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

Официальное название

Effect of Parent-delivered Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Young Children With Cerebral Palsy in Vietnam

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts.
  * The caregivers delivering HABIT-ILE therapy at camp will follow the same principles as the usual HABIT-ILE. The therapy will take place in a rehabilitation center, and caregivers will provide therapy during the sessions, coached by trained supervisors on site * The intervention day will then take place, lasting for 5 hours with the constant presence of supervisors. This will be divided into two sessions: a 3-hour intervention in the morning followed by a lunch break, and a 2-hour intervention
• Поведенческое 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.
  * The caregivers delivering HABIT-ILE therapy at home will follow the same principles as the usual HABIT-ILE. The therapy will take place at children's home, caregivers will provide therapy during the sessions, coached by trained supervisors online * The intervention day will then take place, lasting for 5 hours with the supervisors through online setting. This will be divided into two sessions: a 3-hour intervention in the morning followed by a lunch break, and a 2-hour intervention in the afte

Первичные конечные точки

• Gross Motor Function Measure -66 (GMFM- 66) [Срок оценки: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline]
• Melbourne Assessment 2 [Срок оценки: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline]

Вторичные конечные точки (4)

• ACTIVLIM-CP-WA questionnaire [Срок оценки: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline]
• Paediatric Evaluation of Disability Inventory (PEDI) [Срок оценки: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline]
• The Canadian Occupational Performance Measure (COPM) [Срок оценки: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline]
• WHOQOL-BREF [Срок оценки: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Nguyen MND, Le HTN, Nguyen TV, Do TP, Saussez G, Bleyenheuft Y. Parent-delivered Hand-arm Bimanual Intensive Training Including Lower Extremity for young children with bilateral cerebral palsy in Vietnam: protocol for a randomised controlled trial. BMJ Open. 2026 Jul 29;16(7):e113596. doi: 10.1136/bmjopen-2025-113596. PMID 42526925

Идентификаторы

NCT: NCT06593158 · Parent-delivered HABIT-ILE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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