Multisensory Stimulation and Priming (MuSSAP) in 4-10 Months Old Infants with a Unilateral Brain Lesion: A Pilot Randomised Clinical Trial.

Only 16 infants with a brain lesion took part, eight in each group, so the study was too small to reliably detect a difference between the two programmes. There was no group of infants who received no intervention, because the researchers judged it unethical to withhold early training. The improvements seen in both groups therefore cannot be separated from the infants growing and developing over the two to four months between assessments. Scoring was not blinded: the occupational therapist who coached families also carried out the assessments, since she was the only certified assessor at the clinic. Five assessments were re-scored by a second assessor elsewhere to limit this. Six infants' hand function got worse between the end of treatment and the eight-week follow-up, which may mean eight weeks of training was too short for a lasting change, although for most of them function was still better than before treatment. The two groups differed in other ways: the wristband group included more infants with epilepsy and one with respiratory disease, which may explain the lower quality of life scores in that group rather than the training itself. Two infants in the wristband group received less than half the planned training because of hospital admissions and difficulty fitting it into daily life, and neither improved. Attention was judged by whether the baby looked at the wristband, which is only a stand-in for attention to the affected arm, and the parent-recorded videos were sometimes of poor quality and slow to score. The researchers call for a better attention measure in future studies. There was no measure of attention at the start of the study, so it is not known whether the groups were comparable on this. The infants varied considerably from one another, and the site and severity of the brain damage may matter more than which training was given. One infant in the wristband group turned out to score within the normal range and would have been excluded had the cut-off values been available, though excluding that infant did not change the conclusions.

Do not read the improvements in both groups as proof that either programme works. There was no untreated comparison group, so gains over the eight weeks cannot be separated from normal development, and with eight infants per group the trial was far too small to show a difference between the two programmes. The idea that the wristband might suit infants who do not yet reach with the affected arm is an untested hypothesis from looking at a few individual charts, not a result.