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Early physical therapy effects on the high-risk infant: a randomized controlled trial
Piper MC, Kunos VI, Willis DM, Mazer BL, Ramsay M, Silver KM
Pediatrics 1986 Aug;78(2):216-224
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: Yes; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

A prospective, randomized, controlled trial was conducted to assess the effects of early physical therapy on infants at risk for neurologic sequelae and to evaluate the impact of such early treatment on the prevention or minimization of future handicaps. A cohort of 134 infants who had received care in two Montreal inborn neonatal intensive care units was identified prospectively. Infants were stratified according to prognosis and birth weight and were randomly assigned to either an experimental or control group. Babies assigned to the experimental group received early physical therapy, whereas those allocated to the control group received conventional follow-up care. Outcome measures were administered by independent evaluators at 12 months and included measures of neurologic status, motor and overall development, and physical growth. No statistically significant differences on any of the measured outcomes at 12 months were found between the experimental and control groups. Infants weighing less than 750 g at birth, regardless of group assignment, consistently demonstrated significant delays in their growth and development when compared with their heavier peers. The early physical therapy program investigated in this study was not efficacious in altering the pattern of motor development in those high-risk infants participating in the trial.
Reproduced with permission from Pediatrics. Copyright by the American Academy of Pediatrics.

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