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| Name | Class |
|---|---|
| Fondation Paralysie Cérébrale | OTHER |
| Université Catholique de Louvain | OTHER |
| University of Pisa | OTHER |
| University of Lausanne Hospitals |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | 10 days of intensive and structured motor therapy, 5 hours a day = 50h |
|
| Control | Placebo Comparator | 10 days of care and classic activities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Other | MRI at baseline and J90 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Les Capucins | Angers | France | ||||
| Fondation ILDYS - Site de Ty Yann |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32532249 | Derived | 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. |
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All collected data that underlie results in a publication
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
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| OTHER |
| Angers University | OTHER |
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| 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 analysis | Other | 3D and EMG analysis at baseline and J90 |
|
| care and classic activities | Other | physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child. |
|
| Accelerometers | Device | During 5 days a sensor at each wrist to quantify their movement. |
|
| Brest |
| France |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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