Not Yet RecruitingNot Applicable

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

France66 participantsStarted 2027-01-01

Plain-language 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 + 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.

Who can participate

Age range3 Years – 5 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Assisting Hand Assessment (AHA)

Timeframe: At the baseline (T0), at the end of the camp (T1: T0 + 21 + 2 days), and during the follow-up visit (T2: T0 + 90+2 days)

Trial details

NCT IDNCT06963151

SponsorFondation Ildys

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-09-01

Contact for this trial

Manon LE GOFF

0298028308 manon.legoff@ildys.org

View on ClinicalTrials.gov More Cerebral Palsy trials