NCT04362800

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 12 Months – 59 Months
• Healthy volunteers: Not accepted

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 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).

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
OTHER	MRI	MRI at baseline and J90
OTHER	Electro-Encephalography-High Density	Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
OTHER	3D and EMG analysis	3D and EMG analysis at baseline and J90
OTHER	care and classic activities	physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.

Timeline

• Start date: 2021-01-19
• Primary completion: 2021-09-17
• Completion: 2021-09-17
• First posted: 2020-04-27
• Last updated: 2021-12-21

Locations

2 sites across 1 country: France