Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428032
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-05-20
Brief Title:
Functional and Neuroplastic Effects of HABIT-ILE in Children With Bilateral Cerebral Palsy
Sponsor:
Universidad Nacional Andres Bello
Organization:
Universidad Nacional Andres Bello
Study Overview
Official Title:
Functional and Neuroplastic Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities HABIT-ILE in Children With Bilateral Cerebral Palsy a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
FuN HABIT-ILE
Brief Summary:
This randomized controlled trial will compare the effects of neuroplastic and functional changes of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities HABIT-ILE when presented in two periods 2HG n24 versus a single period 1HG n24 in people with bilateral CP The 1HG will receive 65 hours of HABIT-ILE over one intervention period the 2HG will receive 130 hours over two intervention periods within 6 months apart Children will be assessed at 6 time points baseline three weeks after the start at 3 6 7 and 9 months after the start of the study
Detailed Description:
This study aims to compare for the first time the effects of a double period of HABIT-ILE therapy on functional and neuroplastic changes against a single period in people with bilateral cerebral palsy CP Previous HABIT-ILE protocols have only assessed the effects of a single intervention period Still the literature suggests a possible dose-response relationship between the number of intensive therapy periods and progress in motor function
A randomized controlled trial will be conducted comparing the effects of a double period of HABIT-ILE 2HG n24 versus a single period 1HG n24 in children and youth with bilateral CP Each HABIT-ILE period will consider 65 hours of intervention during 10 consecutive working days Children will be assessed at 6-time points baseline three weeks after at 3 months at 6 months at 7 months and at 9 months to evaluate the long-term effect of HABIT-ILE and the summative effects of the double period in functional and neuroplastic variables The 1HG will receive only 65 hours of HABIT-ILE after baseline the 2HG will perform 130 hours over two intervention periods after baseline and again at 6 months
Overall this study aims to provide evidence for the effectiveness of HABIT-ILE in producing functional and neuroplastic changes in children with bilateral CP It will allow us to approach the possible mechanisms underlying the effect of HABIT-ILE
A randomized controlled trial will be conducted comparing the effects of a double period of HABIT-ILE 2HG n24 versus a single period 1HG n24 in children and youth with bilateral CP Each HABIT-ILE period will consider 65 hours of intervention during 10 consecutive working days Children will be assessed at 6-time points baseline three weeks after at 3 months at 6 months at 7 months and at 9 months to evaluate the long-term effect of HABIT-ILE and the summative effects of the double period in functional and neuroplastic variables The 1HG will receive only 65 hours of HABIT-ILE after baseline the 2HG will perform 130 hours over two intervention periods after baseline and again at 6 months
Overall this study aims to provide evidence for the effectiveness of HABIT-ILE in producing functional and neuroplastic changes in children with bilateral CP It will allow us to approach the possible mechanisms underlying the effect of HABIT-ILE
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