Development of a Pediatric Goal-Centered Upper Limb Spasticity Home Exercise Therapy Program for Use in a Phase-III Trial of Abobotulinumtoxina (Dysport^®)

Abstract

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.

Keywords:

• AbobotulinumtoxinA
• botulinum toxin
• cerebral palsy
• home therapy program
• occupational therapy
• physical therapy

Acknowledgments

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.

Disclosure statement

The authors received payment to train clinicians on intervention protocols related to the study. All authors (external from Ipsen) have been investigators in Ipsen-sponsored clinical trials (including the presented PULS study), and they or their institutions have received payment for participation. CV is employed by Ipsen Pharma. In addition, ACJ was employed directly by Ipsen as expert consultant towards the development of this manual.

Additional information

Notes on contributors

Angela Shierk

Angela Shierk, PhD, OTR, is an Occupational Therapist, Department of Clinical Research, Texas Scottish Rite Hospital for Children, Dallas, TX, USA, and Adjunct Faculty, Texas Woman’s University, Denton, TX, USA.

A. Cecilia Jiménez-Moreno

Cecilia Jiménez-Moreno, PhD is a Research Physiotherapist currently at the University of Newcastle, Institute of Genetic Medicine, and previously at Hospital San José Celaya, Celaya, Guanajuato, Mexico.

Heather Roberts

Heather Roberts, PhD, OTR, is an Occupational Therapist, Department of Clinical Research, Texas Scottish Rite Hospital for Children, Dallas, TX, USA, and Assistant Professor, Texas Woman’s University, Denton, TX, USA.

Shirley Ackerman-Laufer

Shirley Ackerman-Laufer, B.P.T, M.Sc. is a Senior Physiotherapist at the Edmond & Lilly Safra Hospital for Children, Sheba Medical Center, Tel Hashomer, Israel.

Gretchen Backer

Gretchen Backer, BS, PT is currently the Director of Program Review at the Michigan Department of Health and Human Services and was at William Beaumont Hospital, Royal Oak, Michigan, USA at the time of this study.

Rachel Bard-Pondarre

Rachel Bard-Pondarre is a Lead Physiotherapist at the Centre Médico-Chirurgical de Réadaptation des Massues – Croix-Rouge Française, Lyon, France.

Cigdem Cekmece

Cigdem Cekmece is an Assistant Professor in the Yahya Kaptan Vocational School, Department of Occupational Therapy, at Kocaeli University, Izmit, Turkey.

Weronika Pyrzanowska

Weronika Pyrzanowska is a Senior Physiotherapist at the Non-public Healthcare Unit Mazovian Neurorehabilitation and Psychiatry Center in Zagorze, Wiazowna, Poland.

Claire Vilain

Claire Vilain is a Medical Development Director (Neurology) at Ipsen Innovation, Les Ulis, France.

Mauricio R. Delgado

Mauricio R. Delgado, M.D., is a Pediatric Neurologist, Texas Scottish Rite Hospital for Children, Dallas, TX, USA and Professor, Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.