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

Sponsor
Fondation Ildys
Study ID
NCT06963151
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
3 Years - 5 Years
Healthy Volunteers
Not accepted

Interventions

  • Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities — OTHER
    * Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities. * Home programme with parental coaching
  • Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities — OTHER
    \- Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.

Study Details

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.

Key Dates

First listed
May 8, 2025
Start date
Jan 1, 2027
Status verified
Apr 2026
Primary completion
Sep 1, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: PARTNER
    Subjects will receive 35 hours of HABIT-ILE as camp format 3,5h/day, 5 days/week and 15 hours of home programme 1,5h/day, 5 day/week. These two procedures will be carried out concurrently over a 2-week period.
  • Experimental: HABIT-ILE
    Subjects will receive 50 hours of HABIT-ILE as camp format 5h/day, 5 days/week for two weeks.

Primary Outcome Measure

Assisting Hand Assessment (AHA) [ Time Frame: 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) ]

Central Contacts

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