Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-01-09 @ 4:30 PM
Study NCT ID:
NCT04698395
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2020-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HABIT-ILE in Infants and Toddlers With Cerebral Palsy (Baby HABIT-ILE)
Sponsor:
Université Catholique de Louvain
Organization:
Study Overview
Official Title:
Effects of HABIT-ILE in Secondary Brain Damage Outcomes of Infants and Toddlers With Signs of Cerebral Palsy
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
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:
Baby HABIT-ILE
Brief Summary:
Using a randomized controlled trial design, the possible changes induced by the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" in functional, everyday life activities and neuroplastic assessment will be studied in infants and toddlers with cerebral palsy.
Detailed Description:
Using a randomized controlled trial design, the possible changes in neuroimaging, motor function and everyday life activities of infants and toddlers at risk of or with a diagnosis of cerebral palsy after participating of the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" will be studied . Changes, scored by parents in case of questionnaires and by experts in the case of tests, will be observed comparing infants/toddlers after their regular care and after receiving HABIT-ILE. Motor function and daily life activities will be correlated with neuroplastic changes. Moreover, possible therapy onset outcomes differences will be observed.
Study Oversight
Has Oversight DMC:
False
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?: