HABIT-ILE in Infants and Toddlers With Cerebral Palsy (Baby HABIT-ILE)

Université Catholique de Louvain

Status: Unknown

Conditions: Cerebral Palsy

Treatments: Behavioral: Regular care; Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)

Study type: Interventional

Funder types: Other

Identifiers

NCT04698395

B403201316810g

Details and patient eligibility

About

Using a randomized controlled trial design, the possible changes induced by the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" in functional, everyday life activities and neuroplastic assessment will be studied in infants and toddlers with cerebral palsy.

Full description

Using a randomized controlled trial design, the possible changes in neuroimaging, motor function and everyday life activities of infants and toddlers at risk of or with a diagnosis of cerebral palsy after participating of the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" will be studied . Changes, scored by parents in case of questionnaires and by experts in the case of tests, will be observed comparing infants/toddlers after their regular care and after receiving HABIT-ILE. Motor function and daily life activities will be correlated with neuroplastic changes. Moreover, possible therapy onset outcomes differences will be observed.

Enrollment: 48 estimated patients

Sex: All

Ages: 8 to 18 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children with diagnosed unilateral cerebral palsy or at risk of developing unilateral cerebral palsy or with signs of unilateral cerebral palsy
• age 8 to 18 months 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 6 months after the intervention time.
• severe visual impairments
• severe cognitive impairments
• contraindications to perform magnetic image resonance (MRI) assessments (metal implants, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

HABIT-ILE

Experimental group

Description:

Baby HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks

Treatment:

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)

Regular care

Active Comparator group

Description:

Usual customary care intervention during two weeks

Treatment:

Behavioral: Regular care