START-Play Physical Therapy Intervention Impacts Motor and Cognitive Outcomes in Infants With Neuromotor Disorders: A Multisite Randomized Clinical Trial.
Regina T Harbourne, Stacey C Dusing, Michele A Lobo and 11 others
PMID 33382406WHAT IT FOUND
Infants with significant motor delays showed short-term gains in sitting, fine motor skills, and problem solving with START-Play.
Infants with mild delays showed no benefit and some negative long-term motor trends. The study was underpowered, so results are tentative.
Key findings
01For infants with significant motor delays, START-Play produced significant short-term improvements in problem solving, cognition, and fine motor skills, plus substantively important gains in sitting and gross motor function.
02For infants with mild motor delays, START-Play showed no significant long-term benefits and substantively important negative effects on reaching and gross motor scores compared to usual care.
03The study was underpowered because only 112 infants met analysis criteria, falling short of the 152 needed for the planned effect sizes.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTsWhat it means for SLPs
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What it does not show
The study was underpowered, as only 112 infants were analyzed compared to the 152 required by the power analysis. The dose of intervention was not equal between groups, as START-Play was added to usual care. The problem-solving assessment (APSP) may be biased toward motor ability, making it difficult to interpret cognitive gains independently of motor improvements. Attrition was 21%, and completers differed from dropouts in race, ethnicity, and socioeconomic status, potentially introducing bias. Baseline imbalances existed in the mild delay group, with the START-Play group starting with higher problem-solving scores, which may explain the subsequent 'negative' effect as regression to the mean.
Declared interests
The funding source had no role in the study’s design, conduct, and reporting.
The easy way to misread this
Do not interpret the negative effects in the mild delay group as harm caused by the intervention. The START-Play group in this subgroup had significantly higher baseline problem-solving scores, so the difference at 3 months may represent regression to the mean rather than a true decline.