Clinical trial NCT06593158: Parent-delivered HABIT-ILE in Young Children With Cerebral Palsy in Vietnam
Official title: Effect of Parent-delivered Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Young Children With Cerebral Palsy in Vietnam
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: HABIT-ILE
Cerebral Palsy
Caregiver -delivered
Intensive therapy
Home rehabilitation
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: University of Medicine and Pharmacy at Ho Chi Minh City
First posted: 2024-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial will be a single-blind, randomized controlled trial. Participants will be randomly assigned to one of two groups: HABIT-ILE Camp with Caregivers or HABIT-ILE at Home with Caregivers. Both groups will have longitudinal assessments two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Gross Motor Function Measure -66 (GMFM- 66)
timeFrame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
measure: Melbourne Assessment 2
timeFrame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
Secondary outcomes:
measure: ACTIVLIM-CP-WA questionnaire
timeFrame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
measure: Paediatric Evaluation of Disability Inventory (PEDI)
timeFrame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
measure: The Canadian Occupational Performance Measure (COPM)
timeFrame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
measure: WHOQOL-BREF
timeFrame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
Other outcomes:
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