Cerebral Palsy
Conditions
Keywords
Cerebral Palsy (CP), pre-school children with unilateral and bilateral CP
Brief 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 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).
Interventions
OTHERMRI
MRI at baseline and J90
OTHERElectro-Encephalography-High Density (children with unilateral PC only)
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
OTHER3D and EMG analysis
3D and EMG analysis at baseline and J90
physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.
DEVICEAccelerometers
During 5 days a sensor at each wrist to quantify their movement.
Sponsors
Fondation Paralysie Cérébrale
Université Catholique de Louvain
University of Pisa
University of Lausanne Hospitals
University Angers
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only) | 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) | 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. |
Countries
France
Outcome results
None listed