Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy

Cerebral Palsy (CP) is the leading cause of disability in children, with the most widespread
type of CP being spastic CP which negatively affects physical function. Specifically it is
reported that there is an increase in energy expenditure and oxygen consumption in children
with CP. Single event multi level chemoneurolysis with abobotulinumtoxinA has been found to
be an effective treatment for patients with spasticity to reduce energy expenditure by
increasing walking efficiency; however many of these studies have conflicting methodological
approaches. Therefore this study aims to evaluate the single event multilevel chemoneurolysis
with Dysport® on energy expenditure and gait in children with spastic diplegia CP.

Inclusion Criteria:

- Age: 5-17 years. Must be <18 prior to injection.

- >10 kilograms at screening and injection visits

- Diagnosis of spastic diplegia or mild- to moderate spastic quadriplegia Cerebral Palsy

- Gross Motor Function Classification System level: I, II, III

- Ability to ambulate independently without aid, equinus gait

- Absent of joint or bone deformities

- Eligible to receive single-event multi-level chemoneurolysis (SEMLC)

- Cooperative and tolerant to testing procedures during clinic screening

- Presence of spasticity in one or both legs

- Be on a stable dose and regimen if on any prescribed medication/s

- Parent must have signed written informed consent and the Patient Authorization for Use
and Release of Health and Research Study Information

Exclusion Criteria:

- Ankle contractures no more than -10 degrees with the knee extended

- Hemiplegia

- Wheelchair dependent

- Received Botulinum toxin within previous 4 months

- Uncontrolled epilepsy or certain types of seizures

- Fracture in the study limb within previous 12 months

- Infection or skin disorder at planned injection site

- Shortness of breath or other respiratory issues

- Uncontrolled clinically significant medical condition

- Received phenol or alcohol block in the study limb within previous 6 months

- Surgery in the study limb within previous 12 months

- Serial casting within previous 12 months

- New physiotherapy and/or orthotic regimen <1 month before study start. (physiotherapy
and/or orthotic regimen will be permitted if it began >1 month before study start and
maintained throughout study)