Status:
NOT_YET_RECRUITING
Association of a HABIT-ILE Course and a Home Programme on the Bimanual Performance of Children With Cerebral Palsy
Lead Sponsor:
Fondation Ildys
Collaborating Sponsors:
University Hospital, Angers
LP3C, University of Rennes 2
Conditions:
Cerebral Palsy
Eligibility:
All Genders
3-5 years
Phase:
NA
Brief Summary
This non-inferiority, mixed-methods, multicentre randomised controlled trial will compare the effects of functional changes and families' resources at 3 months of the PARTNER programme (35h HABIT-ILE ...
Detailed Description
The PARTNERSHIP study will compare, for the first time, a mixed PARTNER camp modality, including a HABIT-ILE camp modality and a home programme modality, with parental coaching, to a reference HABIT-I...
Eligibility Criteria
Inclusion
- Child with unilateral CP confirmed by a physician
- Child aged between 3 years and 5 years 11 months (corrected age) at study entry
- Ability to grasp a light object and lift it ≥15cm above the table using the affected hand.
- Ability to understand instructions and complete all assessments.
- Matched with another child based on age (± 3 months), CP aetiology, and Manual Ability Classification System (MACS) level.
- Written informed consent obtained from a parent or legal guardian.
- Commitment to having the same parent or guardian participate throughout the study.
Exclusion
- Diagnosis of ataxic CP.
- Uncontrolled epilepsy.
- 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).
- Visual or auditory deficits that could interfere with participation in the study.
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06963151
Start Date
January 1 2026
End Date
September 1 2028
Last Update
December 16 2025
Active Locations (1)
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1
Fondation ILDYS
Brest, France, France, 29218