UnknownNot Applicable

Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy

Belgium, France, Italy100 participantsStarted 2018-11-27

Plain-language summary

Studying in two randomized controlled trials (RCT) the changes induced by early HABIT-ILE in functional, neuroplastic and biomechanical assessment in children with unilateral and bilateral CP.

Who can participate

Age range

12 Months – 59 Months

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: * children with unilateral or bilateral cerebral palsy (spastic or dyskinetic) * age 1 to 4 years inclusive (corrected age if preterm birth) * ability to follow instructions and complete testing according to the age. Exclusion Criteria: * active seizure * programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time * severe visual impairments * severe cognitive impairments * contraindications to perform MRI assessments (Metal implants, etc.)

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

Change on Gross Motor Function (GMFM-66)

Timeframe: pre-camp, two weeks post-camp, 3 months follow-up.

Change on Manual Ability (Assisting Hand Assessment (AHA))

Timeframe: pre-camp, two weeks post-camp, 3 months follow-up

Trial details

NCT IDNCT04020354

SponsorUniversité Catholique de Louvain

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

View on ClinicalTrials.gov More Cerebral Palsy trials

Who can participate

Age range

12 Months – 59 Months

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.