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Cerebral PalsyBaby HABIT-ILENCT04698395

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

A study testing Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Regular care in people with Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 18 months
Conditions the study is for
Cerebral Palsy
What is being tested?
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Regular care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteBelgium
Study dates
15 Feb 2021to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 18 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

Yannick Bleyenheuft, PhD contact

+3227645446

yannick.bleyenheuft@uclouvain.be

Daniela Ebner, PhD contact

+3227645446

daniela.ebner@uclouvain.be

Belgium1 site, 1 recruiting
  • Institute of Neuroscience, Université catholique de Louvain

    Brussels, 1200

    Yannick Bleyenheuft, Pr, +3227645446, yannick.bleyenheuft@uclouvain.be

    Daniela Ebner, PhD, +3227645446, daniela.ebner@uclouvain.be

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Conditions
Cerebral Palsy
Being tested
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), Regular care
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)Behavioural

    Also called Baby HABIT-ILE

    motor learning-based, intensive therapy for children with cerebral palsy

  • Regular careBehavioural

    Also called Usual care

    customary or usual care given to any infant/toddler with cerebral palsy

Study groups in NCT04698395
Study groupRoleWhat they receive
HABIT-ILEExperimentalBaby HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks
Receives: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)
Regular careActive comparatorUsual customary care intervention during two weeks
Receives: Behavioral: Regular care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

Secondary outcomes (18)
  1. 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).

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  2. Changes in Gross Motor Function Measure - 66 (GMFM-66)

    Assess gross motor function of children with cerebral palsy (scored in percentage)

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  3. 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.

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  4. 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.

    Measured: baseline

  5. 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).

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  6. 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

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  7. 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)

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  8. 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.

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  9. 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.

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  10. 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.

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  11. 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).

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  12. 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.

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  13. 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.

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  14. 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.

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  15. 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.

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  16. 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.

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  17. 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

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

  18. 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.

    Measured: baseline, 3 weeks, 13 weeks and 26 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2021
  2. Study start15 Feb 2021
  3. Primary completionAug 2022 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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
Model description
Allocation
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04698395
Sponsor's protocol ID
B403201316810g
Acronym
Baby HABIT-ILE
Status last verified
Sep 2021
First submitted
2 Dec 2020
Last updated
1 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carton de Tournai A, Herman E, Ebner-Karestinos D, Gathy E, Araneda R, Renders A, De Clerck C, Kilcioglu S, Dricot L, Macq B, Vandermeeren Y, Bleyenheuft Y. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Infants With Unilateral Cerebral Palsy: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2445133. doi: 10.1001/jamanetworkopen.2024.45133.

    PubMed 39556397
  • Carton de Tournai A, Herman E, Gathy E, Ebner-Karestinos D, Araneda R, Dricot L, Macq B, Vandermeeren Y, Bleyenheuft Y. Baby HABIT-ILE intervention: study protocol of a randomised controlled trial in infants aged 6-18 months with unilateral cerebral palsy. BMJ Open. 2024 Feb 17;14(2):e078383. doi: 10.1136/bmjopen-2023-078383.

    PubMed 38367973

Questions about this trial

What is this clinical trial studying?

A study testing Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Regular care 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 3 inclusion and 5 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 1 Oct 2021. 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, PhD (+3227645446, 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 on the Mini-Assisting Hand Assessment (Mini-AHA) (time frame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04698395, which also lists 2 linked publications.

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 1 Oct 2021.

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