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START-play physical therapy intervention impacts motor and cognitive outcomes in infants with neuromotor disorders: a multisite randomized clinical trial [with consumer summary] |
Harbourne RT, Dusing SC, Lobo MA, McCoy SW, Koziol NA, Hsu L-Y, Willett S, Marcinowski EC, Babik I, Cunha AB, An M, Chang H-J, Bovaird JA, Sheridan SM |
PTJ: Physical Therapy & Rehabilitation Journal 2021 Feb;101(2):pzaa232 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: No; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: Our objective was to evaluate the efficacy of the sitting together and reaching to play (START-play) intervention in young infants with neuromotor disorders. METHOD: This randomized controlled trial compared usual care early intervention (UC-EI) with START-play plus UC-EI. Analyses included 112 infants with motor delay (55 UC-EI, 57 START-play) recruited at 7 to 16 months of age across 5 sites. START-play included twice-weekly home visits with the infant and caregiver for 12 weeks provided by physical therapists trained in the START-play intervention; UC-EI was not disrupted. Outcome measures were the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley); the Gross Motor Function Measure; reaching frequency; and the Assessment of Problem Solving in Play (APSP). Comparisons for the full group as well as separate comparisons for infants with mild motor delay and infants with significant motor delay were done. Piecewise linear mixed modeling estimated short- and long-term effects. RESULTS: For infants with significant motor delay, positive effects of START-play were observed at 3 months for Bayley cognition, Bayley fine motor, and APSP and at 12 months for Bayley fine motor and reaching frequency outcomes. For infants with mild motor delay, positive effects of START-play for the Bayley receptive communication outcome were found. For the UC-EI group, the only difference between groups was a positive effect for the APSP outcome, observed at 3 months. CONCLUSIONS: START-play may advance reaching, problem-solving, cognitive, and fine motor skills for young infants with significant motor delay over UC-EI in the short term. START-play in addition to UC-EI may not improve motor/cognitive outcomes for infants with milder motor delays over and above usual care. IMPACT: Concepts of embodied cognition, applied to early intervention in the START-play intervention, may serve to advance cognition and motor skills in young infants with significant motor delays over usual care early intervention.
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