Monitoring Treatment Fidelity in a Pragmatic Pediatric Rehabilitation Trial Comparing Two Physical Therapy Schedules: Analysis and Unexpected Findings.

Objective: This study aimed to describe the monitoring of treatment fidelity in a pragmatic pediatric rehabilitation trial using the National Institutes of Health Behavior Change Consortium framework, and to identify child and therapist factors that influence treatment fidelity.

Methods: Therapists (n = 28) were trained in the key ingredients (1-on-1, functional, goal-directed, motor learning intervention) and study protocol for a comparative effectiveness trial titled: A Comparison: High Intensity periodic vs. Every week therapy in children with cerebral palsy (ACHIEVE) for children ages 2 to 8 years with cerebral palsy. Therapists were instructed to record every tenth hour of treatment. A subset of recordings were used to monitor treatment fidelity so that each therapist was rated twice using the study- specific ACHIEVE Treatment Fidelity Checklist. Generalized linear mixed effects modeling and logistic regression were used to analyze child and therapist factors related to treatment fidelity.

Results: Median treatment fidelity scores were high (>80%). With training, therapist's years of experience and specialty certification do not significantly impact treatment fidelity. There is a trend toward lower treatment fidelity scores for children with communication difficulties, particularly for therapist's use of multi-modal instructions to direct the child in the desired activity.

Conclusion: Functional, goal-directed, motor learning intervention can be delivered with high fidelity for children with cerebral palsy within a busy clinical setting. Motor learning principles may be implemented differently for children with communication difficulties. More research is needed to explore optimal motor learning strategies for these children.

Impact: With training, physical therapists can deliver high-fidelity intervention to children with cerebral palsy across all Gross Motor Function Classification System levels within a busy clinical setting. Therapists may use motor learning principles differently in children with communication delays.