Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04899284
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2021-05-18
Brief Title:
Impact of Early Intensive Stimulation on Bimanual Function in Infants at High Risk of Unilateral CP BB-BIM
Sponsor:
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Organization:
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Study Overview
Official Title:
Impact of Early and Intensive Bimanual Stimulation on the Evolution of Bimanual Function in Infants With Clinical Findings Suggesting Unilateral Cerebral Palsy BB-BIM
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BB-BIM
Brief Summary:
The aim of this study is to measure the impact of early bimanual stimulation in babies with clinical signs of underuse of one hand The observation focuses on the developmental curve of hands use The intervention is provided by the family environment and takes place in the childs familiar surroundings
Detailed Description:
Congenital hemiplegia often referred to as Unilateral Cerebral Palsy UCP is characterized by a unilateral or asymmetrical brain injury that occurs around birth and impacts the development of manual skills and motor abilities of one side of the body
Affected children frequently develop hemiplegia with major limitations in the use of their impaired hand resulting in poor bimanual coordination thus impacting the performance of daily activities at home school and in the community
Several intensive therapy approaches currently exist including the bimanual approach BIM which aims to improve the use of the affected hand as an assisting hand in daily functional activities These approaches have long been established as effective however with these children reaching 90 of their potential gross motor skills around the age of 5 or even earlier in some cases there is a growing interest in earlier approaches well before school age It has also long been established that during the first year of life there is a critical time frame for hand motor development
The investigators have thus set up an intensive bimanual stimulation program for infants showing early signs of UCP delivered by the family environment in the childs familiar surroundings under the guidance of a therapist over a period of 2 months
Affected children frequently develop hemiplegia with major limitations in the use of their impaired hand resulting in poor bimanual coordination thus impacting the performance of daily activities at home school and in the community
Several intensive therapy approaches currently exist including the bimanual approach BIM which aims to improve the use of the affected hand as an assisting hand in daily functional activities These approaches have long been established as effective however with these children reaching 90 of their potential gross motor skills around the age of 5 or even earlier in some cases there is a growing interest in earlier approaches well before school age It has also long been established that during the first year of life there is a critical time frame for hand motor development
The investigators have thus set up an intensive bimanual stimulation program for infants showing early signs of UCP delivered by the family environment in the childs familiar surroundings under the guidance of a therapist over a period of 2 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None