Association of a HABIT-ILE Course and a Home Programme on the Bimanual Performance of Children With Cerebral Palsy
Launched by FONDATION ILDYS · May 6, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how two different therapy programs can help young children with cerebral palsy use both hands better. Specifically, it compares a new program that combines 35 hours of a special therapy called HABIT-ILE with 15 hours of home exercises to a standard HABIT-ILE program that lasts 50 hours. The goal is to see if the new approach is just as effective in improving the ability of children aged 3 to 5 years with unilateral cerebral palsy (which means affecting one side of the body) to perform tasks using both hands.
To be eligible for this trial, children must be diagnosed with unilateral cerebral palsy and be between 3 years and 5 years 11 months old. They should be able to pick up a light object with their affected hand and lift it off the table. Parents or guardians will need to commit to being involved throughout the study and must provide written consent. Unfortunately, children with certain conditions like ataxic cerebral palsy or uncontrolled epilepsy cannot participate. If your child meets the criteria, they may have the chance to be part of this important research that aims to improve therapy options for young children with cerebral palsy.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Child with unilateral CP confirmed by a physician
- • 2. Child aged between 3 years and 5 years 11 months (corrected age) at study entry
- • 3. Ability to grasp a light object and lift it ≥15cm above the table using the affected hand.
- • 4. Ability to understand instructions and complete all assessments.
- • 5. Matched with another child based on age (± 3 months), CP aetiology, and Manual Ability Classification System (MACS) level.
- • 6. Written informed consent obtained from a parent or legal guardian.
- • 7. Commitment to having the same parent or guardian participate throughout the study.
- Exclusion Criteria:
- • 1. Diagnosis of ataxic CP.
- • 2. Uncontrolled epilepsy.
- • 3. History of botulinum toxin injection or surgery within 6 months of study entry or scheduled within 3 months of the intervention (ie, during the study period).
- • 4. Visual or auditory deficits that could interfere with participation in the study.
- • 5. Significant cognitive or behavioural disorder limiting the ability to follow instructions, as reported in discussions with the family, therapists and/or during a prior assessment
About Fondation Ildys
Fondation Ildys is a dedicated clinical trial sponsor focused on advancing medical research and improving patient outcomes through innovative therapeutic solutions. Committed to high ethical standards and scientific excellence, the foundation collaborates with healthcare professionals, researchers, and institutions to facilitate the development and evaluation of new treatments across various therapeutic areas. By fostering a culture of collaboration and transparency, Fondation Ildys aims to drive clinical advancements that address unmet medical needs and enhance the quality of life for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brest Cedex 2, , France
Patients applied
Trial Officials
Rodolphe BAILLY
Principal Investigator
Fondation Ildys
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported