Association of a HABIT-ILE Course and a Home Programme on the Bimanual Performance of Children With Cerebral Palsy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-5
SponsorFondation Ildys

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

66 Participants
are divided into 2 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