) are assessed between the pial surface and the white/grey boundary.
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baseline, 3 weeks and 13 weeks after baseline
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Changes in Fractional Anisotropy (FA) of the corticospinal tract from the motor cortex to the cerebellar peduncle
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
FA is a scalar value (no unit) between 0 and 1 that describes the degree of anisotropy of white matter water molecules.
It is measured non-invasively via brain MRI using diffusion tensor imaging (DTI), a modality of Diffusion-Weighted Imaging (DWI).
Increased values indicate a higher directionality of the tissue structure.
|
baseline, 3 weeks and 13 weeks after baseline
|
Changes on the Axial, Radial and Mean Diffusivity (AD, RD, MD) of the corticospinal tract from the motor cortex to the cerebellar peduncle
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
AD, RD and MD are values ranging from 0 to 3.10-3 [mm2/s] that describe the degree of axial, radial and mean molecular diffusion of white matter water molecules.
It is measured non-invasively via brain MRI using diffusion tensor imaging (DTI), a modality of Diffusion-Weighted Imaging (DWI).
An increased MD can be considered to be an indicator of white matter damage.
|
baseline, 3 weeks and 13 weeks after baseline
|
Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the NODDI model
Time Frame: baseline, 3 weeks and 13 weeks after baseline
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The orientation dispersion index (ODI), intracellular volume fraction (ICVF) and the fraction of the isotropic compartment (ISOF) are scalar values ranging from 0 to 1 (no units) that describe the orientation of neural fibers, and the volume fraction of the intracellular and isotropic compartment.
It is measured non-invasively via brain MRI using the Neurite Orientation Dispersion and Density Imaging (NODDI) model combined with a Diffusion-Weighted Imaging (DWI) sequence.
The results reflects the overall coherence of the fibers, with zero representing highly coherent structures, hence less dispersion of the fibers.
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baseline, 3 weeks and 13 weeks after baseline
|
Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the DIAMOND model
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
By representing each voxel of the brain as the sum of multiple compartments (representing either a neural fiber population or an isotropic diffusion), the volume fraction and the heterogeneity of each compartment can be estimated.
These metrics (ranging from 0 to 1, no unit) are measured non-invasively via brain MRI using the Distribution of 3D Anisotropic Microstructural environments in Diffusion-compartment imaging (DIAMOND) model combined with a Diffusion-Weighted Imaging (DWI) sequence.
The results reflects the overall heterogeneity of the fibers, with zero representing more homogeny structures, hence less dispersion of the fibers.
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baseline, 3 weeks and 13 weeks after baseline
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Changes in resting-state functional connectivity
Time Frame: baseline, 3 weeks and 13 weeks after baseline
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Resting-state functional magnetic resonance imaging (rs-fMRI) evaluates the regional interactions that occur during the resting or task-negative state.
The magnitude of the brain activation during rs-fMRI will be assessed
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baseline, 3 weeks and 13 weeks after baseline
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Changes in brain white matter microstructure (WM-μs) using the Microstructure Fingerprinting model
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
Using a multiple-compartment approach, the signal obtained from a voxel can be estimated as the sum of multiple fiber populations, each presenting a specific fraction ('frac', ranging from 0 to 1, no unit), fiber volume fraction ('fvf', ranging from 0 to 1, no unit) and diffusivity ('diff', in [mm2/s]).
On top of those fiber populations, isotropic compartments can also be represented with a specific fraction (frac) and diffusivity (diff).
These metrics are measured non-invasively via brain MRI using the Microstructure Fingerprinting model combined with a Diffusion-Weighted Imaging (DWI) sequence.
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baseline, 3 weeks and 13 weeks after baseline
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Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
The FMA-UE assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia.
Maximum score is 66 points (Higher scores indicates better functioning levels)
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baseline, 3 weeks and 13 weeks after baseline
|
Changes in upper extremities motor functions assess by the Wolf Motor Function Test (WMFT)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
The WMFT measures quantitative motor ability through 17 timed and functional tasks.
Uses a 6-point ordinal scale (from 0= "does not attempt with the involved arm" to 5= "arm does participate; movement appears to be normal").
Maximum score is 75 (Higher scores indicates better functioning levels)
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baseline, 3 weeks and 13 weeks after baseline
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Changes in unimanual dexterity assessed by the Box & Block test (BBT)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
The BBT assess unimanual dexterity by quantifying the maximum of wooden blocks transferred from one space to the other during 1 minute (Higher scores indicate better performance)
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baseline, 3 weeks and 13 weeks after baseline
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Changes in the Six Minutes' Walk Test (6MWT)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
The 6MWT assess endurance while walking 6 minutes without pause.
More distance walked (in meters) indicate better performance
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baseline, 3 weeks and 13 weeks after baseline
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Changes in Canadian Occupational Performance Measure (COPM)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
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In this interview, patients set up 5 activities considered difficult in daily life.
These are then assessed, in a 1 to 10 scale, regarding the patient's self-perception of performance and satisfaction of it.
The total score is the average of the scores for perception and satisfaction separately (score from 1 to 10)
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baseline, 3 weeks and 13 weeks after baseline
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Changes in the Stroke Impact Scale (SIS)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
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Self-reported questionnaire assessing multidimensional repercussions of the Stroke (strength, hand function, daily life activities, mobility, communication, emotion, memory, thinking and participation).
Domains are scored on a metric of 0 to 100 (higher scores indicate better self-reported health)
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baseline, 3 weeks and 13 weeks after baseline
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Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire
Time Frame: baseline, 3 weeks and 13 weeks after baseline
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The ACTIVLIM-Stroke questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or lower extremities through 20 items specific to patients after stroke.
It ranges from - 6 to +6 logits (higher score means better performance).
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baseline, 3 weeks and 13 weeks after baseline
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Changes in activities of daily living assessed by ABILHAND Questionnaire
Time Frame: baseline, 3 weeks and 13 weeks after baseline
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The ABILHAND questionnaire specific to patients with chronic stroke measures a patient's manual ability to manage daily activities that require the use of the upper extremities, whatever the strategies involved, through 23 items.
It ranges from -6 to +6 logits (higher score means better performance).
|
baseline, 3 weeks and 13 weeks after baseline
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Changes in the modified Rankin Scale (mRS) for neurologic disability
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The 6 levels of disability goes from 0 ("no disability/no symptoms") to 5 ("disability requiring constant care for all needs"), being 6 "death".
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baseline, 3 weeks and 13 weeks after baseline
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Changes in visual neglect assessed by the Bells Test
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
The Bells Test is a cancellation test that allows for a quantitative and qualitative assessment of visual neglect in the near extra personal space.
The patient score is based on the amount of time they take to complete the task, and the number of correct items (35 bells) they identify.
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baseline, 3 weeks and 13 weeks after baseline
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Changes on the visuospatial short term working memory assessed by the "Corsi block-tapping test"
Time Frame: baseline, 3 weeks and 13 weeks after baseline
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The test requires the patient to observe and then repeat in order a sequence of blocks "tapped".
The task starts with a sequence of 2 blocks and gradually increases in length up to nine blocks.
The test measures both the number of correct sequences and the longest sequence remembered.
This number is known as the "Corsi Span", and averages about 5 for normal human subjects.
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baseline, 3 weeks and 13 weeks after baseline
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Changes in the Montreal Cognitive Assessment (MoCA) test
Time Frame: baseline, 3 weeks and 13 weeks after baseline
|
The MoCA is a brief screening instrument originally designed to identify mild cognitive impairments in elderly patients attending a memory clinic.
MoCA evaluates different domains (visuospatial abilities, executive functions, short-term memory recall, attention, concentration, working memory, language, and orientation to time and space) having a total of 30 points (higher scores indicate better self-reported health)
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baseline, 3 weeks and 13 weeks after baseline
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Changes in inhibitory control assessed by the Stroop Color and Word Test (SCWT)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
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The SCWT is extensively used to assess the ability to inhibit cognitive interference occurring when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute.
The reaction time and the amount of errors are measured during incongruent and congruent tasks (lower reaction times and less errors indicates better performance).
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baseline, 3 weeks and 13 weeks after baseline
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Changes in executive functions assessed by the Trail Making Test (TMT)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
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The TMT provides information on visual search, scanning, speed of processing, mental flexibility and executive functions using two subtasks, link numbers in increasing order and link letters and numbers in increasing order.
The reaction time and the amount of errors are measured during the subtasks (lower reaction times and less errors indicates better performance).
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baseline, 3 weeks and 13 weeks after baseline
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Changes in the Wechsler Adult Intelligence Scale (WAIS-III)
Time Frame: baseline, 3 weeks and 13 weeks after baseline
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The WAIS-III provided scores for Verbal intelligence quotient (IQ), Performance IQ, and Full Scale IQ, along with four secondary indices (Verbal Comprehension, Working Memory, Perceptual Organization, and Processing Speed).
The six Verbal Scale (Vocabulary, Similarities, Arithmetic, Digit Span, Information, and Comprehension) and five Performance Scale (Picture Completion, Digit Symbol (Coding), Block Design, Matrix Reasoning, and Picture Arrangement) subtests are combined to calculate the Full Scale IQ.
After each subtest is scored, raw point totals are converted to scaled scores according to the examinee's age range (mean= 10; standard deviation=3).
Sums of scaled scores then are computed separately for the six Verbal Scale subtests, five Performance Scale subtests, and all 11 subtests which constitute the Full Scale.
The sums are converted to deviation IQs.
The IQs generated have a mean of 100 and a standard deviation of 15 at all age levels.
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baseline, 3 weeks and 13 weeks after baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yannick Bleyenheuft, PhD, MSL-IN Lab, Institute of Neuroscience, UCLouvain
- Principal Investigator: Yves Vandermeeren, MD,PhD, Institute of Neuroscience, UCLouvain; CHU-UCL Namur, Neurology Department, UCLouvain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2020
Primary Completion (Anticipated)
November 1, 2022
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
December 2, 2020
First Submitted That Met QC Criteria
December 10, 2020
First Posted (Actual)
December 11, 2020
Study Record Updates
Last Update Posted (Actual)
June 21, 2022
Last Update Submitted That Met QC Criteria
June 16, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B403201316810h
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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