Effects of intensive therapy on motor skills in children with cerebral palsy
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
This study is testing whether more hours of a special therapy can help improve motor skills in children with bilateral cerebral palsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Universidad Nacional Andres Bello Academic / other |
| Locations | 1 site (Santiago, Santiago Metropolitan) |
| Trial ID | NCT06428032 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on children with bilateral cerebral palsy. It compares two groups: one receiving a single period of therapy totaling 65 hours and another receiving double the therapy over two periods totaling 130 hours. Participants will be assessed at multiple time points to evaluate both functional and neuroplastic changes resulting from the therapy. The study aims to provide insights into the effectiveness of intensive therapy and its potential dose-response relationship.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with bilateral cerebral palsy who can understand and follow instructions.
Not a fit: Patients with severe visual problems or recent orthopedic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve motor function and neuroplasticity in children with bilateral cerebral palsy.
How similar studies have performed: Previous studies on intensive therapy approaches have shown promising results, suggesting potential success for this novel comparison.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Santiago, Santiago Metropolitan
- Exercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello — Santiago, Santiago Metropolitan, Chile (Recruiting)
Study contacts
- Principal investigator: Rodrigo Araneda, PhD — Universidad Nacional Andres Bello
- Study coordinator: Rodrigo Araneda, PhD
- Email: rodrigo.araneda@unab.cl
- Phone: +56 22 6618608
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.