NCT04017871

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 12 Months – 59 Months
• Healthy volunteers: Not accepted

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).

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
OTHER	MRI	MRI at baseline and J90
OTHER	Electro-Encephalography-High Density (children with unilateral PC only)	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.
DEVICE	Accelerometers	During 5 days a sensor at each wrist to quantify their movement.

Timeline

• Start date: 2019-08-18
• Primary completion: 2021-09-17
• Completion: 2021-09-17
• First posted: 2019-07-12
• Last updated: 2021-12-07

Locations

2 sites across 1 country: France