Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593158
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Parent-delivered HABIT-ILE in Young Children With Cerebral Palsy in Vietnam
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Parent-delivered Hand-arm Bimanual Intensive Therapy Including Lower Extremities HABIT-ILE in Young Children With Cerebral Palsy in Vietnam
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs 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
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 childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None