HABIT-ILE therapy for children with acquired brain injury
Implementation of a HABIT-ILE Intervention at William Lennox Neurological : a Randomized Controlled Trial
This study is testing a new therapy called HABIT-ILE to see if it can help children aged 5 to 18 with brain injuries improve their daily activities and skills better than regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Université Catholique de Louvain Academic / other |
| Locations | 3 sites (Ottignies-Louvain-la-Neuve, Brabant-Wallon and 2 other locations) |
| Trial ID | NCT05900778 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in a hospital setting for children aged 5 to 18 with acquired brain injuries. It employs a randomized controlled trial design to compare the outcomes of HABIT-ILE therapy against conventional therapies. The study aims to assess improvements in functional activities of daily living, motor skills, and cognitive abilities through clinical evaluations conducted before and after the treatment. The goal is to provide objective evidence of the therapy's effectiveness in enhancing the quality of life for affected children.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5 to 18 years with acquired brain injuries who are stable and can participate in the intervention.
Not a fit: Patients with unstable seizures or severe visual or cognitive impairments that interfere with the intervention or testing are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve motor and cognitive functions in children with acquired brain injuries, enhancing their daily living activities.
How similar studies have performed: Other studies have shown promising results with intensive therapy approaches for similar conditions, suggesting potential success for this novel application of HABIT-ILE.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * children with acquired brain injury of school * age 5 to 18 years inclusive Exclusion Criteria: * Unstable seizure * programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time * Severe visual or cognitive impairments likely to interfere with intervention or testing session completion
Where this trial is running
Ottignies-Louvain-la-Neuve, Brabant-Wallon and 2 other locations
- Centre Hospitalier Neurologique William Lennox — Ottignies-Louvain-la-Neuve, Brabant-Wallon, Belgium (Recruiting)
- Institute of Neurosciences, UCLouvain — Brussels, Belgium (Recruiting)
- Spontaneous contact via doctors or other partners — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Yannick Bleyenheuft, Professor — Insititue of Neurosciences, UCLouvain
- Study coordinator: Yannick Bleyenheuft, Professor
- Email: yannick.bleyenheuft@uclouvain.be
- Phone: +32 2 764 93 49
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.