Association of a HABIT-ILE Course and a Home Programme on the Bimanual Performance of Children Wi… (NCT06963151) | Clinical Trial Compass
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 range
3 Years – 5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
. 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