2.2. Participants
deafness, sensory deficits, brain abnormalities, blindness, epilepsy, haemorrhage
EPILEPSY, HAEMORRHAGE, BLINDNESS, MIDDLE CEREBRAL ARTERY STROKE
In this pilot RCT study we aimed to include sixteen infants with a unilateral brain lesion. Additionally, as the norm reference scores for the Hand Assessment for Infants (HAI) [Infants with a (corrected) age between 4 and 10 months at risk for uCP were recruited from eight hospitals across the Netherlands. Eligibility criteria were a diagnosis of unilateral acquired brain abnormalities (parenchymal haemorrhage or middle cerebral artery stroke) i.e. should be at risk of uCP, based on at least one cerebral imaging study (ultrasound or MRI). Exclusion criteria were severe epilepsy, severe sensory deficits (blindness, deafness), bilateral involvement, or both parents being unable to communicate in Dutch, English, or German.Parents of eligible infants received an information letter about the study from their medical doctor. If interested, parents were invited for a visit to the rehabilitation center. During the visit an initial observation of the infant's motor performance was conducted by a paediatric rehabilitation physician and an occupational therapist. Parents received additional oral and written information about the intervention and detailed information about the study procedure. All parents of the participating infants signed an informed consent prior to participation. Infants were randomised to the intervention groups by using block randomisation. Every first infant referred by a paediatric neurologist from one of the hospitals was allocated either to EI-UL or EI-UL–MuSSAP by drawing lots (without replacement) by an independent person. Every second infant referred by the same hospital was automatically allocated to the other intervention group.The typically developing infants were age-matched to the infants in the MuSSAP group and recruited from a child daycare centre. These infants had to be born at term and have a normal birth weight as reported by the parents.