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

RecruitingNAAges 8 Years - 18 YearsAllUniversidad Nacional Andres Bello
NCT06428032 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.)
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What it tests

  • Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
  • Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
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Where

1 site
Exercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello
Santiago, Chile
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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