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Search / Trial NCT06963151

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

Habit Ile Intensive Motor Therapy Motor Skill Learning Parental Coaching Children Additional Relavant Me Sh Terms Nervous System Diseases Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy

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.

Locations

Brest Cedex 2, , France

Patients applied

0 patients applied

Trial Officials

Rodolphe BAILLY

Principal Investigator

Fondation Ildys

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported