Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy (EarlyHABIT-ILE)

Université Catholique de Louvain

Status: Unknown

Conditions: Cerebral Palsy

Treatments: Behavioral: HABIT-ILE; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04020354

B403201316810d

Details and patient eligibility

About

Studying in two randomized controlled trials (RCT) the changes induced by early HABIT-ILE in functional, neuroplastic and biomechanical assessment in children with unilateral and bilateral CP.

Full description

This study aims to evaluate the effect of two weeks of early Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on bimanual performance in pre-school children with unilateral cerebral palsy (CP) and on gross motor function in those with bilateral CP, compared with two weeks of usual motor activity including usual rehabilitation (control group). We will assess further changes in unilateral performance tests, daily life activities questionnaires and executive function tests. Neuroplastic changes will be assessed using brain imaging (magnetic resonance imaging, MRI) and biomechanical changes will be assessed by using optoelectronic motion capture system with electromyography (EMG), to determine the effect of HABIT-ILE on movement pattern and quality.

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children with unilateral or bilateral cerebral palsy (spastic or dyskinetic)
• age 1 to 4 years inclusive (corrected age if preterm birth)
• ability to follow instructions and complete testing according to the age.

Exclusion criteria

• active seizure
• programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time
• severe visual impairments
• severe cognitive impairments
• contraindications to perform MRI assessments (Metal implants, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

HABIT-ILE

Experimental group

Description:

Early HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.

Treatment:

Behavioral: HABIT-ILE

Usual Care

Active Comparator group

Description:

A two weeks period of usual customary care

Treatment:

Behavioral: Usual Care