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

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)
Regular care
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

8 Months - 18 Months (Child)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Institute of Neuroscience, Université catholique de LouvainRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HABIT-ILE

Regular care

Arm Description

Baby HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks

Usual customary care intervention during two weeks

Outcomes

Primary Outcome Measures

Changes on the Mini-Assisting Hand Assessment (Mini-AHA)
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).

Secondary Outcome Measures

Changes in Bayley Scales of Infant and Toddler Development - Third Edition (BSID-III)
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).
Changes in Gross Motor Function Measure - 66 (GMFM-66)
Assess gross motor function of children with cerebral palsy (scored in percentage)
Changes in Visuo-spatial attention assessment with the "Batterie d'évaluation du Jeune Enfant" (BAJE)
Through different simple tasks, measures the visual field, the visuo-motor coordination, the orientation of attention in the space and the eye pursuit.
State of visual impairment of peripheral origin assessed with the standard Battery of Ophthalmological test for infants
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.
Changes in Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT)
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).
Changes in Young children's participation and environment measure (YC-PEM)
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
Changes in Canadian Occupational Performance Measure (COPM)
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)
Changes in straightness on kinematics of the upper extremity
Through a 3D motion system, we measure the percentage of upper extremity trajectory during a reaching task.
Changes in smoothness on kinematics of the upper extremity
Through a 3D motion system, we measure the variability of the movement during a reaching task.
Changes in time of activity on kinematics of the upper extremity
Through a 3D motion system, we measure the time from onset to end of the task (in seconds) during a reaching task.
Changes in the quantification of physical activity
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).
Changes in cortical thickness of the brain's gray matter
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.
Changes in Fractional Anisotropy (FA) of the corticospinal tract from the motor cortex to the cerebellar peduncle
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.
Changes on the Axial, Radial and Mean Diffusivity (AD, RD, MD) of the corticospinal tract from the motor cortex to the cerebellar peduncle
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.
Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the NODDI model
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.
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
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.
Changes in resting-state functional connectivity
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
Changes in brain white matter microstructure (WM-μs) using the Microstructure Fingerprinting model
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.

Full Information

First Posted
December 2, 2020
Last Updated
September 30, 2021
Sponsor
Université Catholique de Louvain
Collaborators
University Hospital of Mont-Godinne
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1. Study Identification

Unique Protocol Identification Number
NCT04698395
Brief Title
HABIT-ILE in Infants and Toddlers With Cerebral Palsy (Baby HABIT-ILE)
Acronym
Baby HABIT-ILE
Official Title
Effects of HABIT-ILE in Secondary Brain Damage Outcomes of Infants and Toddlers With Signs of Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
Collaborators
University Hospital of Mont-Godinne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Allocation
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HABIT-ILE
Arm Type
Experimental
Arm Description
Baby HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks
Arm Title
Regular care
Arm Type
Active Comparator
Arm Description
Usual customary care intervention during two weeks
Intervention Type
Behavioral
Intervention Name(s)
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)
Other Intervention Name(s)
Baby HABIT-ILE
Intervention Description
motor learning-based, intensive therapy for children with cerebral palsy
Intervention Type
Behavioral
Intervention Name(s)
Regular care
Other Intervention Name(s)
Usual care
Intervention Description
customary or usual care given to any infant/toddler with cerebral palsy
Primary Outcome Measure Information:
Title
Changes on the Mini-Assisting Hand Assessment (Mini-AHA)
Description
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).
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Secondary Outcome Measure Information:
Title
Changes in Bayley Scales of Infant and Toddler Development - Third Edition (BSID-III)
Description
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).
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes in Gross Motor Function Measure - 66 (GMFM-66)
Description
Assess gross motor function of children with cerebral palsy (scored in percentage)
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes in Visuo-spatial attention assessment with the "Batterie d'évaluation du Jeune Enfant" (BAJE)
Description
Through different simple tasks, measures the visual field, the visuo-motor coordination, the orientation of attention in the space and the eye pursuit.
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
State of visual impairment of peripheral origin assessed with the standard Battery of Ophthalmological test for infants
Description
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.
Time Frame
baseline
Title
Changes in Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT)
Description
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).
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes in Young children's participation and environment measure (YC-PEM)
Description
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
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes in Canadian Occupational Performance Measure (COPM)
Description
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)
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes in straightness on kinematics of the upper extremity
Description
Through a 3D motion system, we measure the percentage of upper extremity trajectory during a reaching task.
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes in smoothness on kinematics of the upper extremity
Description
Through a 3D motion system, we measure the variability of the movement during a reaching task.
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes in time of activity on kinematics of the upper extremity
Description
Through a 3D motion system, we measure the time from onset to end of the task (in seconds) during a reaching task.
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes in the quantification of physical activity
Description
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).
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes in cortical thickness of the brain's gray matter
Description
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.
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes in Fractional Anisotropy (FA) of the corticospinal tract from the motor cortex to the cerebellar peduncle
Description
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.
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes on the Axial, Radial and Mean Diffusivity (AD, RD, MD) of the corticospinal tract from the motor cortex to the cerebellar peduncle
Description
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.
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the NODDI model
Description
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.
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
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
Description
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.
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes in resting-state functional connectivity
Description
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
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Title
Changes in brain white matter microstructure (WM-μs) using the Microstructure Fingerprinting model
Description
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.
Time Frame
baseline, 3 weeks, 13 weeks and 26 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yannick Bleyenheuft, PhD
Phone
+3227645446
Email
yannick.bleyenheuft@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Ebner, PhD
Phone
+3227645446
Email
daniela.ebner@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannick Bleyenheuft, PhD
Organizational Affiliation
MSL-IN Lab, Institute of Neuroscience, UCLouvain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yves Vandermeeren, MD, PhD
Organizational Affiliation
Institute of Neuroscience, UCLouvain; CHU-UCL Namur, Neurology Department, UCLouvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Neuroscience, Université catholique de Louvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannick Bleyenheuft, Pr
Phone
+3227645446
Email
yannick.bleyenheuft@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Daniela Ebner, PhD
Phone
+3227645446
Email
daniela.ebner@uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://uclouvain.be/en/research-institutes/ions/cosy/motor-skill-learning-and-intensive-neurorehabilitation-lab-msl-in.html
Description
University's lab web page (english)

Learn more about this trial

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

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