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

NCT ID: NCT06593158

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-08-01

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HABIT-ILE at Camp with Caregivers

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

• 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 in the afternoon.

HABIT-ILE at Home with Caregivers

Group Type: ACTIVE_COMPARATOR

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.

Intervention Type: BEHAVIORAL

• 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 afternoon.

Interventions

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 in the afternoon.

Intervention Type: 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.

• 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 afternoon.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role: collaborator

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yannick Bleyenheuft, Phd, Prof

Role: CONTACT

Yannick.bleyenheuft@uclouvain.be

+324869 99 11

Doan MN Nguyen, Phd

Role: CONTACT

doan.nguyen@uclouvain.be

+84 392332846

Other Identifiers

Parent-delivered HABIT-ILE

Identifier Type: -

Identifier Source: org_study_id