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Randomized Controlled Trial
. 2023 Oct 1;35(4):458-466.
doi: 10.1097/PEP.0000000000001038.

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

Kimberley Scott  1 , Leanne Sakzewski, Jenny Ziviani, Jill C Heathcock, Roslyn N Boyd
Affiliations
Randomized Controlled Trial

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

Kimberley Scott et al. Pediatr Phys Ther. .

Abstract

Purpose: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Frequency of Therapist Fidelity Checklist Total Scores for all scored sessions.
Figure 2
Figure 2
100% stacked columns represent the proportion of the total number of sessions scored as high fidelity of delivery (Therapist Fidelity Checklist Total Score ≥13 out of 16, n=64) or moderate fidelity of delivery (Therapist Fidelity Checklist Total Score of 8–12 out of 16, n=8). Shading indicates the score for each individual checklist item.
Figure 3
Figure 3
Abbreviations: UCP, unilateral cerebral palsy; Baby-BIM, infant-friendly bimanual therapy; Baby-CIMT, infant-friendly constraint-induced movement therapy. Box and whisker plots of the distribution of Therapist Fidelity Checklist Total Scores for (3a) Baby-BIM versus Baby-CIMT intervention groups (Baby-BIM, n=39; Baby-CIMT, n=33); (3b) Home visits 1–3 by the study therapist (n=45) versus home visits 4 or later (n=27); (3c) Prior pediatric experience (5–10 years, n=27; 10–15 years, n=21; 15–20 years, n=19; 20+ years, n=5); and Years of experience treating children with UCP (0–2 years, n=5; 4–6 years, n=5; 6–8 years, n=10; 8+ years, n=52). The dotted line indicates a Therapist Fidelity Checklist Total Score of 13 out of 16 (>80%), corresponding to high fidelity of delivery.
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