Fidelity of Delivery in a Multisite Randomized Clinical Trial of Intervention Efficacy for Infants With Unilateral Cerebral Palsy.

Abstract

To investigate the reliability of a measure of fidelity of therapist delivery, quantify fidelity of delivery, and determine factors impacting fidelity in the Rehabilitation EArly for Congenital Hemiplegia (REACH) clinical trial. Ninety-five infants (aged 3-9 months) with unilateral cerebral palsy participated in the REACH clinical trial. The Therapist Fidelity Checklist (TFC) evaluated key intervention components. Video-recorded intervention sessions were scored using the TFC. Inter- and intrarater reliability was percentage agreement 77% to 100%. Fidelity of delivery was high for 88.9% of sessions and moderate for 11.1% of sessions. Sessions with moderate scores included infants receiving infant-friendly bimanual therapy and occurred at the intervention midpoint or later. No significant relationships were found for TFC scores and infant age, manual ability, or parent engagement. Fidelity of delivery was high for the REACH trial in most intervention sessions. Standardized therapist training with intervention manuals and monthly peer-to-peer support likely contributed to these results.