Effect of HABIT-ILE on the Body Function and Structures of Children With Cerebral Palsy

Université Catholique de Louvain

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Behavioral: Conventional intervention; Behavioral: HABIT-ILE

Study type: Interventional

Funder types: Other

Identifiers

NCT04403490

B403201316810f

Details and patient eligibility

About

There is strong evidence that recent intensive interventions based on motor skill learning principles are efficient on functional and neuroplastic changes of children with cerebral palsy (CP).

Besides, impaired selective voluntary motor control (SVMC) is one of four interrelated neuromuscular deficits in children with CP and is listed in the ICF-CY (International Classification of Functioning, Disability and Health for Children and Youth) under body functions. Additionally, impaired SVMC has been shown to negatively affect the motor and functional abilities of children with CP. However, there have been little scientific investigations on the trainability of SVMC according to therapeutic interventions.

Therefore, the study aims to evaluate the effect of Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on the body function and structures of children with bilateral and unilateral cerebral palsy, including SVMC and brain structure.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed bilateral and unilateral cerebral palsy,
• MACS levels from I to IV,
• GMFCS levels from I to IV,
• Ability to follow instructions and complete testing.

Exclusion criteria

• Orthopedic surgery, botulinum toxin injections or another unusual intervention less than 6 months before or within the study period.
• Unstable seizure
• Severe visual or cognitive impairments likely to interfere with intervention or testing session completion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

HABIT-ILE

Experimental group

Description:

Hand and arm bimanual intensive therapy including lower extremities

Treatment:

Behavioral: HABIT-ILE

Conventional intervention

Active Comparator group

Description:

Conventional physical and occupational therapy

Treatment:

Behavioral: Conventional intervention