CompletedNot Applicable

Impact of Early Intensive Stimulation on Bimanual Function in Infants at High Risk of Unilateral CP (BB-BIM)

France5 participantsStarted 2021-04-21

Plain-language summary

The aim of this study is to measure the impact of early bimanual stimulation in babies with clinical signs of underuse of one hand. The observation focuses on the developmental curve of hands use. The intervention is provided by the family environment and takes place in the child's familiar surroundings.

Who can participate

Age range

3 Months – 12 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: * Baby between 3 and 12 months of age at the time of inclusion * Clinical signs of underuse of one of the two upper limbs, (reported by the parents and authenticated by the HAI) * Unilateral brain injury * Brain imaging performed at birth or upon initial parental concerns * Possibility of a home visit by the occupational therapist * At least one parent volunteering to actively participate in the intensive stimulation * Parental consent to enter the study * Consent for image rights Exclusion Criteria: * Prematurity * Lack of interest suggesting underlying associated disorders * Active epilepsy

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

Hand Assessment in Infants (HAI)

Timeframe: Change from baseline at 2 months with a weekly evaluation

Trial details

NCT IDNCT04899284

SponsorCentre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-01

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