HABIT-ILE in Infants and Toddlers With Cerebral Palsy (Baby HABIT-ILE) (Baby HABIT-ILE)

September 30, 2021 updated by: Université Catholique de Louvain

Effects of HABIT-ILE in Secondary Brain Damage Outcomes of Infants and Toddlers With Signs of Cerebral Palsy

Using a randomized controlled trial design, the possible changes induced by the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" in functional, everyday life activities and neuroplastic assessment will be studied in infants and toddlers with cerebral palsy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Using a randomized controlled trial design, the possible changes in neuroimaging, motor function and everyday life activities of infants and toddlers at risk of or with a diagnosis of cerebral palsy after participating of the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" will be studied . Changes, scored by parents in case of questionnaires and by experts in the case of tests, will be observed comparing infants/toddlers after their regular care and after receiving HABIT-ILE. Motor function and daily life activities will be correlated with neuroplastic changes. Moreover, possible therapy onset outcomes differences will be observed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children with diagnosed unilateral cerebral palsy or at risk of developing unilateral cerebral palsy or with signs of unilateral cerebral palsy
  • age 8 to 18 months inclusive (corrected age if preterm birth)
  • ability to follow instructions and complete testing according to the age.

Exclusion Criteria:

  • active seizure
  • programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 6 months after the intervention time.
  • severe visual impairments
  • severe cognitive impairments
  • contraindications to perform magnetic image resonance (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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HABIT-ILE
Baby HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks
Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)
motor learning-based, intensive therapy for children with cerebral palsy
Other Names:
  • Baby HABIT-ILE
Active Comparator: Regular care
Usual customary care intervention during two weeks
Behavioral: Regular care
customary or usual care given to any infant/toddler with cerebral palsy
Other Names:
  • Usual care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes on the Mini-Assisting Hand Assessment (Mini-AHA)
Time Frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Measures how well infants (8-18 months) with signs of unilateral or hemiplegic cerebral palsy use their more affected hand, when using both hands together to play (scored in percentage).
baseline, 3 weeks, 13 weeks and 26 weeks after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Bayley Scales of Infant and Toddler Development - Third Edition (BSID-III)
Time Frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Assess the development of infants and toddlers (1-42 months); three subitems will be considered, the Cognitive Scale, including assessments of attention (familiar and unfamiliar objects, looking for a fallen object, and pretend play), the Language Scale, including understanding and expression of language (recognition of objects and people, following directions, and naming objects and pictures), and the Motor Scale, assessing gross and fine motor skills (including grasping, sitting, stacking blocks, and climbing stairs). Raw scores of the items are converted to scale scores and composite scores (Mean 100, SD 15) ranging from 40 to 160 (higher scores indicates better performance).
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes in Gross Motor Function Measure - 66 (GMFM-66)
Time Frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Assess gross motor function of children with cerebral palsy (scored in percentage)
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes in Visuo-spatial attention assessment with the "Batterie d'évaluation du Jeune Enfant" (BAJE)
Time Frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Through different simple tasks, measures the visual field, the visuo-motor coordination, the orientation of attention in the space and the eye pursuit.
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
State of visual impairment of peripheral origin assessed with the standard Battery of Ophthalmological test for infants
Time Frame: baseline
Clinical assessment will be performed to describe the baseline of the ophthalmological condition. The ophthalmologist search for any abnormal signs of the eyes denoting the presence (or not) of visual impairments.
baseline
Changes in Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT)
Time Frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Parent's filled questionnaire measuring the performance of the child in the daily activities and mobility domains, focusing on the capacity of upper and lower extremities during these activities, computed through the PEDI-CAT software (scores reported in scaled scores).
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes in Young children's participation and environment measure (YC-PEM)
Time Frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Based in different children's activities, this parent's filled questionnaire evaluates the level of participation and the quality of the environment in which these activities take place. For each type of activity, caregivers assess 3 dimensions of the child's participation: frequency (8-point scale; 0-7), level of involvement (5-point scale; 1-5), caregiver's percent desire for change (2-points level (y/n) transformed in percentage; 0-100) and perceived impact of environmental support (3-point scale transformed in percentage; 0-100). A software calculates the total score with a maximum of 212
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes in Canadian Occupational Performance Measure (COPM)
Time Frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
In this interview, parents set up 5 activities considered difficult in daily life. These are then assessed, in a 1 to 10 scale, regarding the child'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)
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes in straightness on kinematics of the upper extremity
Time Frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Through a 3D motion system, we measure the percentage of upper extremity trajectory during a reaching task.
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes in smoothness on kinematics of the upper extremity
Time Frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Through a 3D motion system, we measure the variability of the movement during a reaching task.
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes in time of activity on kinematics of the upper extremity
Time Frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Through a 3D motion system, we measure the time from onset to end of the task (in seconds) during a reaching task.
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes in the quantification of physical activity
Time Frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
With a movement sensor on each wrist, the percentage of total time spent in movement (i.e. crawling, walking and running) is measured. Calculated in terms of the changes in the acceleration (m/s2).
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes in cortical thickness of the brain's gray matter
Time Frame: baseline, 3 weeks, 13 weeks and 26 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.
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes in Fractional Anisotropy (FA) of the corticospinal tract from the motor cortex to the cerebellar peduncle
Time Frame: baseline, 3 weeks, 13 weeks and 26 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, 13 weeks and 26 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, 13 weeks and 26 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, 13 weeks and 26 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, 13 weeks and 26 weeks after baseline
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.
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes of the fraction and heterogeneity in the neural fibers or isotropic compartments of the corticospinal tract from the motor cortex to the cerebellar peduncle using the DIAMOND model
Time Frame: baseline, 3 weeks, 13 weeks and 26 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 ("frac", ranging from 0 to 1, no unit) and heterogeneity ("HEI", ranging from 0 to 1, no unit) of each compartment can be estimated. These metrics 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.
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes in resting-state functional connectivity
Time Frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
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
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Changes in brain white matter microstructure (WM-μs) using the Microstructure Fingerprinting model
Time Frame: baseline, 3 weeks, 13 weeks and 26 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.
baseline, 3 weeks, 13 weeks and 26 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université Catholique de Louvain

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital of Mont-Godinne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B403201316810g

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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