Home-based therapy for children with bilateral cerebral palsy
Implementation of a HABIT-ILE at Home Intervention for Children With Bilateral Cerebral Palsy: a Non-inferiority Randomized Controlled Trial
This study is testing whether a home-based therapy program for children with bilateral cerebral palsy can help them improve their movement and independence compared to traditional therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Université Catholique de Louvain Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT05740605 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a home-based version of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for children with bilateral cerebral palsy. It aims to compare two intensive treatment programs: traditional HABIT-ILE and HABIT-ILE at home, utilizing a virtual device and remote supervision. The study will include 48 children aged 5 to 18 years and assess their motor function and daily life independence over a two-week period. Additionally, it will investigate the benefits of follow-up therapy at home after the initial treatment.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 18 years with a confirmed diagnosis of bilateral cerebral palsy who can follow simple instructions.
Not a fit: Patients with uncontrolled seizures, severe cognitive impairments, or those who have undergone recent intensive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve motor function and independence in daily activities for children with cerebral palsy.
How similar studies have performed: Previous studies have shown the effectiveness of HABIT-ILE in improving motor skills in children with cerebral palsy, indicating a promising approach for this home-based intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children with confirmed diagnosis of bilateral Cerebral Palsy * Age 5 to 18 years old * Ability to interact and understand simple instructions in order to complete assessments and therapy * Availability of a caregiver for 6h30 per day during two weeks of therapy Exclusion Criteria: * Uncontrolled seizure * Botulinum toxin injection in the last 6 months before the first assessment or during the therapy * Intensive therapy in the last 6 months before the first assessment or during the therapy * Surgery that could affect the assessments or therapy in the last 6 months before the first assessment or during the therapy * Severe visual or cognitive impairments interfering with treatment and or assessments * Any typical contraindication for MRI
Where this trial is running
Brussels
- MSL-IN Lab, Institue of Neurosciences, UCLouvain — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Yannick Bleyenheuft, Phd, Prof. — Université Catholique de Louvain
- Study coordinator: Yannick Bleyenheuft, Phd, Prof.
- Email: yannick.bleyenheuft@uclouvain.be
- Phone: +32 486 91 99 11
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.