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The SIT-PT Trial Protocol: A Dose-Matched Randomized Clinical Trial Comparing 2 Physical Therapist Interventions for
Stacey C Dusing1, Regina T Harbourne2, Lin-Ya Hsu3
1Ostrow School of Dentistry, Division of Physical Therapy and Biokinesiology, University of Southern California, Los Angeles, California, USA.
Insights
This study compares two early intervention programs for infants at high risk for cerebral palsy (CP). It aims to determine which approach, focusing on play-based activities or targeted exercises, yields better developmental outcomes for children with CP.
Area of Science:
- Pediatrics
- Developmental Neuroscience
- Physical Therapy
Background:
- Early intervention is recommended for infants at risk of cerebral palsy (CP).
- Current interventions for CP lack standardized descriptions and have mixed evidence.
- Interventions are often based on differing domains of the International Classification of Functioning, Disability and Health (ICF).
Purpose of the Study:
- To compare the efficacy of two distinct early intervention programs for infants at high risk for cerebral palsy.
- To evaluate developmental outcomes based on interventions grounded in different ICF domains.
- To inform the selection of effective intervention principles for infants with or at high risk of CP.
Main Methods:
- Randomized controlled trial involving 150 infants (8-24 months) with motor delays and signs of neurologic impairment.
- Two intervention groups: Sitting Together and Reaching To Play (play-based) and Movement, Orientation, Repetition, Exercise Physical Therapy (exercise-based).
- Interventions delivered twice weekly for 3 months, with follow-up at 3, 6, 9, and 12 months. Outcome measures include the Gross Motor Function Measure and Bayley Scales of Infant Development-IV.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- This study represents a novel comparison of dose-matched, early physical therapy interventions with clearly defined principles.
- Findings will guide the choice of intervention strategies for infants at risk of or diagnosed with cerebral palsy.
- The research aims to enhance the effectiveness of early interventions by identifying key beneficial components.
Objective:
Although early intervention for infants at risk for cerebral palsy is routinely recommended, the content of intervention is poorly described, varies widely, and has mixed supporting evidence. The purpose of this study was to compare efficacy of 2 interventions grounded in differing domains of the International Classification of Functioning, Disability and Health on developmental outcomes of infants with or at high risk of cerebral palsy.
Methods:
Infants who meet inclusion criteria will be randomized into either Sitting Together and Reaching To Play or Movement, Orientation, Repetition, Exercise Physical Therapy groups. Both groups will receive intervention twice weekly for 3 months and follow-up at 3, 6, 9, and 12 months from baseline. The primary objectives compare changes over time and between groups in sitting, gross motor, and cognitive development. The setting is the infant's home unless the caregiver requests otherwise. One hundred and fifty infants between 8 and 24 months of age will be enrolled in 3 geographically, racially, and ethnically diverse sites: Los Angeles, California; Omaha, Nebraska; and Seattle, Washington. Enrolled infants will demonstrate motor delays, emerging sitting skills, and signs of neurologic impairment. Sitting Together and Reaching To Play targets activities including sitting, reaching, and motor-based problem solving to improve global development. In contrast, Movement, Orientation, Repetition, Exercise Physical Therapy focuses on strengthening and musculoskeletal alignment while encouraging repeated movement practice. Outcome measures include the Gross Motor Function Measure, Bayley Scales of Infant Development-IV, Assessment of Problem Solving in Play, and a Parent Child Interaction assessment. Enrolled children will maintain usual intervention services due to ethical concerns with intervention withdrawal.
Impact:
This will be the first study, to our knowledge, comparing efficacy of early physical therapy with dose-matched interventions and well-defined key principles. The outcomes will inform selection of key principle of intervention in this population.
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