Parent-delivered HABIT-ILE in Young Children With Cerebral Palsy in Vietnam

Université Catholique de Louvain

Status: Not yet enrolling

Conditions: Cerebral Palsy

Treatments: Behavioral: Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts.; Behavioral: Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at home with the online guidance and supervision of experts.

Study type: Interventional

Funder types: Other

Identifiers

NCT06593158

Parent-delivered HABIT-ILE

Details and patient eligibility

About

This study will use a randomized controlled trial design with a longitudinal baseline to assess the effectiveness of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on motor function and the ability to perform daily activities in Vietnamese children with cerebral palsy, specifically through a caregiver-delivered approach. Participants will be randomly assigned to one of two groups: HABIT-ILE at Camp with Caregivers and HABIT-ILE at Home with Caregivers. The study aims to determine whether a caregiver-delivered intervention will be effective compared to the "no intensive" phase and whether on-site intervention with the constant presence of supervisors may have additional effects.

Full description

Cerebral palsy (CP) is a group of non-progressive early onset neuromotor disorders that affect the developing brain of the fetus or infant. Motor disorders in CP are often accompanied by sensory, perceptual, cognitive, communicative, and behavioural disorders, and secondary musculoskeletal problems. CP is characterized by impairment in gross motor function involving large muscles which perform daily activities such as walking, standing, running, jumping and fine motor function involving small muscles in the hand and wrist which perform flexible hand and finger grip activities, communication ability. The purpose of rehabilitation in children with CP is to minimize the impact of physical disability, to improve independence in the community and to improve the quality of life of children and their families.

Traditionally, CP was managed through neurorehabilitation based on neurodevelopmental methods. However, the effectiveness of these methods is still being hotly debated. In contrast, there is evidence that intensive therapy based on motor skill learning is more effective in creating functional and neuroplastic changes. Intensive therapy is a high-intensity program completed daily for several weeks, focusing on repetitive tasks with gradually increasing difficulty towards functional goals identified by the child and the child's caregiver. Hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) has shown improvement in motor and functional outcomes in children with CP. HABIT-ILE therapy is recommended in high-income countries (HIC) in the form of camps where children practice continuously for a short period (2 weeks), totalling 50-90 hours in a treatment session with therapists. In Vietnam, rehabilitation is not widely accessible, possibly due to high treatment costs and a lack of treatment facilities and staff. Recognizing the potential of HABIT-ILE therapy and the practical context of Vietnam, in this study, we aim to apply Parent-delivered HABIT-ILE and explore the effectiveness of this therapy on children with CP in Vietnam.

Enrollment: 48 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis: Cerebral palsy
• Type of Cerebral palsy: Bilateral cerebral palsy
• Level of gross motor function: level II to IV of GMFCS E& R
• Level of manual ability: level I to IV of mini- MACS
• Environmental factors: Having caregiver support during the study (availability of a caregiver for 5h per day during two weeks of therapy)
• Age of children: 2 to 6 years old

Exclusion criteria

• The child has uncontrolled seizures.
• The child has visual impairment that could interfere with the assessment and treatment.
• The child has severe cognitive problems, unable to understand or be interested in simple games
• Other intensive therapy or surgery/medical intervention that could interfere with study results in the past 6 months and during the study period (e.g. botulinum toxin, etc).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

HABIT-ILE at Camp with Caregivers

Active Comparator group

Treatment:

Behavioral: Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts.

HABIT-ILE at Home with Caregivers

Active Comparator group

Treatment:

Behavioral: Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at home with the online guidance and supervision of experts.