NCT06428032 Functional and Neuroplastic Effects of HABIT-ILE in Children With Bilateral Cerebral Palsy
| NCT ID | NCT06428032 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Nacional Andres Bello |
| Condition | Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-06-03 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2024-06-03 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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; 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.
Eligibility Criteria
Inclusion Criteria: * Children with medical diagnosis of bilateral cerebral palsy * Cognitive capacity and language that allows understanding and following the therapist's instructions. * Manual Ability Classification System (MACS) levels I to III * Bimanual Fine Motor Function (BFMF) levels I to III * Gross Motor Function Classification System (GMFCS) levels I to III Exclusion Criteria: * Severe visual problems * Movement restriction due to orthopedic surgery in less than a year * Treatment with botulinum toxin and/or baclofen pump in the last 6 months * Contraindications to receive transcranial magnetic stimulation (epileptic history, metallic implants, neoplasm, etc.)
Contact & Investigator
Rodrigo Araneda, PhD
PRINCIPAL INVESTIGATOR
Universidad Nacional Andres Bello
Frequently Asked Questions
Who can join the NCT06428032 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06428032 currently recruiting?
Yes, NCT06428032 is actively recruiting participants. Contact the research team at rodrigo.araneda@unab.cl for enrollment information.
Where is the NCT06428032 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT06428032 clinical trial?
NCT06428032 is sponsored by Universidad Nacional Andres Bello. The principal investigator is Rodrigo Araneda, PhD at Universidad Nacional Andres Bello. The trial plans to enroll 48 participants.
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