TY - JOUR
T1 - Development of a Pediatric Goal-Centered Upper Limb Spasticity Home Exercise Therapy Program for Use in a Phase-III Trial of Abobotulinumtoxina (Dysport ® )
AU - Shierk, Angela
AU - Jiménez-Moreno, A. Cecilia
AU - Roberts, Heather
AU - Ackerman-Laufer, Shirley
AU - Backer, Gretchen
AU - Bard-Pondarre, Rachel
AU - Cekmece, Cigdem
AU - Pyrzanowska, Weronika
AU - Vilain, Claire
AU - Delgado, Mauricio R.
N1 - Funding Information:
The authors wish to acknowledge the feedback from the trial investigators and their teams as well as the patients and their families. We also thank Anita Chadha-Patel, PhD (ACP Clinical Communications Ltd, funded by Ipsen Pharma) for editorial support in the development of this manuscript.
Publisher Copyright:
© 2018, © 2018 The Author(s). Published with license by Taylor and Francis Group, LLC.
PY - 2019/3/4
Y1 - 2019/3/4
N2 - Aims: To create a standardized home exercise therapy program that could be implemented by international sites to provide a consistent level of therapeutic intervention for pediatric patients participating in an ongoing Phase-III, randomized, controlled trial of repeat abobotulinumtoxinA injections for pediatric upper limb spasticity (NCT02106351). Methods: Physical therapists, occupational therapists, and medical doctors worked collaboratively to design an exercise therapy program to be implemented in the home setting. In this article, we describe the development process and the finalized program that is currently being used in the Phase-III trial. Results: The final program is presented as a “toolbox” for therapists, and includes a standardized step-wise process for choosing the most appropriate exercises and functional activities to achieve the agreed treatment goals of each abobotulinumtoxinA injection. The core toolbox includes: a clear protocol for clinicians, information sheets, signature of commitment forms, exercise score charts, and the library of exercises and functional activities that therapists choose from to aid the patient in achieving their treatment goals. Conclusions: Implementation of this home therapy program provides a standardized background of good practice against which to test the efficacy of abobotulinumtoxinA. Preliminary data show that the program is readily accepted by patients and their families.
AB - Aims: To create a standardized home exercise therapy program that could be implemented by international sites to provide a consistent level of therapeutic intervention for pediatric patients participating in an ongoing Phase-III, randomized, controlled trial of repeat abobotulinumtoxinA injections for pediatric upper limb spasticity (NCT02106351). Methods: Physical therapists, occupational therapists, and medical doctors worked collaboratively to design an exercise therapy program to be implemented in the home setting. In this article, we describe the development process and the finalized program that is currently being used in the Phase-III trial. Results: The final program is presented as a “toolbox” for therapists, and includes a standardized step-wise process for choosing the most appropriate exercises and functional activities to achieve the agreed treatment goals of each abobotulinumtoxinA injection. The core toolbox includes: a clear protocol for clinicians, information sheets, signature of commitment forms, exercise score charts, and the library of exercises and functional activities that therapists choose from to aid the patient in achieving their treatment goals. Conclusions: Implementation of this home therapy program provides a standardized background of good practice against which to test the efficacy of abobotulinumtoxinA. Preliminary data show that the program is readily accepted by patients and their families.
KW - AbobotulinumtoxinA
KW - botulinum toxin
KW - cerebral palsy
KW - home therapy program
KW - occupational therapy
KW - physical therapy
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U2 - 10.1080/01942638.2018.1486346
DO - 10.1080/01942638.2018.1486346
M3 - Article
C2 - 30204515
AN - SCOPUS:85053415323
SN - 0194-2638
VL - 39
SP - 124
EP - 135
JO - Physical and Occupational Therapy in Pediatrics
JF - Physical and Occupational Therapy in Pediatrics
IS - 2
ER -