About this trial
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 + 15h home programme) with the reference HABIT-ILE programme (50h) on the bimanual performance (Assisting Hand Assessment \[AHA\]) of 66 children with unilateral CP aged 3 to 5 years.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
- Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
Treatment groups
Sponsors and collaborators
Fondation Ildys
Lead sponsor
University Hospital, Angers
Collaborator
University of Rennes 2
Collaborator
Claude Bernard University
Collaborator
IMT Atlantique Brest
Collaborator
INSERM UMR 1101
Collaborator