CompletedNot Applicable

Early Intervention in Infants With Perinatal Stroke

Belgium60 participantsStarted 2016-06-29

Plain-language summary

This current study proposes to analyze the feasibility and effects of the two most used therapies, constraint-induced movement therapy and hand-arm bimanual intensive training, in very young infants (less than one year) with perinatal stroke and with a high risk to develop hemiplegic CP.

Who can participate

Age range

4 Months – 8 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: * Infants with a perinatal stroke confirmed on neonatal imaging and from who the parents speaks Dutch and live in Belgium, will be included in the study. Only infants showing abnormal 'general movements' between 10 and 15 weeks will be eligible for the intervention part. Exclusion Criteria: * Infants with severe genetic abnormalities or malformations, with severe visual impairments or with uncontrolled seizures will be excluded.

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 the score of the Hand assessment for infants (HAI)

Timeframe: before (around 4 months) and after 18 weeks of intervention (around 9 months)

Change in the score of the Infant motor profile

Timeframe: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up

Change in the score of the Alberta infant motor scale

Timeframe: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up

Trial details

NCT IDNCT02720432

SponsorUniversity Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03

View on ClinicalTrials.gov More Stroke trials

Who can participate

Age range

4 Months – 8 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.

What they're measuring

Change in the score of the Hand assessment for infants (HAI)

Timeframe: before (around 4 months) and after 18 weeks of intervention (around 9 months)

Change in the score of the Infant motor profile

Timeframe: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up

Change in the score of the Alberta infant motor scale

Timeframe: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up