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

Kimberley Scott1, Leanne Sakzewski, Jenny Ziviani

  • 1Department of Physical Therapy (Dr Scott), Creighton University, Omaha, Nebraska; Queensland Cerebral Palsy and Rehabilitation Research Centre (Drs Sakzewski and Boyd), Child Health Research Centre, Faculty of Medicine, and School of Health and Rehabilitation Sciences (Dr Ziviani), The University of Queensland, Brisbane, Queensland, Australia; Division of Physical Therapy (Dr Heathcock), The Ohio State University, Columbus, Ohio.

Insights

Therapist fidelity in the Rehabilitation EArly for Congenital Hemiplegia (REACH) trial was high, with the Therapist Fidelity Checklist (TFC) showing good reliability. Standardized training and support likely ensured consistent intervention delivery.

Area of Science:

  • Pediatric Rehabilitation
  • Clinical Trial Methodology
  • Neurodevelopmental Disorders

Background:

  • Congenital hemiplegia significantly impacts child development.
  • Early intervention is crucial for improving outcomes in infants with unilateral cerebral palsy.
  • Ensuring consistent and high-quality therapist delivery is vital for intervention efficacy.

Purpose of the Study:

  • To assess the reliability and quantify the fidelity of therapist delivery in the Rehabilitation EArly for Congenital Hemiplegia (REACH) clinical trial.
  • To identify factors influencing therapist fidelity during early intervention for congenital hemiplegia.
  • To validate the Therapist Fidelity Checklist (TFC) as a measure of intervention adherence.

Main Methods:

  • Ninety-five infants (3-9 months) with unilateral cerebral palsy participated in the REACH trial.
  • Therapist delivery was evaluated using the Therapist Fidelity Checklist (TFC) on video-recorded sessions.
  • Inter- and intrarater reliability of the TFC was calculated using percentage agreement.

Main Results:

  • The TFC demonstrated good inter- and intrarater reliability (77%-100% agreement).
  • High fidelity of delivery was observed in 88.9% of intervention sessions.
  • Moderate fidelity was noted in 11.1% of sessions, particularly those involving infant-friendly bimanual therapy later in the intervention period.

Conclusions:

  • High fidelity of therapist delivery was achieved in the majority of REACH trial sessions.
  • Standardized therapist training and ongoing peer support were likely key factors in maintaining high fidelity.
  • The TFC is a reliable tool for measuring and ensuring intervention fidelity in pediatric rehabilitation trials.
Abstract

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