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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: care and classic activities; Other: 3D and EMG analysis; Device: Accelerometers; Other: Electro-Encephalography-High Density (children with unilateral PC only); Other: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT04017871

EARLY_HABIT-ILE (29BRC19.0050)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 42 patients

Sex: All

Ages: 12 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups, including a placebo group

Interventional

Experimental group

Description:

10 days of intensive and structured motor therapy, 5 hours a day = 50h

Treatment:

Device: Accelerometers

Other: Electro-Encephalography-High Density (children with unilateral PC only)

Other: care and classic activities

Other: 3D and EMG analysis

Other: MRI

Control

Placebo Comparator group

Description:

10 days of care and classic activities

Treatment:

Device: Accelerometers

Other: Electro-Encephalography-High Density (children with unilateral PC only)

Other: care and classic activities

Other: 3D and EMG analysis

Other: MRI