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Cerebral PalsyEarlyHABIT-ILENCT04020354

Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy

A study testing HABIT-ILE in people with Cerebral Palsy, run by Université Catholique de Louvain at 3 sites in 3 countries.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Studying in two randomized controlled trials (RCT) the changes induced by early HABIT-ILE in functional, neuroplastic and biomechanical assessment in children with unilateral and bilateral CP. Read more about this study

Who is it for?
Ages 12 to 59 months
Conditions the study is for
Cerebral Palsy
What is being tested?
HABIT-ILE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesin 3 countries
Study dates
27 Nov 2018to 30 Jun 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 12 to 59 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • children with unilateral or bilateral cerebral palsy (spastic or dyskinetic)
  • age 1 to 4 years 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 3months after the intervention time
  • severe visual impairments
  • severe cognitive impairments
  • contraindications to perform MRI assessments (Metal implants, etc.)

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Belgium1 site
  • Institute of Neuroscience, Université catholique de Louvain

    Brussels, 1200

Other trials in Belgium

France1 site
  • Fondation ILDYS - Site de Ty Yann

    Brest

Other trials in France

Italy1 site
  • IRCCS Fondazione Stella Maris

    Tirrenia, Tuscany, 56128

Other trials in Italy

About this study

Official title: Functional, Neuroplastic and Biomechanical Changes Induced by Early Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Pre-school Children With Uni- and Bilateral Cerebral Palsy

Studying in two randomized controlled trials (RCT) the changes induced by early HABIT-ILE in functional, neuroplastic and biomechanical assessment in children with unilateral and bilateral CP.

Read the detailed description

This study aims to evaluate the effect of two weeks of early Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on bimanual performance in pre-school children with unilateral cerebral palsy (CP) and on gross motor function in those with bilateral CP, compared with two weeks of usual motor activity including usual rehabilitation (control group). We will assess further changes in unilateral performance tests, daily life activities questionnaires and executive function tests. Neuroplastic changes will be assessed using brain imaging (magnetic resonance imaging, MRI) and biomechanical changes will be assessed by using optoelectronic motion capture system with electromyography (EMG), to determine the effect of HABIT-ILE on movement pattern and quality.

Conditions
Cerebral Palsy
Being tested
HABIT-ILE, Usual Care
Keywords
motor skill learning, functional changes, neuroplastic changes, biomechanical changes
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

    Early Hand and arm bimanual intensive therapy including lower extremities

  • Usual CareBehavioural

    Usual customary care

Study groups in NCT04020354
Study groupRoleWhat they receive
HABIT-ILEExperimentalEarly HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.
Receives: Behavioral: HABIT-ILE
Usual CareActive comparatorA two weeks period of usual customary care
Receives: Behavioral: Usual Care

What is being measured

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

  1. Change on Gross Motor Function (GMFM-66)

    Developed to assess the changes in gross motor function of children with cerebral palsy (scored in percentage), observed over time or after intervention for the second randomized controlled trial (RCT2)

    Measured: pre-camp, two weeks post-camp, 3 months follow-up.

  2. Change on Manual Ability (Assisting Hand Assessment (AHA))

    Developed to observe the efficacy of the assisting hand use, in children with unilateral cerebral palsy (scored in percentage), during bimanual activities for the first randomized controlled trial (RCT1)

    Measured: pre-camp, two weeks post-camp, 3 months follow-up

Secondary outcomes (26)
  1. Melbourne 2 Assessment (MA2)

    assess the unilateral performance of the upper extremities, quantifying the dexterity, fluency, accuracy and range of movement during several tasks of reaching and manipulation

    Measured: pre-camp, two weeks post-camp, 3 months follow-up

  2. Inhibitory control task

    Measures the inhibition of a motor answer. It's assessed by asking the child not to reach for a toy previously showed to play with. The maximum waiting time is 30 seconds.

    Measured: pre-camp, two weeks post-camp, 3 months follow-up

  3. Working memory task

    Measures the capacity to retain visual information in use, in a short period of time. It's assessed by hiding a toy in front of the child and asking him/her to find it from 4 possibilities.

    Measured: pre-camp, two weeks post-camp, 3 months follow-up

  4. Visuo-spatial attention assessment

    Through different simple tasks, measures the visual field, the visuo-motor coordination, the orientation of attention in the space and the eye pursuit.

    Measured: pre-camp, two weeks post-camp, 3 months follow-up

  5. Semmes-Weinstein monofilaments

    Evaluates the pressure threshold or the response to a touching sensation of the filament. It is quantified using a numerical grading ranging from high pression/clear touching sensation to a slight pression/slight touching sensation.

    Measured: pre-camp, two weeks post-camp, 3 months follow-up

  6. Pressure Threshold

    The superior pressure threshold will be determined at the moment of any visible change in the child's reaction to the pression made by the algometer.

    Measured: pre-camp, two weeks post-camp, 3 months follow-up

  7. Activlim-CP questionnaire

    This parent's filled questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or the lower extremities through 43 items specific to patients with cerebral palsy. It ranges from - 7 to +7 logits (higher score means better performance).

    Measured: pre-camp, two weeks post-camp, 3 months follow-up

  8. Pediatric Evaluation of Disability Inventory questionnaire (PEDI)

    This parent's filled questionnaire measures the performance of the child in the daily life activities and movement domains, focusing on the capacity of upper extremities and lower extremities during this activities. It ranges from 0 to 100% (higher score means better performance).

    Measured: pre-camp, two weeks post-camp, 3 months follow-up

  9. 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 (higher score means better performance).

    Measured: pre-camp, two weeks post-camp, 3 months follow-up

  10. Measure of Processes of Care (MPOC-20)

    Assesses the parents' perceptions of the care they and their children receive from children's rehabilitation treatment centres. Using a 8-point response scale, parents answer to 20 questions, indicating to what extent they have experienced the events or the situations described. A score of 7 means that they have experienced this aspect to a very great extent, or most of the time. A score of 1 means that they have not experienced this aspect at all. A score of 0 means that the question does not apply to them.

    There is no total score. However, because the statements are positively worded, higher total scores indicates that needs of the parents are being met to a great extent.

    Measured: pre-camp, two weeks post-camp, 3 months follow-up

  11. Canadian Occupational Performance Measure (COPM)

    This is an interview-setting designed to capture a patient's self-perception of performance and satisfaction of it in everyday activities, observed over time. During the 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; higher score means better performance/satisfaction)

    Measured: pre-camp, two weeks post-camp, 3 months follow-up

  12. 3D T1-weighted structural imaging (T1)

    This sequence allows to measure changes in gray matter (cortical thickness)

    Measured: pre-camp, 3 months follow-up

  13. Changes on the Fractional Anisotropy (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, 3 months follow-up

  14. Changes on the Mean Diffusivity (Diffusion tensor imaging (DTI))

    This sequence allows to measure the mean changes in the diffusivity (MD). MD is a scalar value (no unit) between zero and one that describes the degree of molecular diffusion.

    Measured: pre-camp, 3 months follow-up

  15. Changes on resting state functional connectivity (RS)

    Resting-state functional magnetic resonane imaging (rs-fMRI) evaluates the regional interactions that occur during the resting or task-negative state. The magnitud of the brain activation during rs-fMRI will be assessed

    Measured: pre-camp, 3 months follow-up

  16. Changes on 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, 3 months follow-up

  17. Changes on temporal parameters of the gait (Cycle time)

    Through a 3D motion system, we measure cycle of gait time (seconds).

    Measured: pre-camp, 3 months follow-up

  18. Changes on temporal parameters of the gait (Stance time)

    Through a 3D motion system, we measure the stance time (percentage of total gait cycle).

    Measured: pre-camp, 3 months follow-up

  19. Changes on temporal parameters of the gait (Swing time)

    Through a 3D motion system, we measure the swing time (percentage of total gait cycle).

    Measured: pre-camp, 3 months follow-up

  20. Changes on temporal parameters of the gait (Stride)

    Through a 3D motion system, we measure the gait cadence (stride per minute).

    Measured: pre-camp, 3 months follow-up

  21. Changes on temporal parameters of the gait (Velocity)

    Through a 3D motion system, we measure the gait velocity (meter/second)

    Measured: pre-camp, 3 months follow-up

  22. Changes on temporal parameters of the gait (Acceleration)

    Through a 3D motion system, we measure the gait acceleration (meters/second^2)

    Measured: pre-camp, 3 months follow-up

  23. Changes on 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, 3 months follow-up

  24. Changes on 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, 3 months follow-up

  25. Changes on 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 consist in a reaching task.

    Measured: pre-camp, 3 months follow-up

  26. 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/s^2). These measurements will be performed during therapy in 5 consecutive days for the HABIT-ILE group and during a regular week for the Usual Care group.

    Measured: 5 hours during 5 consecutive days

Timeline

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

  1. First posted16 Jul 2019
  2. Study start27 Nov 2018
  3. Primary completion31 Dec 2021
  4. Study completion30 Jun 2022 (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
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04020354
Sponsor's protocol ID
B403201316810d
Acronym
EarlyHABIT-ILE
Status last verified
May 2022
First submitted
20 Nov 2018
Last updated
25 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Araneda R, Ebner-Karestinos D, Paradis J, Klocker A, Saussez G, Demas J, Bailly R, Bouvier S, Carton de Tournai A, Herman E, Souki A, Le Gal G, Nowak E, Sizonenko SV, Newman CJ, Dinomais M, Riquelme I, Guzzetta A, Brochard S, Bleyenheuft Y. Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy: A Randomized Clinical Trial. JAMA Pediatr. 2024 Jan 1;178(1):19-28. doi: 10.1001/jamapediatrics.2023.4809.

    PubMed 37930692
  • Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y; Early HABIT-ILE group. Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial. BMC Neurol. 2020 Apr 14;20(1):133. doi: 10.1186/s12883-020-01705-4.

    PubMed 32290815

Questions about this trial

What is this clinical trial studying?

A study testing HABIT-ILE in people with Cerebral Palsy, run by Université Catholique de Louvain at 3 sites in 3 countries.

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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium, France, Italy. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change on Gross Motor Function (GMFM-66) (time frame: pre-camp, two weeks post-camp, 3 months follow-up.). The study lists 2 primary outcomes in all. 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 NCT04020354, 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 25 May 2022.

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