Cerebral PalsyHABIT-ILENCT04017871
Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy
A study testing MRI, Electro-Encephalography-High Density (children with unilateral PC only) and 3D and EMG analysis in people with Cerebral Palsy, run by University Hospital, Brest at 2 sites in France.
Trial summary
An urgent priority in the field of paediatric neurorehabilitation is the development of effective early motor interventions. Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (= HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the Upper Extremities (UE) and Lower… 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 (children with unilateral PC only) and 3D and EMG analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Aug 2019to 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 unilateral cerebral palsy or Child with bilateral cerebral palsy proven spastic or dyskinetic
- Aged from 1 to 4 years old (12 to 59 months) (age corrected if prematurity) able to follow instructions and to be able to carry out all the evaluations, according to his age
Who cannot join
- Age> 2 years old (35 months) or 4 years old (59 months) during the internship evaluation period
- Uncontrolled epilepsy
- History of botulinum toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period)
- Visual or cognitive impairment that may interfere with the management
- Common contraindications to magnetic resonance imaging (MRI) such as metal implants
Trial locations and contacts
2 sites in 1 country.
About this study
An urgent priority in the field of paediatric neurorehabilitation is the development of effective early motor interventions.
Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (= HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the Upper Extremities (UE) and Lower Extremities (LE) and has been shown to improve aspects of motor function of the UE and LE in school age children with unilateral and bilateral Cerebral Palsy (CP) across the 3 levels of the International Classification of Functioning, Disability and Health (ICFDH). The principles and content of HABIT-ILE can be applied to pre-school children and this method is highly promising for early rehabilitation.
Read the detailed description
The primary objective of this study is to evaluate the effect of two weeks of early HABIT-ILE on gross motor function in pre-school children with unilateral and and bilateral Cerebral Paralysy (CP), in comparison with two weeks of usual motor activity including usual rehabilitation (control group).
- Conditions
- Cerebral Palsy
- Being tested
- MRI, Electro-Encephalography-High Density (children with unilateral PC only), 3D and EMG analysis, care and classic activities, Accelerometers
- Keywords
- Cerebral Palsy (CP), pre-school children with unilateral and 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 Density (children with unilateral PC only)Other
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.
AccelerometersDevice
During 5 days a sensor at each wrist to quantify their movement.
| 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 (children with unilateral PC only); Other: 3D and EMG analysis; Other: care and classic activities; Device: Accelerometers |
| Control | Placebo comparator | 10 days of care and classic activities Receives: Other: MRI; Other: Electro-Encephalography-High Density (children with unilateral PC only); Other: 3D and EMG analysis; Other: care and classic activities; Device: Accelerometers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only)
measures and describes how children with upper limb disability in one hand use his/her affected hand collaboratively with the non affected hand in bimanual play.The score range from 0 to 100 as a percentage. 100 is the best outcome.
Measured: 1 hour
Gross Motor Function Measure (GMFM) (for bilateral CP only)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start18 Aug 2019
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Paralysie Cérébrale, Université Catholique de Louvain, University of Pisa, University of Lausanne Hospitals, Angers University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017871
- Sponsor's protocol ID
- EARLY_HABIT-ILE (29BRC19.0050)
- Acronym
- HABIT-ILE
- Status last verified
- Dec 2021
- First submitted
- 10 May 2019
- Last updated
- 7 Dec 2021
- 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
Publications
Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Ebner-Karestinos D, Paradis J, Klocker A, Saussez G, Demas J, Bailly R, Bouvier S, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y. Protocol of changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial. BMC Neurol. 2020 Jun 12;20(1):243. doi: 10.1186/s12883-020-01820-2.
PubMed 32532249
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04017871
- Acronym / sponsor ID
- HABIT-ILE / EARLY_HABIT-ILE (29BRC19.0050)
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy (CP), pre-school children with unilateral and bilateral CP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Fondation Paralysie Cérébrale, Université Catholique de Louvain, University of Pisa, University of Lausanne Hospitals, Angers University
- Study start
- 18 Aug 2019 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 12 Jul 2019 (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.
An urgent priority in the field of paediatric neurorehabilitation is the development of effective early motor interventions.
Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (= HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the Upper Extremities (UE) and Lower Extremities (LE) and has been shown to improve aspects of motor function of the UE and LE in school age children with unilateral and bilateral Cerebral Palsy (CP) across the 3 levels of the International Classification of Functioning, Disability and Health (ICFDH). The principles and content of HABIT-ILE can be applied to pre-school children and this method is highly promising for early rehabilitation.
Detailed description
The primary objective of this study is to evaluate the effect of two weeks of early HABIT-ILE on gross motor function in pre-school children with unilateral and and bilateral Cerebral Paralysy (CP), in comparison with two weeks of usual 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 (children with unilateral PC only), Other: 3D and EMG analysis, Other: care and classic activities, Device: Accelerometers10 days of intensive and structured motor therapy, 5 hours a day = 50h |
| Control | Placebo comparator | Other: MRI, Other: Electro-Encephalography-High Density (children with unilateral PC only), Other: 3D and EMG analysis, Other: care and classic activities, Device: Accelerometers10 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 (2 listed)
- Child with unilateral cerebral palsy or Child with bilateral cerebral palsy proven spastic or dyskinetic
- Aged from 1 to 4 years old (12 to 59 months) (age corrected if prematurity) able to follow instructions and to be able to carry out all the evaluations, according to his age
Key exclusion criteria (5 listed)
- Age> 2 years old (35 months) or 4 years old (59 months) during the internship evaluation period
- Uncontrolled epilepsy
- History of botulinum toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period)
- Visual or cognitive impairment that may interfere with the management
- Common 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 Density (children with unilateral PC only)Electro-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 |
| AccelerometersDuring 5 days a sensor at each wrist to quantify their movement. | Device | Control, Interventional |
Primary outcome
Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only)
Time frame: 1 hour
measures and describes how children with upper limb disability in one hand use his/her affected hand collaboratively with the non affected hand in bimanual play.The score range from 0 to 100 as a percentage. 100 is the best outcome.
Gross Motor Function Measure (GMFM) (for bilateral CP only)
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.
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 Dec 2021.
- Derived from this study: PubMed 32532249Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Ebner-Karestinos D, Paradis J, Klocker A, Saussez G, Demas J, Bailly R, Bouvier S, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y. Protocol of changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial. BMC Neurol. 2020 Jun 12;20(1):243. doi: 10.1186/s12883-020-01820-2.
- 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 (children with unilateral PC only) 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 2 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 Dec 2021. 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?
Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only) (time frame: 1 hour). 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 NCT04017871, which also lists 1 linked publication.
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 Dec 2021.