CompletedNot Applicable

Program Intensive Habilitation (PIH) for Young Children With Early Brain Damage

Norway93 participantsStarted 2021-10-10

Plain-language summary

By longitudinal, prospective research in children with neurodisabilities including severe motor impairments and their parents to explore the beneficial effects of participating in an intensive habilitation program on the child's adaptive functioning and parental empowerment in order to treat and reduce the consequences of early brain damage.

Who can participate

Age range

2 Years – 7 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: * age 2 - 6 years at the start of the program * a diagnosis of severe cerebral palsy or similar motor disability of non-progressive etiology (GMFCS level IV-V), * being able to participate in group sessions * having parents who want to take an active part in their child's training * least one of the parents must speak fluent Norwegian or English. Exclusion Criteria: * children with progressive disorders * co-morbidity like autism spectrum disorder, severe visual and hearing impairments or intractable epilepsy that worsen with physical activity.

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 in Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)

Timeframe: Change from baseline measure at 12 months and after 24 months

Change in Family Empowerment Scale (FES)

Timeframe: Change from baseline measure at12 months and after 24 months

Trial details

NCT IDNCT05093777

SponsorSorlandet Hospital HF

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Brain Injuries trials