Clinical Trial

Functional and Neuroplastic Effects of HABIT-ILE in Children With Bilateral Cerebral Palsy

Study acronym: FuN HABIT-ILE
Recruiting
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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; n=24) versus a single period (1HG; n=24) 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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-05-20; most recent amendment 2024-07-09.
Status change: Not Yet Recruiting → Recruiting 2024-07-09
Trial Details
NCT Number NCT06428032
Lead Sponsor Universidad Nacional Andres Bello
Conditions Cerebral Palsy
Enrollment 48 participants
Start Date 2024-06-03
Primary Completion 2026-09-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-07-11