Cerebral PalsyMOOVNCT04362800
Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive Motrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy
A study testing MRI, Electro-Encephalography-High Density and 3D and EMG analysis in people with Cerebral Palsy, run by University Hospital, Brest at 2 sites in France.
Trial summary
One of the urgent priorities in the field of pediatric neuro-rehabilitation is the development of efficient early motor interventions for children with cerebral palsy (CP). Animal studies suggest that early intensive interventions are likely to have a significant impact on the organization of the brain and… 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?
- MRI, Electro-Encephalography-High Density and 3D and EMG analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Jan 2021to 17 Sep 2021
- 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
- Child with bilateral cerebral palsy proven to be spastic or dyskinetic
- 1 to 4 years old inclusive (12 to 59 months) (age corrected if premature) able to follow instructions and to be able to carry out all the assessments, in accordance with his age
- Being matched to a child according to age, etiology of CP / classification of motor function (GMFCS)
- Signature of consent by the two holders of parental authority
Who cannot join
- Exceed 4 years and 11 months (59 months) during the internship evaluation period.
- Uncontrolled epilepsy.
- History of toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period).
- Visual or cognitive deficit preventing the child from seeing the games and interacting
- Usual contraindications to magnetic resonance imaging (MRI) such as metal implants.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Les Capucins
Angers, Angers, 49000
Fondation ILDYS - Site de Ty Yann
Brest, Brest, 29000
About this study
Official title: Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive MOtrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy: a Trial Multicentre Randomized Control With Medico-economic Evaluation
One of the urgent priorities in the field of pediatric neuro-rehabilitation is the development of efficient early motor interventions for children with cerebral palsy (CP). Animal studies suggest that early intensive interventions are likely to have a significant impact on the organization of the brain and corticospinal tracts, reducing motor impairments and their medium and long-term consequences in children with cerebral palsy. Although most of the growth, development and cortical organization takes place in the time course of the first 2 years of life, most studies investigating the effectiveness of intensive rehabilitation and associated neurophysiological mechanisms have been conducted in school-aged children (> 6 years). In addition, the vast majority of these studies were conducted in children with unilateral CP, while the bilateral form of the pathology has the highest prevalence. It is therefore a priority to investigate the effectiveness of early interventions on the overall motor function of children with CP, especially in children with bilateral form of CP.
Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) makes it possible to apply the concepts of structured motor learning and intensive treatment to both the upper limbs and the lower limbs and demonstrated improvements at both levels in school-aged children with unilateral CP and bilateral and then at all three International Classification of Functioning and Disability levels. The principles and content of HABIT-ILE can be applied to pre-school children and this method is promising for early neuro-rehabilitation.
Read the detailed description
The main objective of this study is to evaluate the effect of 10 days (i.e. 50 hours) of early HABIT-ILE (HABIT-ILE) on the overall motor function of children aged 1 to 4 with bilateral cerebral palsy in comparison to 10 days (50h) of spontaneous overall motor activity including usual rehabilitation (control group).
- Conditions
- Cerebral Palsy
- Being tested
- MRI, Electro-Encephalography-High Density, 3D and EMG analysis, care and classic activities
- Keywords
- cerebral palsy (CP), pre-school children with bilateral CP
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
MRI at baseline and J90
Electro-Encephalography-High DensityOther
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
3D and EMG analysisOther
3D and EMG analysis at baseline and J90
care and classic activitiesOther
physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | 10 days of intensive and structured motor therapy, 5 hours a day = 50h Receives: Other: MRI; Other: Electro-Encephalography-High Density; Other: 3D and EMG analysis; Other: care and classic activities |
| Control | Placebo comparator | 10 days of care and classic activities Receives: Other: MRI; Other: Electro-Encephalography-High Density; Other: 3D and EMG analysis; Other: care and classic activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure (GMFM)
Measures change in gross motor function over time in children with cerebral palsy. The score range from 0 to 100 as a percentage. 100 is the best outcome.
Measured: 1 hour
Secondary outcomes (8)
Both Hands Assessment
Assess the extent to which the more severely affected hand can assist during two-handed activities
Measured: up to 90 days
Melbourne Assessment 2
Assess the quality of movement in children with neurological disorders
Measured: up to 90 days
ACTIVLIM-CP
Assess the child's overall performance during daily activities.
Measured: up to 90 days
Young Children's Participation and Environment Measure
Assess the participation of young children with disabilities and delays in terms of patterns of participation at home, in daycare/preschool, and in the community; perceived environmental supports and barriers to participation; and activity-specific parenting strategies to promote participation
Measured: up to 90 days
Pediatric Evaluation of Disability Inventory Computer Adaptive Test
assess functional abilities in four areas: activities of daily living, mobility, social/cognitive functioning, and self-care.
Measured: up to 90 days
Canadian Occupational Performance Measure
define therapeutic goals and measure the child's progress and the parents' level of satisfaction for each functional goal.
Measured: up to 90 days
Visual-spatial functions
Assessment of tracking ability, visual field exploration, and oculomotor coordination using the assessment kit developed by Prof. Chokron of the Adolphe de Rothschild Ophthalmological Foundation in Paris, France
Measured: up to 90 days
Healthcare Economic Analysis
to demonstrate the effectiveness of early intensive rehabilitation compared to traditional care through a cost-effectiveness study
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start19 Jan 2021
- Primary completion17 Sep 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362800
- Sponsor's protocol ID
- MOOV (29BRC20.0046)
- Acronym
- MOOV
- Status last verified
- May 2026
- First submitted
- 23 Apr 2020
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive MOtrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy: a Trial Multicentre Randomized Control With Medico-economic Evaluation
- ClinicalTrials.gov ID
- NCT04362800
- Acronym / sponsor ID
- MOOV / MOOV (29BRC20.0046)
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy (CP), pre-school children with bilateral CP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the urgent priorities in the field of pediatric neuro-rehabilitation is the development of efficient early motor interventions for children with cerebral palsy (CP). Animal studies suggest that early intensive interventions are likely to have a significant impact on the organization of the brain and corticospinal tracts, reducing motor impairments and their medium and long-term consequences in children with cerebral palsy. Although most of the growth, development and cortical organization takes place in the time course of the first 2 years of life, most studies investigating the effectiveness of intensive rehabilitation and associated neurophysiological mechanisms have been conducted in school-aged children (> 6 years). In addition, the vast majority of these studies were conducted in children with unilateral CP, while the bilateral form of the pathology has the highest prevalence. It is therefore a priority to investigate the effectiveness of early interventions on the overall motor function of children with CP, especially in children with bilateral form of CP.
Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) makes it possible to apply the concepts of structured motor learning and intensive treatment to both the upper limbs and the lower limbs and demonstrated improvements at both levels in school-aged children with unilateral CP and bilateral and then at all three International Classification of Functioning and Disability levels. The principles and content of HABIT-ILE can be applied to pre-school children and this method is promising for early neuro-rehabilitation.
Detailed description
The main objective of this study is to evaluate the effect of 10 days (i.e. 50 hours) of early HABIT-ILE (HABIT-ILE) on the overall motor function of children aged 1 to 4 with bilateral cerebral palsy in comparison to 10 days (50h) of spontaneous overall motor activity including usual rehabilitation (control group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: MRI, Other: Electro-Encephalography-High Density, Other: 3D and EMG analysis, Other: care and classic activities10 days of intensive and structured motor therapy, 5 hours a day = 50h |
| Control | Placebo comparator | Other: MRI, Other: Electro-Encephalography-High Density, Other: 3D and EMG analysis, Other: care and classic activities10 days of care and classic activities |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child with bilateral cerebral palsy proven to be spastic or dyskinetic
- 1 to 4 years old inclusive (12 to 59 months) (age corrected if premature) able to follow instructions and to be able to carry out all the assessments, in accordance with his age
- Being matched to a child according to age, etiology of CP / classification of motor function (GMFCS)
- Signature of consent by the two holders of parental authority
Key exclusion criteria (5 listed)
- Exceed 4 years and 11 months (59 months) during the internship evaluation period.
- Uncontrolled epilepsy.
- History of toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period).
- Visual or cognitive deficit preventing the child from seeing the games and interacting
- Usual contraindications to magnetic resonance imaging (MRI) such as metal implants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI at baseline and J90 | Other | Control, Interventional |
| Electro-Encephalography-High DensityElectro-Encephalography-High Density (children with unilateral PC only) at baseline and J90 | Other | Control, Interventional |
| 3D and EMG analysis3D and EMG analysis at baseline and J90 | Other | Control, Interventional |
| care and classic activitiesphysiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child. | Other | Control, Interventional |
Primary outcome
Gross Motor Function Measure (GMFM)
Time frame: 1 hour
Measures change in gross motor function over time in children with cerebral palsy. The score range from 0 to 100 as a percentage. 100 is the best outcome.
8 secondary outcomes
Both Hands Assessment
Time frame: up to 90 days
Melbourne Assessment 2
Time frame: up to 90 days
ACTIVLIM-CP
Time frame: up to 90 days
Young Children's Participation and Environment Measure
Time frame: up to 90 days
Pediatric Evaluation of Disability Inventory Computer Adaptive Test
Time frame: up to 90 days
Canadian Occupational Performance Measure
Time frame: up to 90 days
Visual-spatial functions
Time frame: up to 90 days
Healthcare Economic Analysis
Time frame: through study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, Electro-Encephalography-High Density and 3D and EMG analysis in people with Cerebral Palsy, run by University Hospital, Brest at 2 sites in France.
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 4 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: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gross Motor Function Measure (GMFM) (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.